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Catequentinib - Advenchen Laboratories/Jiangsu Chia Tai Tianqing Pharmaceutical

Drug Profile

Catequentinib - Advenchen Laboratories/Jiangsu Chia Tai Tianqing Pharmaceutical

Alternative Names: AL-3818; ALTN; Anlotinib; Anlotinib hydrochloride; FOCUS V

Latest Information Update: 02 Dec 2021

At a glance

  • Originator Advenchen Laboratories; Jiangsu Chia-Tai Tianqing Pharmaceutical
  • Developer Advenchen Laboratories; Akeso Biopharma; Chia Tai Tianqing Pharmaceutical Group; Henan Cancer Hospital; Peking University People's Hospital; Tianquan Pharmaceutical
  • Class Amines; Antineoplastics; Cyclopropanes; Ethers; Fluorinated hydrocarbons; Indoles; Quinolines; Small molecules
  • Mechanism of Action Fibroblast growth factor receptor antagonists; Platelet-derived growth factor beta receptor antagonists; Proto oncogene protein c-kit inhibitors; Vascular endothelial growth factor receptor 3 antagonists; Vascular endothelial growth factor receptor-1 antagonists; Vascular endothelial growth factor receptor-2 antagonists
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Ovarian cancer
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Non-small cell lung cancer
  • Phase III Alveolar soft part sarcoma; Colorectal cancer; Gastric cancer; Leiomyosarcoma; Nasopharyngeal cancer; Synovial sarcoma; Thyroid cancer
  • Phase II Bone cancer; Cancer; Cholangiocarcinoma; Ewing's sarcoma; Fallopian tube cancer; Gastrointestinal stromal tumours; Glioblastoma; Head and neck cancer; Liver cancer; Neuroendocrine tumours; Ovarian cancer; Peritoneal cancer; Renal cell carcinoma; Small cell lung cancer; Soft tissue sarcoma; Squamous cell cancer; Urogenital cancer
  • Phase I/II Acral lentiginous melanoma; Cervical cancer; Endometrial cancer
  • Phase I Breast cancer; Solid tumours

Most Recent Events

  • 30 Nov 2021 The First Affiliated Hospital of Zhengzhou University plans a phase II trial in Cervical cancer (Combination therapy, Late-stage disease, Metastatic disease, Recurrent, Second-line therapy or greater) (PO) in March 2022 (NCT05137171)
  • 18 Nov 2021 Chia Tai Tianqing Pharmaceutical Group plans a phase III trial for Soft tissue sarcoma (Combination therapy, Late-stage disease, First-line therapy) in China (NCT05121350)
  • 06 Oct 2021 Chia Tai Tianqing Pharmaceutical initiates enrolment in a phase II trial for Colorectal cancer (Combination therapy, First-line therapy, Unresectable, Metastatic disease, Late-stage diseases) in China (NCT05068206)

Development Overview

Introduction

Catequentinib (formerly anlotinib) is an orally bioavailable kinase inhibitor of receptor tyrosine, being jointly developed by Advenchen Laboratories and Jiangsu Chia-Tai Tianqing Pharmaceutical (a subsidiary of Sino Biopharmaceutical), for the treatment of advanced cancers. The antiangiogenic small molecule targets multiple receptor tyrosine kinases including, VEGFR1, VEGFR2, VEGFR3, FGFR1/2/3, PDGFRa/β, c-Kit and MET. Sino Biopharmaceutical classifies catequentinib under chemical drug level 1.1. The product is available in China, as a third line treatment of patients with non-small cell lung cancer. Clinical development for the treatment of breast cancer, alveolar soft part sarcoma, cervical cancer, colorectal cancer, cholangiocarcinoma, endometrial cancer, Ewing's sarcoma, fallopian tube cancer, gastric cancer, gastrointestinal stromal tumours, hepatocellular carcinoma (liver cancer), leiomyosarcoma, nasopharyngeal carcinoma, neuroendocrine tumours, squamous cell cancer, ovarian cancer, peritoneal cancer, glioblastoma, renal cell carcinoma, small cell lung cancer, non-small cell lung cancer, soft tissue sarcoma, synovial sarcoma, solid tumours, acral lentiginous melanoma, thyroid cancer and urogenital cancer is underway in several countries.

Company Agreements

In June 2019, Chia Tia Tianqing Pharmaceutical Group and Akeso Biopharma announced the formation of Joint venture to research and commercialize Penpulimab together. Under the terms of agreement Chia Tai Tianqing will act as Akeso’s clinical development and commercialization partner for AK105 in China. This joint venture will provide Akeso with access to Chia Tai Tianqing’s strong commercial capabilities. Akeso has an exclusive right to develop combination therapies using Chia Tai Tianqing’s anlotinib; Chia Tai Tianqing will obtain the exclusive sales and pricing rights for penpulimab (AK105). Akeso provides all rights, title and interest in penpulimab (AK105) in exchange for 50% interest in the joint venture; Chia Tai Tianqing invests approximately Rmb344.7 mn in cash in exchange for 50% interest in the joint venture. [1]

Advenchen Laboratories entered into a research and development agreement Jiangsu Chia-Tai Tianqing Pharmaceutical to co-develop anlotinib for the treatment of cancer (Advenchen Laboratories website, September 2015).

Key Development Milestones

Non-small cell lung cancer

In May 2018, Chia-Tai Tianqing Pharmaceutical received approval for catequentinib capsules from the China Food and Drug Administration, as the third line treatment of patients with advanced non-small cell lung cancer. The company subsequently launched the product under the brandname FOCUS V® in China [2] .

In May 2020, Chia Tai Tianqing Pharmaceutical initiated a phase III trial to evaluate the efficacy and safety of TQB 2450 [See Adis Insight Drug profile 800053691]with or without catequentinib compared with placebo as consolidation treatment in subjects with locally advanced/unresectable (stage III) non-small cell lung cancer that has not progressed after prior concurrent/sequential chemoradiotherapy (NCT04325763; TQB2450-III-05). Primary objective of the trial is progression free survival (PFS) evaluated by independent review committee (IRC). A randomized, double-blind and imitation, placebo parallel control, multicenter phase III trial is designed to enroll 315 patients in China [3] .

In August 2019, Chia Tai Tianqing Pharmaceutical initiated a phase III trial to evaluate efficacy and safety of catequentinib combined with chemotherapy versus placebo combined with chemotherapy as first-line treatment in patients with advanced non-small cell lung cancer (ALTN-03-III-01; NCT04439890). The open label, randomised trial is enrolling 369 patients in China [4]

In January 2017, Jiangsu Chia-tai Tianqing completed the phase II/III ALTER0303 trial that indicated overall survival at 24 months, after treatment with catequentinib, thus meeting the defined endpoint in patients with advanced non-small cell lung cancer (NSCLC), compared with placebo (ALTN-03-IIB; NCT02388919). Eligible IIIB/IV NSCLC patients harbouring EGFR or ALK mutations, who progressed after at least two lines of prior therapies, were randomised 2:1 to receive catequentinib or placebo (12 mg, once-daily) till progression or intolerable toxicity. The double-blind, multi-center trial was initiated in February 2015 and enrolled 439 patients in China. In June 2017, data from the phase III portion of the trial were presented at the 53rd Annual Meeting of the American Society of Clinical Oncology (ASCO-2017) [5] [6] [7] .

Before September 2021, Hunan Cancer Hospital in collaboration with Chia-tai Tianqing Pharmaceutical completed a phase II trial which evaluated the catequentinib plus docetaxel versus docetaxel for the treatment of EGFR negative advanced non-small-cell lung cancer after disease progression on platinum-based therapy (NCT03624309; ALTER-L018). The open-label trial met its primary end point. It was initiated in October 2018 and enrolled 84 patients in China [8] .

In November 2020, Chia Tai Tianqing Pharmaceutical initiated a phase II trial of anlotinib hydrochloride combined with docetaxel in EGFR mutations advanced non small cell lung cancer patients who have progressed after targeted therapy and chemotherapy (NCT04619563; SDZLEC2020-052-02). The open label, exploratory trial intends to enrol approximately 42 patients in China [9] .

In April 2019, Chia Tai Tianqing Pharmaceutical initiated the phase II ALTER-L029 trial to evaluate the efficacy and safety of catequentinib following concurrent chemoradiation in patients with stage III unresectable non-small cell lung cancer (2018YJZ47; NCT03743129). The open label trial intends to enrol approximately 90 patients in China [10] .

In December 2013, Jiangsu Chia-tai Tianqing Pharmaceutical initiated a phase II trial, which is evaluating the pharmacodynamics of catequentinib in patients with advanced non-small cell lung cancer (ALTN-03-II 1.2-2; NCT02029209). The randomised, double-blind, placebo-controlled trial will enrol approximately 110 patients who have previously failed two lines of chemotherapy in China [11] .

Jiangsu Chia-tai Tianqing Pharmaceutical initiated the randomised, double-blind, placebo-controlled phase II ALTER0302 trial in August 2013, to assess the efficacy and safety of catequentinib in patients with advanced, heavily pretreated non-small cell lung cancer (ALTN-03-II; NCT01924195). The trial enrolled 117 patients in China, and was completed in October 2015 [12] .

Akeso initiated a Ib/II trial to evaluate cadonilimab (AK 104) [See Adis Insight Drug profile 800038084] plus catequentinib (anlotinib) in patients with non-small cell lung cancer (NSCLC), before April 2021 (AK104-208; NCT04646330). The single arm, two cohorts, randomised study intends to enrol approximately 120 participants in China. In September 2021, the company presented efficacy and safety data from the trial at the 46th European Society for Medical Oncology Congress (ESMO-2021) [13] [14] .

Prior to January 2021, Chia Tai Tianqing Pharmaceutical initiated a phase I/II trial of anlotinib in combination with TQB 2450 [see AdisInsight RDI 800053691] in EGFR+ advanced non-small scale lung cancer patients, who failed prior EGFR TKI therapies (ChiCTR1900026273; ALTER-L038). The trial intends to enroll approximately 63 patients in China [15] . In June 2021, initial efficacy and safety data from the trial presented at the 57th Annual Meeting of the American Society of Clinical Oncology (ASCO-2021) [16] .

In December 2018, Chia Tai Tianqing Pharmaceutical Group and Sichtrial to uan Cancer Hospital and Research Institute initiated a phase I/II to investigate the safety and efficacy of catequentinib in combination with platinum and pemetrexed in T790M mutation negative, metastatic non-squamous non-small cell lung cancer (NSCLC) after the failure of EGFR-tyrosine kinase inhibitors (TKIs) (NCT03706287; ALTER-L022). The primary objective of study is to determine progression free survival, dose limiting toxicities and maximum tolerated dose. The open-label trial intends to enrol approximately 62 patients in China [17] .

In June 2019, Chia Tai Tianqing Pharmaceutical initiated a phase I trial to evaluate the safety and efficacy of APL 502 injection combined with catequentinib in patients with advanced non-small cell lung cancer (TQB2450Ib01; NCT03910127). The randomised, double-blind trial intends to enrol approximately 90 patients in China [18] .

In March 2019, Chia Tai Tianqing Pharmaceutical initiated a phase I trial to evaluate efficacy and safety of anlotinib combined with pemetrexed and carboplatin followed by maintenance therapy with anlotinib plus pemetrexed as the first-line treatment in patients with advanced non-squamous non-small scale lung cancer (NCT03790228; ALTER L012). The open-label trial intends to enroll approximately 43 patients in China [19] . In June 2021, initial safety and efficacy results from the trial were presented at the 57th Annual Meeting of the American Society of Clinical Oncology (ASCO-2021) [20] .

catequentinib has also demonstrated anti-tumour efficacy in human HT29 colon cancer, Bel-7402 liver cancer xenografts and human A549 non-small cell lung cancer xenografts.

Breast cancer

In May 2019, Chia Tai Tianqing Pharmaceutical initiated a phase I trial to evaluate the efficacy and safety of TQB 2450 [see Adis profile 800053691] in combination with anlotinib treatment for patients with triple receptor negative breast cancer treated after failure of standard therapy (TQB2450Ib07; NCT03855358). The open label trial intends to enrol approximately 30 patients in China [21] . In June 2021, data were presented at the 57th Annual Meeting of the American Society of Clinical Oncology (ASCO-2021) [803582388].

Gastrointestinal stromal tumours (GIST)

In October 2018, Chia-Tai Tianqing Pharmaceutical initiated a phase II trial exploring catequentinib in the treatment of GIST patients, who failed prior imatinib therapy (NCT04106024; 2018YJZ42). The open label trial is enrolling approximately 60 patients in the US [22] .

Glioblastoma

In September 2021, Nanjing University Medical School in collaboration with Chia Tai Tianqing Pharmaceutical initiated phase II trial to investigate the safety and efficacy of penpulimab [See ADIS Insight Drug Profile 800050249] with anlotinib (catequentinib) and radiotherapy adjuvant therapy in MGMT unmethylated newly diagnosed glioblastoma (NCT05033587; 2021-252-02). The open-label single-arm, exploratory, two-stage design trial intends to enroll approximately 28 participants in China [23] .

Sarcoma

In August 2017, Advenchen Laboratories initiated the phase III APROMISS trial to evaluate the safety and efficacy of catequentinib in patients with metastatic or advanced alveolar soft part sarcoma, leiomyosarcoma and synovial sarcoma (AL3818-US-004; NCT03016819). The open-label, crossover, randomised trial will enrol approximately 219 patients in the US and Italy [24] . As of June 2021, enrolment of patients for synovial sarcoma has been completed in the trial. In June 2021, efficacy and safety data from the trial in synovial sarcoma were presented at the 57th Annual Meeting of the American Society of Clinical Oncology (ASCO-2021) [25] .

Jiangsu Chia-tai Tianqing initiated the phase II/III ALTER0203 trial to evaluate catequentinib in patients of soft tissue sarcoma (ALTN-02-IIB; NCT02449343). The randomised, double-blind and placebo-controlled trial intends to enrolled 233 patients in China. Progression free survival will be evaluated as a primary endpoint in the study. In September 2019, efficacy and safety data were presented at the 44th European Society for Medical Oncology Congress (ESMO-2019) [26] [27] [28] . In May 2020, the company presented efficacy data from the trial at the 56th Annual Meeting of the American Society of Clinical Oncology (ASCO-2020) [29] .

In April 2020, Chia Tai Tianqing Pharmaceutical initiated a phase II trial to evaluate safety and efficacy of catequentinib for the treatment of recurrent high grade glioma (NCT04822805; H2CH2020M504). The Open-label, single arm study intends to enrol 27 patients in China [30] . In September 2021, the company presented the interim safety and efficacy data at 46th European Society for Medical Oncology Congress [31] .

In January 2018, Peking University People's Hospital initiated a phase II study to explore the activity of catequentinib combined with irinotecan [see Adis Insight drug profile800000748] in patients with relapsed and metastatic Ewing Sarcoma (PKUPH-EWS-02; NCT03416517). The primary outcome measure of the study is to measure objective response rate at 12 weeks. The open-label study intends to enrol approximately 22 patients in China [32] .

In June 2018, Jiangsu Chia-tai Tianqing Pharmaceutical completed the phase II ALTN/STS trial that assessed the safety and efficacy of catequentinib as second-line therapy in patients with advanced soft tissue sarcoma (ALTN-02-II; NCT01878448). The primary endpoint was tumour size which was assessed every 42 days up to 48 months. The open-label trial was initiated in April 2013 and enrolled 166 patients in China [33] .

In June 2019, Chia Tai Tianqing Pharmaceutical initiated a phase Ib trial to evaluate the safety and efficacy of catequentinib in combination with APL 502 injection (see AdisInsight drug profile 800053691) in patients with advanced mutation positive non-small cell lung cancer (TQB2450-Ib-11; NCT03983928). The open-label, non-randomised trial intends to enrol approximately 30 patients in China [34] .

Squamous cell cancer (Oesophagus)

Chia-tai Tianqing Pharmaceutical, in July 2018, completed the phase II ALTER1102 that investigated the efficacy and safety of catequentinib with placebo in patients with oesophageal squamous cell carcinoma (ALTN-11-II; NCT02649361). The primary end point of the trial was to determine progress free survival (PFS) from randomisation each 42 days up to 24 months. The randomised, double-blind trial was initiated in January 2016 and recruited 164 participants in China [35] .

In October 2019, Henan Cancer Hospital and Chia-tai Tianqing Pharmaceutical initiated a phase II trial evaluating catequentinib in the first-line treatment for patients with advanced oesophageal squamous cell carcinoma in combination with paclitaxel, cisplatin (2019315; NCT04063683). The open label trial intends to enrol approximately 47 patients in China [36] . In June 2021, data from the trial were presented at the 57th Annual Meeting of the American Society of Clinical Oncology (ASCO-2021) [37] .

Thyroid cancer

In December 2019, Jiangsu Chia-tai Tianqing Pharmaceutical completed the phase II/III ALTER01032 trial that compared the efficacy and safety of catequentinib with placebo in patients with 131I-refractory differentiated thyroid cancer (ALTN01IIDTC; NCT02586337). The randomised, double-blind, trial was initiated in July 2015 and enrolled 113 patients in China [38] . In May 2019, enrolment in the trial was completed. In September 2020, efficacy and safety results from the trial were presented at the 45th European Society for Medical Oncology Congress (ESMO-2020) [39] .

In May 2019, the phase II/III ALTER01031 trial met its primary endpoint of progression-free survival. In September 2018, Jiangsu Chia-tai Tianqing Pharmaceutical completed the phase II/III ALTER01031 trial that compared the efficacy and safety of catequentinib with placebo in patients with medullary thyroid carcinoma (ALTN-01-IIMTC; NCT02586350). Progression free survival was evaluated as a primary endpoint in the study. The randomised, double-blind, parallel trial, initiated in July 2015, recruited 91 patients in China. In June 2019, efficacy and safety results from the trial were presented at the 55th Annual Meeting of the American Society of Clinical Oncology (ASCO-2019) [40] [41] . In May 2020, the company presented updated results from this trial at the 56th Annual Meeting of the American Society of Clinical Oncology (ASCO-2020) [42] [43] .

In April 2013, Jiangsu Chia-tai Tianqing Pharmaceutical initiated the phase II ALTN/MTC trial to assess the safety and efficacy of catequentinib oral capsule in patients with advanced medullary thyroid carcinoma (ALTN-01-IIA; NCT01874873). The open-label trial enrolled 58 patients in China. The trial was completed in December 2016 [44] .

In June 2015, Jiangsu Chia-tai Tianging Pharmaceutical initiated the phase II/III ALTER0503 trial to compare the efficacy and safety of catequentinib versus placebo in patients with advanced gastric cancer (ALTN-05-II; NCT02461407). The randomised, double-blind trial is designed to enrol approximately 378 patients in China [45] .

Acral lentiginous melanoma

Chia Tai Tianqing Pharmaceutical, in June 2019, initiated a phase I/II trial to evaluate the safety and efficacy of APL 502 injection combined with catequentinib in patients with advanced acral lentiginous melanoma (TQB2450Ib09; NCT03991975). The open label trial intends to enrol approximately 42 patients in China [46] .

Other solid tumours

The US FDA granted orphan drug designation for catequentinib in the treatment of ovarian cancer in 2015 (NCT04106024).

In May 2021, Chia Tai Tianqing Pharmaceutical initiated a phase III trial to evaluate the efficacy and safety of anlotinib hydrochloride and chemotherapy as a first line treatment in patients with RAS/BRAF wild type, unresectable metastatic colorectal cancer (ALTN8546;-02; ALTN-Ⅲ-02; NCT04854668). The randomised, open label trial will enrol approximately 698 participants in China [47] .

In September 2018, Jiangsu Chia-tai Tianqing Pharmaceutical initiated a phase III trial to compare catequentinib plus gemcitabine/cisplatin with placebo plus gemcitabine/cisplatin in previous untreated patients with recurrent/metastatic nasopharyngeal carcinoma, in order to verify the efficacy and security of catequentinib in metastatic nasopharyngeal carcinoma patients (NCT03601975; ALTN17III). The randomised trial is enrolling approximately 336 patients in China [48] .

In March 2019, Jiangsu Chia-tai Tianging Pharmaceutical completed the phase II/III ALTER0703 study that evaluated the safety and efficacy of catequentinib in patients with metastatic colorectal cancer, who progressed during or within 3 months following standard chemotherapies (ALTN-07-IIB; NCT02332499). The primary endpoint was the overall survival, assessed up to 24 months. The placebo controlled study, initiated in December 2014, enrolled 419 patients in China [49] .

In October 2021, Chia Tai Tianqing Pharmaceutical initiated a randomised phase II trial to compare the efficacy and safety of AK105 [See AdisInsigt drug profile 800050249] plus anlotinib and capecitabine/oxaliplatin (capeOx) , anlotinib plus CapeOx, bevacizumab Plus capeOx for the treatment of metastatic colorectal cancer (NCT05068206; ALTN-AK105-II-04). The open-label, multi-center trial intends to enroll approximately 120 patients in China.

In May 2020, Chia Tai Tianqing Pharmaceutical initiated a phase II trial to evaluate the combination of catequentinib and penpulimabin [see Adis Insight drug profile800050249] in patients with advanced head, neck and chest cancer (ALTN-AK105-II-01; NCT04203719). The open-label, single-arm, multi-cohort, multicenter study will enrol approximately 140 patients in China [50] . In June 2021, Chia Tai Tianqing Pharmaceutical presented the efficacy and safety data from the trial at the 57th Annual Meeting of the American Society of Clinical Oncology (ASCO-2021) [51] . In September 2021, the updated efficacy and safety data from the trial at the 46th European Society for Medical Oncology Congress (ESMO-2021) [52] .

In June 2020, Chia Tai Tianqing Pharmaceutical initiated the phase II trial of catequentinib in combination with a penpulimabin [see Adis Insight drug profile800050249] for patients with cholangiocarcinoma, colorectal cancer, gastric cancer, urogenital cancer, neuroendocrine tumours (NCT04207463). Primary endpoint of the study is percentage of subjects achieving overall response rate (ORR). The open- label, single-arm study is designed to enroll 150 patients in China [53] .

Chia Tai Tianqing Pharmaceutical in March 2020, initiated a phase II trial of catequentinib in combination with niraparib [see Adis Insight drug profile800028881] in patients with platinum-resistant recurrent ovarian cancer, fallopian tube cancer, and primary peritoneal cancer. The open-label, single arm, non-randomised trial will recruit approximately 40 patients in China [54] .

In April 2020, Chia Tai Tianqing Pharmaceutical Group initiated a phase II ALTER-H-004 trial to evaluate the effects and safety of catequentinib hydrochloride combined with transcatheter arterial chemoembolization (TACE) in hepatocellular carcinoma (liver cancer) patients at high risk of post surgery recurrence (KYLLSL-2019-185; NCT04213118). The open label trial is enrolling approximately 48 patients in China [55] . The primary endpoint is defined as disease free survival (DFS). As of April 2020, two patients were enrolled in the study [56] .

In November 2018, Akeso Biopharma initiated a phase II trial to evaluate the efficacy and safety of penpulimab [see Adis Insight drug profile800050249] plus anlotinib hydrochloride in the first-line treatment of patients with unresectable hepatocellular carcinoma (NCT04172571; AK105-203). The open-label trial is enrolling approximately 31 patients in China [57] . As of Jan 2020, 31 patients received combined therapy. In May 2020, the company presented results from this trial at the 56th Annual Meeting of the American Society of Clinical Oncology (ASCO-2020) [58] .

In March 2019, Chia Tai Tianqing Pharmaceutical initiated a phase II trial of catequentinib in patients with platinum-resistant or refractory high grade serous adenocarcinoma of ovarian, fallopian tube and peritoneum (1903198-19; OVA-2019-1; ChiCTR2000029654). The trial will recruit approximately 41 patients in China. In June 2021, safety and efficacy data from the trial were presented at the 57th Annual Meeting of the American Society of Clinical Oncology (ASCO-2021) [59] [60] [61] . In September 2021, results from the trial were presented at the 46th European Society for Medical Oncology Congress (ESMO-2021) [62] .

In January 2018, Chia-tai Tianqing Pharmaceutical initiated a phase II trial to evaluate the efficacy and safety of catequentinib, for the treatment of patients with gastroenteropancreatic neuroendocrine tumour G3 (ALTN-13-II; NCT03457844). The single group, open Label, multi-center study is intended to enrol approximately 60 patients in China [63] .

In January 2018, Chia-tai Tianqing Pharmaceutical initiated a phase II trial to evaluate the safety and efficacy of catequentinib hydrochloride capsule in patients with primary malignant bone tumors with recurrence and distant metastases (NCT03527888; ALTN-15-II). The open label trial intends to enrol approximately 40 patients in China. In May 2020, results from the trial were presented at 56th Annual Meeting of the American Society of Clinical Oncology(ASCO-2020). Results showed promising activity of catequentinib in patients with relapsed or metastatic primary malignant bone tumor and an acceptable toxicity [64] [65] .

In May 2019, Jiangsu Chia-tai Tianqing Pharmaceutical completed the phase II ALTER1202 trial which evaluated the efficacy and safety, of catequentinib, in patients with advanced small cell lung cancer (ALTN-12-II; NCT03059797). The randomised, double-blind, placebo-controlled trial initiated in March 2017, enrolled 120 patients in China. In the trial no new adverse events were observed. In September 2019, efficacy results from the trial were presented at the 44th European Society for Medical Oncology Congress (ESMO-2019) [66] [67] . In September 2020, efficacy and adverse event results from the trial were presented at the 45th European Society for Medical Oncology Congress (ESMO-2020) [68] .

Prior to June 2021, Tianquan Pharmaceutical completed a phase II trial in patients with small-cell lung cancer (ChiCTR2000035043). Earlier in January 2019, Tianquan Pharmaceutical initiated the phase II trial to assess anlotinib combined with etoposide plus cisplatin/carboplatin as first-line therapy in patients with extensive-stage small cell lung cancer (SCLC). The trial enrolled 20 patients in China [69] [70] .

In September 2016, Jiangsu Chia-tai Tianqing Pharmaceutical initiated the phase II ALTER0802 trial to assess the efficacy and safety of catequentinib, as compared with placebo, in patients with hepatocellular carcinoma (ALTN-08-II; NCT02809534). The single-group, open-label trial will enrol approximately 60 patients in China. In September 2019, results from the study were presented at the 44th European Society for Medical Oncology Congress (ESMO-2019) [71] [72] .

In December 2013, Jiangsu Chia-tai Tianqing Pharmaceutical initiated a phase II clinical trial of catequentinib in patients with advanced renal cell carcinoma that have failed or are intolerant to TKIs therapy (ALTN-06-IIB; NCT02072044). The open-label trial is enrolled 60 patients in China [73] .

Also, in December 2013, Jiangsu Chia-tai Tianqing Pharmaceutical initiated a randomised, open-label phase II trial to assess the efficacy and safety of catequentinib, compared to sunitinib, in patients with advanced renal cell carcinoma (ALTN-06-IIA; NCT02072031). The trial is enrolling previously untreated patients, as well as patients that have failed or are resistant to chemotherapy/cytokine therapy. Approximately 180 patients will be enrolled in China [74] .

In August 2015, Chia Tai Tianqing Pharmaceutical Group Co. initiated a phase II trial to evaluate the efficacy and safety of catequentinib in patients with advanced malignancy (NCT04216082; ALTN-00-II). The open-label trial was initiated in August 2013, and enrolled 93 patients in China [75] .

In February 2020, Chia Tai Tianqing Pharmaceutical initiated a phase I/II trial of TQB 2450 [see Adis Insight drug profile 800053691] combined with catequentinib in patients with relapsed or refractory epithelial ovarian, fallopian tube, or primary peritoneal cancer (NCT04236362; TQB2450-Ib-10). The open-label trial is designed to enrol approximately 30 participants in China [76] . In June 2021, efficacy and safety results were presented at the 57th Annual Meeting of the American Society of Clinical Oncology (ASCO-2021) [77]

In June 2019, Advenchen Laboratories terminated a two-part phase Ib/IIa trial that intended to investigate the safety, pharmacokinetics and efficacy of catequentinib in female patients with recurrent or metastatic endometrial, ovarian or cervical cancer (AL3818-US-001; NCT02558348). The open-label trial was initiated in November 2015 and enrolled 12 patients in the US [78] . Advenchen Laboratories in June 2017, presented safety and pharmacokinetics data of one patient with ovarian and two patients with endometrium cancer at the 53rd Annual Meeting of the American Society of Clinical Oncology (ASCO-2017) [79] .

Advenchen Laboratories, in December 2015, initiated the phase Ib/IIa AL3818 trial to evaluate the safety and efficacy of adding oral catequentinib to standard platinum-based chemotherapy such as carboplatin plus paclitaxel, concurrently and continued as a maintenance therapy for up to 12 months, in female patients with recurrent or metastatic endometrial, ovarian, fallopian, primary peritoneal or cervical carcinoma (AL3818-US-002; NCT02584478). The primary endpoint of phase Ib part of the study will be to determine the recommended phase II dose through the evaluation of DLT events and phase IIa part will evaluate the objective response rates. The open-label, single-group trial will recruit 48 patients in the US [80] .

In June 2019, Chia Tai Tianqing Pharmaceutical Group initiated a phase I trial to evaluate TQB 2450 [see AdisInsight drug profile800053691] combined with anlotinib in patients with advanced solid tumors (TQB2450-Ib-04; NCT03897283). The open-label trial intends to enrol approximately 22 patients in China [81] .

In August 2018, Jiangsu Chia-tai Tianqing Pharmaceutical initiated a phase I trial to assess the pharmacokinetics of catequentinib in patients with advanced solid tumours with high fat diet (ALTN-I-05; NCT02825563). The open-label, randomised trial initiated in June 2016, enrolled 22 patients in China [82] .

Jiangsu Chia-tai Tianqing Pharmaceutical initiated a phase I trial to assess the tolerance, pharmacokinetics and pharmacodynamics of catequentinib in patients with advanced solid tumours (ALTN-I-07; NCT02752516). The open-label, single-group trial enrolled 16 patients in China [83] .

In August 2017, Jiangsu Chia-tai Tianqing Pharmaceutical completed a phase I pharmacokinetics study which investigated the absorption, metabolism and excretion of [14C]-catequentinib in advanced cancer patients (ALTN-I-R; NCT02622932). The open-label trial that was initiated in December 2015 enrolled six patients in China [84] .

Jiangsu Chia-tai Tianqing Pharmaceutical initiated an open-label, interventional phase I clinical trial in May 2011, to assess the pharmacokinetics and tolerability, and to determine the maximum tolerated dose, dose-limiting toxicity and dosage regimen for phase II trials of catequentinib (ALTN; ALTN-I-01; NCT01833923). The trial enrolled 35 patients with advanced cancer in China, and was completed in October 2015 [85] .

Drug Properties & Chemical Synopsis

  • Route of administration PO
  • Formulation Capsule, unspecified
  • Class Amines, Antineoplastics, Cyclopropanes, Ethers, Fluorinated hydrocarbons, Indoles, Quinolines, Small molecules
  • Target Fibroblast growth factor receptor; Platelet-derived growth factor beta receptor; Proto oncogene protein c-kit; Vascular endothelial growth factor receptor 3; Vascular endothelial growth factor receptor-1; Vascular endothelial growth factor receptor-2
  • Mechanism of Action Fibroblast growth factor receptor antagonists; Platelet-derived growth factor beta receptor antagonists; Proto oncogene protein c-kit inhibitors; Vascular endothelial growth factor receptor 3 antagonists; Vascular endothelial growth factor receptor-1 antagonists; Vascular endothelial growth factor receptor-2 antagonists
  • WHO ATC code

    L01X-E (Protein kinase inhibitors)

  • EPhMRA code

    L1H (Protein Kinase Inhibitor Antineoplastics)

  • Chemical name 1-[[4-[(4-fluoro-2-methyl-1H-indol-5-yl)oxy]-6-methoxyquinolin-7-yl]oxymethyl]cyclopropan-1-amine
  • Molecular formula C23 H22 F N3O3
  • SMILES C1(CC1)(N)COC1=C(C=C2C(=CC=NC2=C1)OC1=C(C2C=C(NC=2C=C1)C)F)OC
  • Chemical Structure
  • CAS Registry Number 1058156-90-3

Biomarkers Sourced From Trials

Indication Biomarker Function Biomarker Name Number of Trials

adenocarcinoma

Outcome Measure

Fibroblast Growth Factor (FGF2)

CD95 (APO-1/Fas)

1

1

adenocarcinoma

Brief Title

PD-L1/CD274

Epidermal growth factor receptor (EGFR)

1

1

adenocarcinoma

Arm Group Description

PD-L1/CD274

1

adenocarcinoma

Detailed Description

HER2/ERBB2

Epidermal growth factor receptor (EGFR)

C-Kit

1

1

1

adenocarcinoma

Eligibility Criteria

tumor necrosis factor receptor superfamily, member 4

tumor necrosis factor receptor superfamily member 9

SERPINA2

ROS1

ring finger protein 2

RAD51

PD-L2

PD-L1/CD274

PD-1/CD279

partner and localizer of BRCA2

PARP-1

Oxalacetic acid

N-acylethanolamine acid amidase

Microsatellite Instable (MSI)

methylmalonic aciduria (cobalamin deficiency) cblB type

membrane associated guanylate kinase, WW and PDZ domain containing 1

Luteinizing hormone (LH)

Hydrocortisone

HER2/ERBB2

FANCA

Epidermal growth factor receptor (EGFR)

cytotoxic T-lymphocyte-associated protein 4

Creatinine

collagen, type XI, alpha 2

CHK2

BRCA2

BRCA1 interacting protein C-terminal helicase 1

BRCA1

BAP1

ATR

Ataxia telangiectasia mutated

anthrax toxin receptor 1

Anaplastic lymphoma receptor tyrosine kinase (ALP)

ALT

1

1

1

4

1

1

1

2

1

1

1

1

1

1

1

1

1

1

4

1

8

2

1

1

1

1

1

1

1

1

1

1

7

1

adenocarcinoma

Official Title

RET

PD-L1/CD274

Epidermal growth factor receptor (EGFR)

2

2

1

adenocarcinoma

Brief Summary

Epidermal growth factor receptor (EGFR)

C-Kit

2

2

adenosquamous carcinoma

Eligibility Criteria

tumor necrosis factor receptor superfamily, member 4

tumor necrosis factor receptor superfamily member 9

PD-L1/CD274

PARP-1

cytotoxic T-lymphocyte-associated protein 4

collagen, type XI, alpha 2

1

1

1

1

1

1

adenosquamous carcinoma

Official Title

RET

1

advanced breast cancer

Outcome Measure

PD-L1/CD274

1

advanced breast cancer

Brief Title

HER2/ERBB2

Fibroblast growth factor receptor 2 (FGFR2)

Fibroblast growth factor receptor 1 (FGFR1)

3

1

1

advanced breast cancer

Detailed Description

HER2/ERBB2

Fibroblast growth factor receptor 2 (FGFR2)

Fibroblast growth factor receptor 1 (FGFR1)

4

1

1

advanced breast cancer

Eligibility Criteria

SERPINA2

ring finger protein 2

RAD51

Progesterone

partner and localizer of BRCA2

N-acylethanolamine acid amidase

methylmalonic aciduria (cobalamin deficiency) cblB type

membrane associated guanylate kinase, WW and PDZ domain containing 1

L-Aspartic acid

HER2/ERBB2

Fibroblast growth factor receptor 2 (FGFR2)

Fibroblast growth factor receptor 1 (FGFR1)

FANCA

Estrogen receptor alpha (ER alpha)

cytokine inducible SH2-containing protein

CHK2

BRCA2

BRCA1 interacting protein C-terminal helicase 1

BRCA1

Bilirubin

BAP1

ATR

Ataxia telangiectasia mutated

anthrax toxin receptor 1

ALT

1

1

1

1

1

1

1

1

1

7

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

advanced breast cancer

Official Title

HER2/ERBB2

Fibroblast growth factor receptor 2 (FGFR2)

Fibroblast growth factor receptor 1 (FGFR1)

4

1

1

advanced breast cancer

Brief Summary

PD-L1/CD274

HER2/ERBB2

Fibroblast growth factor receptor 2 (FGFR2)

Fibroblast growth factor receptor 1 (FGFR1)

1

4

1

1

alveolar soft part sarcoma

Brief Summary

FLT4

1

alveolar soft part sarcoma

Eligibility Criteria

p63

Alkaline phosphatase (ALPL)

1

1

anaplastic astrocytoma

Detailed Description

Fibroblast growth factor receptor 1 (FGFR1)

1

biliary cancer

Eligibility Criteria

Oxalacetic acid

N-acylethanolamine acid amidase

Creatinine

ALT

1

1

1

1

brain metastases

Brief Title

Epidermal growth factor receptor (EGFR)

1

brain metastases

Detailed Description

Fibroblast growth factor receptor 1 (FGFR1)

1

brain metastases

Eligibility Criteria

ROS1

Mannitol

Epidermal growth factor receptor (EGFR)

Anaplastic lymphoma receptor tyrosine kinase (ALP)

1

1

2

1

brain metastases

Official Title

Epidermal growth factor receptor (EGFR)

1

brain metastases

Brief Summary

Epidermal growth factor receptor (EGFR)

1

cancer

Brief Summary

FLT4

1

carcinoma

Outcome Measure

Fibroblast Growth Factor (FGF2)

1

carcinoma

Brief Title

BRAF

1

carcinoma

Detailed Description

RAS

BRAF

1

1

carcinoma

Eligibility Criteria

Thyroxine (T4)

Thyroid stimulating hormone beta (TSH)

RAS

PGR

PD-L2

PD-1/CD279

PARP-1

Luteinizing hormone (LH)

HER2/ERBB2

FSH

Estrogen receptor alpha (ER alpha)

cytotoxic T-lymphocyte-associated protein 4

collagen, type XI, alpha 2

BRAF

Adenosine diphosphate ribose

1

1

1

1

1

1

1

1

2

1

2

1

1

1

1

carcinoma

Official Title

RET

BRAF

1

1

carcinoma

Brief Summary

RAS

BRAF

1

1

cervical cancer

Eligibility Criteria

tumor necrosis factor receptor superfamily, member 4

tumor necrosis factor receptor superfamily member 9

PD-L2

PD-L1/CD274

PD-1/CD279

PARP-1

cytotoxic T-lymphocyte-associated protein 4

collagen, type XI, alpha 2

1

1

1

1

1

1

2

1

cervical cancer

Official Title

RET

2

cervical cancer

Outcome Measure

Fibroblast Growth Factor (FGF2)

1

cholangiocarcinoma

Detailed Description

HER2/ERBB2

1

cholangiocarcinoma

Eligibility Criteria

SERPINA2

ring finger protein 2

RAD51

partner and localizer of BRCA2

Oxalacetic acid

N-acylethanolamine acid amidase

methylmalonic aciduria (cobalamin deficiency) cblB type

membrane associated guanylate kinase, WW and PDZ domain containing 1

HER2/ERBB2

FANCA

Creatinine

CHK2

BRCA2

BRCA1 interacting protein C-terminal helicase 1

BRCA1

BAP1

ATR

Ataxia telangiectasia mutated

anthrax toxin receptor 1

ALT

1

1

1

1

1

1

1

1

2

1

1

1

1

1

1

1

1

1

1

1

cholangiocarcinoma

Official Title

PD-L1/CD274

1

Chordoma

Brief Title

Chordoma

1

Chordoma

Official Title

Chordoma

1

clear cell sarcoma

Brief Summary

FLT4

1

colon cancer

Brief Title

BRAF

1

colon cancer

Detailed Description

RAS

BRAF

1

1

colon cancer

Eligibility Criteria

RAS

BRAF

1

1

colon cancer

Official Title

BRAF

1

colon cancer

Brief Summary

RAS

BRAF

1

1

colorectal cancer

Outcome Measure

Interleukin-6 (IL-6)

1

colorectal cancer

Brief Title

BRAF

2

colorectal cancer

Detailed Description

RAS

BRAF

1

1

colorectal cancer

Eligibility Criteria

RAS

PD-L1/CD274

PD-1/CD279

Microsatellite Instable (MSI)

Hydrocortisone

HER2/ERBB2

cytotoxic T-lymphocyte-associated protein 4

BRAF

2

2

1

1

1

1

1

2

colorectal cancer

Official Title

PD-L1/CD274

BRAF

1

2

colorectal cancer

Brief Summary

RAS

BRAF

2

2

diffuse large B cell lymphoma

Arm Group Description

RET

1

early breast cancer

Eligibility Criteria

PGR

HER2/ERBB2

Estrogen receptor alpha (ER alpha)

1

1

1

endometrial cancer

Eligibility Criteria

PD-L2

PD-1/CD279

PARP-1

Microsatellite Instable (MSI)

mannose receptor, C type 1

cytotoxic T-lymphocyte-associated protein 4

collagen, type XI, alpha 2

1

1

1

1

1

1

1

endometrial cancer

Official Title

RET

2

endometrial cancer

Outcome Measure

Fibroblast Growth Factor (FGF2)

1

Ewing's sarcoma

Eligibility Criteria

CALCA

1

Extranodal NK-T-cell lymphoma

Eligibility Criteria

Fibrinogen

1

fallopian tube cancer

Eligibility Criteria

PD-L2

PD-1/CD279

PARP-1

Estrogen receptor alpha (ER alpha)

cytotoxic T-lymphocyte-associated protein 4

collagen, type XI, alpha 2

1

1

1

1

1

1

fallopian tube cancer

Official Title

RET

2

fallopian tube cancer

Outcome Measure

Fibroblast Growth Factor (FGF2)

1

gallbladder cancer

Eligibility Criteria

Oxalacetic acid

N-acylethanolamine acid amidase

Creatinine

ALT

1

1

1

1

gallbladder cancer

Official Title

PD-L1/CD274

1

gastric cancer

Brief Title

PD-L1/CD274

1

gastric cancer

Arm Group Description

PD-L1/CD274

1

gastric cancer

Detailed Description

HER2/ERBB2

1

gastric cancer

Eligibility Criteria

SERPINA2

ring finger protein 2

RAD51

PD-L1/CD274

partner and localizer of BRCA2

Microsatellite Instable (MSI)

methylmalonic aciduria (cobalamin deficiency) cblB type

membrane associated guanylate kinase, WW and PDZ domain containing 1

Hydrocortisone

HER2/ERBB2

FANCA

CHK2

BRCA2

BRCA1 interacting protein C-terminal helicase 1

BRCA1

BAP1

ATR

Ataxia telangiectasia mutated

anthrax toxin receptor 1

1

1

1

1

1

2

1

1

1

5

1

1

1

1

1

1

1

1

1

gastric cancer

Official Title

PD-L1/CD274

2

gastrointestinal cancer

Eligibility Criteria

PD-L1/CD274

Nuclear protein Ki67

Microsatellite Instable (MSI)

Hydrocortisone

HER2/ERBB2

1

1

1

1

1

gastrointestinal cancer

Official Title

PD-L1/CD274

1

gastrointestinal stromal tumours

Brief Summary

PDGFRA

1

glioblastoma

Brief Title

MGMT

2

glioblastoma

Arm Group Description

MGMT

1

glioblastoma

Detailed Description

VEGFR

PDGFRB

PDGFRA

MGMT

Fibroblast growth factor receptor 1 (FGFR1)

1

1

1

1

2

glioblastoma

Eligibility Criteria

VEGFR

PDGFRB

PDGFRA

MGMT

IDH1

Fibroblast growth factor receptor 1 (FGFR1)

1

1

1

2

1

1

glioblastoma

Official Title

MGMT

2

glioblastoma

Brief Summary

VEGFR

PDGFRB

PDGFRA

MGMT

Fibroblast growth factor receptor 1 (FGFR1)

1

1

1

2

1

glioma

Detailed Description

Fibroblast growth factor receptor 1 (FGFR1)

1

gynaecological cancer

Eligibility Criteria

PD-L2

PD-1/CD279

Microsatellite Instable (MSI)

mannose receptor, C type 1

cytotoxic T-lymphocyte-associated protein 4

1

1

1

1

1

leiomyosarcoma

Brief Summary

FLT4

1

leiomyosarcoma

Eligibility Criteria

p63

Alkaline phosphatase (ALPL)

1

1

liposarcoma

Brief Summary

FLT4

1

liver cancer

Arm Group Label

ADAM metallopeptidase domain 17

2

liver cancer

Outcome Measure

Alpha-fetoprotein (AFP)

1

liver cancer

Brief Title

ADAM metallopeptidase domain 17

3

liver cancer

Arm Group Description

ADAM metallopeptidase domain 17

2

liver cancer

Eligibility Criteria

Thyroid stimulating hormone beta (TSH)

Prothrombin (PT)

Oxalacetic acid

N-acylethanolamine acid amidase

Fibrinogen

Creatinine

ALT

Alpha-fetoprotein (AFP)

ADAM metallopeptidase domain 17

1

1

1

1

2

1

1

1

1

liver cancer

Official Title

ADAM metallopeptidase domain 17

1

liver metastases

Eligibility Criteria

Epidermal growth factor receptor (EGFR)

Anaplastic lymphoma receptor tyrosine kinase (ALP)

1

1

male breast cancer

Detailed Description

HER2/ERBB2

1

male breast cancer

Eligibility Criteria

SERPINA2

ring finger protein 2

RAD51

Progesterone

partner and localizer of BRCA2

methylmalonic aciduria (cobalamin deficiency) cblB type

membrane associated guanylate kinase, WW and PDZ domain containing 1

HER2/ERBB2

FANCA

CHK2

BRCA2

BRCA1 interacting protein C-terminal helicase 1

BRCA1

BAP1

ATR

Ataxia telangiectasia mutated

anthrax toxin receptor 1

1

1

1

1

1

1

1

2

1

1

1

1

1

1

1

1

1

malignant fibrous histiocytoma

Brief Summary

FLT4

1

malignant fibrous histiocytoma

Outcome Measure

T-cell surface antigen CD4

T-cell receptor T3 delta chain (CD3d)

T-cell receptor CD3-epsilon (CD3e)

T-Cell differentiation antigen CD8

PD-L2

PD-L1/CD274

PD-1/CD279

Nuclear protein Ki67

LAG-3 (CD223)

HAVCR2 (TIM-3)

cytotoxic T-lymphocyte-associated protein 4

CD3 gamma chain (CD3G)

1

1

1

1

1

1

1

1

1

1

1

1

malignant melanoma

Official Title

PD-L1/CD274

PD-1/CD279

1

1

nasopharyngeal cancer

Eligibility Criteria

Thyroxine (T4)

Thyroid stimulating hormone beta (TSH)

1

1

neuroblastoma

Brief Summary

N-Myc

1

neuroendocrine tumours

Eligibility Criteria

Nuclear protein Ki67

HER2/ERBB2

1

1

non-small cell lung cancer

Arm Group Label

Epidermal growth factor receptor (EGFR)

3

non-small cell lung cancer

Outcome Measure

Tumor Mutational Burden

PD-L1/CD274

Epidermal growth factor receptor (EGFR)

1

1

1

non-small cell lung cancer

Brief Title

ROS1

PD-L1/CD274

KRAS

Epidermal growth factor receptor (EGFR)

1

1

1

14

non-small cell lung cancer

Arm Group Description

Epidermal growth factor receptor (EGFR)

COL18A1

Alkaline phosphatase (ALPL)

3

1

2

non-small cell lung cancer

Detailed Description

ROS1

Fibroblast growth factor receptor 1 (FGFR1)

Epidermal growth factor receptor (EGFR)

C-Kit

Anaplastic lymphoma receptor tyrosine kinase (ALP)

1

1

10

1

1

non-small cell lung cancer

Eligibility Criteria

Thyroid stimulating hormone beta (TSH)

T-cell surface antigen CD4

ROS1

pregnancy specific beta-1-glycoprotein 2

PD-L1/CD274

PD-1/CD279

Mannitol

Luteinizing hormone (LH)

KRAS

FSH

Epidermal growth factor receptor (EGFR)

Cytokeratin 18

CEA

carcinoembryonic antigen related cell adhesion molecule 3

BRAF

Anaplastic lymphoma receptor tyrosine kinase (ALP)

1

1

22

1

5

1

1

4

2

3

63

3

1

1

1

46

non-small cell lung cancer

Official Title

ROS1

PD-L1/CD274

KRAS

Epidermal growth factor receptor (EGFR)

cytotoxic T-lymphocyte-associated protein 4

1

1

1

16

1

non-small cell lung cancer

Brief Summary

VEGFR

Tumor Mutational Burden

ROS1

PLK3

PDGFRB

PDGFRA

PD-L1/CD274

Fibroblast growth factor receptor 4 (FGFR4)

Fibroblast growth factor receptor 3 (FGFR3)

Fibroblast growth factor receptor 2 (FGFR2)

Fibroblast growth factor receptor 1 (FGFR1)

Fibroblast Growth Factor (FGF2)

Epidermal growth factor receptor (EGFR)

C-Kit

BRAF

Anaplastic lymphoma receptor tyrosine kinase (ALP)

1

1

3

1

1

1

2

1

1

1

1

1

19

10

2

4

oesophageal cancer

Arm Group Description

PD-L1/CD274

1

oesophageal cancer

Brief Title

PD-L1/CD274

2

oesophageal cancer

Eligibility Criteria

PD-L1/CD274

Microsatellite Instable (MSI)

Luteinizing hormone (LH)

Hydrocortisone

HER2/ERBB2

FSH

1

2

1

1

4

1

oesophageal cancer

Official Title

PD-L1/CD274

3

oligodendroglioma

Detailed Description

Fibroblast growth factor receptor 1 (FGFR1)

1

ovarian cancer

Eligibility Criteria

PD-L2

PD-1/CD279

PARP-1

Estrogen receptor alpha (ER alpha)

cytotoxic T-lymphocyte-associated protein 4

collagen, type XI, alpha 2

Adenosine diphosphate ribose

1

1

2

1

1

2

1

ovarian cancer

Official Title

RET

2

ovarian cancer

Outcome Measure

Fibroblast Growth Factor (FGF2)

1

pancreatic cancer

Detailed Description

HER2/ERBB2

1

pancreatic cancer

Eligibility Criteria

SERPINA2

ring finger protein 2

RAD51

partner and localizer of BRCA2

Nuclear protein Ki67

methylmalonic aciduria (cobalamin deficiency) cblB type

membrane associated guanylate kinase, WW and PDZ domain containing 1

HER2/ERBB2

FANCA

CHK2

BRCA2

BRCA1 interacting protein C-terminal helicase 1

BRCA1

BAP1

ATR

Ataxia telangiectasia mutated

anthrax toxin receptor 1

1

1

1

1

1

1

1

2

1

1

1

1

1

1

1

1

1

paraganglioma

Eligibility Criteria

von Hippel-Lindau tumor suppressor, E3 ubiquitin protein ligase

1

peripheral T-cell lymphoma

Arm Group Description

RET

1

peritoneal cancer

Eligibility Criteria

PD-L2

PD-1/CD279

PARP-1

Estrogen receptor alpha (ER alpha)

cytotoxic T-lymphocyte-associated protein 4

collagen, type XI, alpha 2

1

1

1

1

1

1

peritoneal cancer

Official Title

RET

2

peritoneal cancer

Outcome Measure

Fibroblast Growth Factor (FGF2)

1

Phaeochromocytoma

Eligibility Criteria

von Hippel-Lindau tumor suppressor, E3 ubiquitin protein ligase

1

rectal cancer

Outcome Measure

CD95 (APO-1/Fas)

1

rectal cancer

Brief Title

BRAF

1

rectal cancer

Detailed Description

RAS

BRAF

1

1

rectal cancer

Eligibility Criteria

RAS

BRAF

1

1

rectal cancer

Official Title

BRAF

1

rectal cancer

Brief Summary

RAS

BRAF

1

1

renal cell carcinoma

Arm Group Label

Maleic acid

1

small cell lung cancer

Brief Summary

C-Kit

1

small cell lung cancer

Detailed Description

Fibroblast growth factor receptor 1 (FGFR1)

1

small cell lung cancer

Eligibility Criteria

T-cell surface antigen CD4

Luteinizing hormone (LH)

FSH

Epidermal growth factor receptor (EGFR)

Anaplastic lymphoma receptor tyrosine kinase (ALP)

1

1

1

2

2

soft tissue sarcoma

Brief Summary

FLT4

1

soft tissue sarcoma

Eligibility Criteria

T-cell surface antigen CD4

p63

Alkaline phosphatase (ALPL)

1

1

2

solid tumours

Arm Group Label

PD-L1/CD274

Fibroblast growth factor receptor 4 (FGFR4)

Fibroblast growth factor receptor 3 (FGFR3)

Fibroblast growth factor receptor 2 (FGFR2)

Fibroblast growth factor receptor 1 (FGFR1)

1

1

1

1

1

solid tumours

Brief Title

Microsatellite Instable (MSI)

Fibroblast growth factor receptor 4 (FGFR4)

Fibroblast growth factor receptor 3 (FGFR3)

Fibroblast growth factor receptor 2 (FGFR2)

Fibroblast growth factor receptor 1 (FGFR1)

1

1

1

1

1

solid tumours

Detailed Description

HER2/ERBB2

1

solid tumours

Eligibility Criteria

T-cell surface antigen CD4

SERPINA2

ring finger protein 2

RAD51

partner and localizer of BRCA2

methylmalonic aciduria (cobalamin deficiency) cblB type

membrane associated guanylate kinase, WW and PDZ domain containing 1

HER2/ERBB2

Fibroblast growth factor receptor 4 (FGFR4)

Fibroblast growth factor receptor 3 (FGFR3)

Fibroblast growth factor receptor 2 (FGFR2)

Fibroblast growth factor receptor 1 (FGFR1)

FANCA

CHK2

BRCA2

BRCA1 interacting protein C-terminal helicase 1

BRCA1

BAP1

ATR

Ataxia telangiectasia mutated

anthrax toxin receptor 1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

solid tumours

Official Title

PD-L1/CD274

Microsatellite Instable (MSI)

Fibroblast growth factor receptor 4 (FGFR4)

Fibroblast growth factor receptor 3 (FGFR3)

Fibroblast growth factor receptor 2 (FGFR2)

Fibroblast growth factor receptor 1 (FGFR1)

1

1

1

1

1

1

solid tumours

Brief Summary

Fibroblast growth factor receptor 4 (FGFR4)

Fibroblast growth factor receptor 3 (FGFR3)

Fibroblast growth factor receptor 2 (FGFR2)

Fibroblast growth factor receptor 1 (FGFR1)

1

1

1

1

squamous cell cancer

Brief Title

PD-L1/CD274

1

squamous cell cancer

Detailed Description

Epidermal growth factor receptor (EGFR)

1

squamous cell cancer

Eligibility Criteria

tumor necrosis factor receptor superfamily, member 4

tumor necrosis factor receptor superfamily member 9

ROS1

PD-L2

PD-L1/CD274

PD-1/CD279

PARP-1

Luteinizing hormone (LH)

FSH

Epidermal growth factor receptor (EGFR)

cytotoxic T-lymphocyte-associated protein 4

collagen, type XI, alpha 2

Anaplastic lymphoma receptor tyrosine kinase (ALP)

1

1

5

1

2

1

1

1

1

9

2

1

9

squamous cell cancer

Official Title

RET

PD-L1/CD274

1

1

squamous cell cancer

Brief Summary

Epidermal growth factor receptor (EGFR)

C-Kit

1

1

synovial sarcoma

Brief Summary

FLT4

1

synovial sarcoma

Eligibility Criteria

p63

Alkaline phosphatase (ALPL)

1

1

T-cell lymphoma

Eligibility Criteria

Fibrinogen

Creatinine

Bilirubin

ALT

1

1

1

1

T-cell lymphoma

Official Title

ASRGL1

1

thyroid cancer

Brief Summary

FLT4

1

urogenital cancer

Eligibility Criteria

HER2/ERBB2

1

Biomarker

Drug Name Biomarker Name Biomarker Function
Catequentinib - Advenchen Laboratories/Jiangsu Chia Tai Tianqing Pharmaceutical ADAM metallopeptidase domain 17 Arm Group Description, Arm Group Label, Brief Title, Eligibility Criteria, Official Title
Adenosine diphosphate ribose Eligibility Criteria
Alkaline phosphatase (ALPL) Arm Group Description, Eligibility Criteria
Alpha-fetoprotein (AFP) Eligibility Criteria, Outcome Measure
ALT Eligibility Criteria
Anaplastic lymphoma receptor tyrosine kinase (ALP) Brief Summary, Detailed Description, Eligibility Criteria
anthrax toxin receptor 1 Eligibility Criteria
ASRGL1 Official Title
Ataxia telangiectasia mutated Eligibility Criteria
ATR Eligibility Criteria
BAP1 Eligibility Criteria
Bilirubin Eligibility Criteria
BRAF Brief Summary, Brief Title, Detailed Description, Eligibility Criteria, Official Title
BRCA1 Eligibility Criteria
BRCA1 interacting protein C-terminal helicase 1 Eligibility Criteria
BRCA2 Eligibility Criteria
C-Kit Brief Summary, Detailed Description
CALCA Eligibility Criteria
carcinoembryonic antigen related cell adhesion molecule 3 Eligibility Criteria
CD3 gamma chain (CD3G) Outcome Measure
CD95 (APO-1/Fas) Outcome Measure
CEA Eligibility Criteria
CHK2 Eligibility Criteria
Chordoma Brief Title, Official Title
COL18A1 Arm Group Description
collagen, type XI, alpha 2 Eligibility Criteria
Creatinine Eligibility Criteria
Cytokeratin 18 Eligibility Criteria
cytokine inducible SH2-containing protein Eligibility Criteria
cytotoxic T-lymphocyte-associated protein 4 Eligibility Criteria, Official Title, Outcome Measure
Down syndrome chromosome region Outcome Measure
Epidermal growth factor receptor (EGFR) Arm Group Description, Arm Group Label, Brief Summary, Brief Title, Detailed Description, Eligibility Criteria, Official Title, Outcome Measure
Estrogen receptor alpha (ER alpha) Eligibility Criteria
FANCA Eligibility Criteria
Fibrinogen Eligibility Criteria
Fibroblast Growth Factor (FGF2) Brief Summary, Outcome Measure
Fibroblast growth factor receptor 1 (FGFR1) Arm Group Label, Brief Summary, Brief Title, Detailed Description, Eligibility Criteria, Official Title
Fibroblast growth factor receptor 2 (FGFR2) Arm Group Label, Brief Summary, Brief Title, Detailed Description, Eligibility Criteria, Official Title
Fibroblast growth factor receptor 3 (FGFR3) Arm Group Label, Brief Summary, Brief Title, Eligibility Criteria, Official Title
Fibroblast growth factor receptor 4 (FGFR4) Arm Group Label, Brief Summary, Brief Title, Eligibility Criteria, Official Title
FLT4 Brief Summary
FSH Eligibility Criteria
HAVCR2 (TIM-3) Outcome Measure
HER2/ERBB2 Brief Summary, Brief Title, Detailed Description, Eligibility Criteria, Official Title
Hydrocortisone Eligibility Criteria
IDH1 Eligibility Criteria
Interleukin-6 (IL-6) Outcome Measure
KRAS Brief Title, Eligibility Criteria, Official Title
L-Aspartic acid Eligibility Criteria
LAG-3 (CD223) Outcome Measure
Luteinizing hormone (LH) Eligibility Criteria
Maleic acid Arm Group Label
Mannitol Eligibility Criteria
mannose receptor, C type 1 Eligibility Criteria
membrane associated guanylate kinase, WW and PDZ domain containing 1 Eligibility Criteria
methylmalonic aciduria (cobalamin deficiency) cblB type Eligibility Criteria
MGMT Arm Group Description, Brief Summary, Brief Title, Detailed Description, Eligibility Criteria, Official Title
Microsatellite Instable (MSI) Brief Title, Eligibility Criteria, Official Title
N-acylethanolamine acid amidase Eligibility Criteria
N-Myc Brief Summary
Nuclear protein Ki67 Eligibility Criteria, Outcome Measure
Oxalacetic acid Eligibility Criteria
p63 Eligibility Criteria
PARP-1 Eligibility Criteria
partner and localizer of BRCA2 Eligibility Criteria
PD-1/CD279 Eligibility Criteria, Official Title, Outcome Measure
PD-L1/CD274 Arm Group Description, Arm Group Label, Brief Summary, Brief Title, Eligibility Criteria, Official Title, Outcome Measure
PD-L2 Eligibility Criteria, Outcome Measure
PDGFRA Brief Summary, Detailed Description, Eligibility Criteria
PDGFRB Brief Summary, Detailed Description, Eligibility Criteria
PGR Eligibility Criteria
PLK3 Brief Summary
pregnancy specific beta-1-glycoprotein 2 Eligibility Criteria
Progesterone Eligibility Criteria
Prothrombin (PT) Eligibility Criteria
RAD51 Eligibility Criteria
RAS Brief Summary, Detailed Description, Eligibility Criteria
RET Arm Group Description, Official Title
ring finger protein 2 Eligibility Criteria
ROS1 Brief Summary, Brief Title, Detailed Description, Eligibility Criteria, Official Title
SERPINA2 Eligibility Criteria
T-Cell differentiation antigen CD8 Outcome Measure
T-cell receptor CD3-epsilon (CD3e) Outcome Measure
T-cell receptor T3 delta chain (CD3d) Outcome Measure
T-cell surface antigen CD4 Eligibility Criteria, Outcome Measure
Thyroid stimulating hormone beta (TSH) Eligibility Criteria
Thyroxine (T4) Eligibility Criteria
Tumor Mutational Burden Brief Summary, Outcome Measure
tumor necrosis factor receptor superfamily, member 4 Eligibility Criteria
VEGFR Brief Summary, Detailed Description, Eligibility Criteria
von Hippel-Lindau tumor suppressor, E3 ubiquitin protein ligase Eligibility Criteria
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Development Status

Summary Table

Indication Qualifier Patient Segment Phase Countries Route / Formulation Developers Event Date
Acral lentiginous melanoma in combination with TQB 2450 Combination therapy, Late-stage disease, Second-line therapy or greater Phase I/II China PO / Capsule Chia Tai Tianqing Pharmaceutical Group 11 Jun 2019
Alveolar soft part sarcoma - Inoperable/Unresectable, Late-stage disease, Metastatic disease Phase III Italy, USA PO / Capsule Advenchen Laboratories 15 Aug 2017
Bone cancer - In adolescents, In adults, In the elderly, Metastatic disease, Recurrent, Second-line therapy or greater Phase II China PO / Capsule Chia Tai Tianqing Pharmaceutical Group 31 Jan 2018
Breast cancer - Combination therapy, Metastatic disease, Second-line therapy or greater Phase I China PO / Capsule Chia Tai Tianqing Pharmaceutical Group 09 May 2019
Cancer - Late-stage disease, Second-line therapy or greater Phase II China PO / Capsule Chia Tai Tianqing Pharmaceutical Group 01 Aug 2013
Cervical cancer - Adjunctive treatment, Metastatic disease, Recurrent, Second-line therapy or greater Phase I/II USA PO / unspecified Advenchen Laboratories 01 Dec 2015
Cervical cancer - Metastatic disease, Recurrent, Second-line therapy or greater Phase I/II USA PO / unspecified Advenchen Laboratories 01 Nov 2015
Cholangiocarcinoma in combination with penpulimab Combination therapy, Inoperable/Unresectable, Metastatic disease, Second-line therapy or greater Phase II China PO / Capsule Chia Tai Tianqing Pharmaceutical Group 03 Jun 2020
Colorectal cancer - Combination therapy, First-line therapy, Inoperable/Unresectable, Metastatic disease Phase III China PO / Capsule Chia Tai Tianqing Pharmaceutical Group 27 May 2021
Colorectal cancer - Late-stage disease, Metastatic disease, Second-line therapy or greater Phase III China PO / Capsule Chia Tai Tianqing Pharmaceutical Group 20 Jul 2016
Colorectal cancer in combination with penpulimab Combination therapy, Inoperable/Unresectable, Metastatic disease, Recurrent Phase II China PO / Capsule Chia Tai Tianqing Pharmaceutical Group 03 Jun 2020
Endometrial cancer - Adjunctive treatment, Metastatic disease, Recurrent, Second-line therapy or greater Phase I/II USA PO / unspecified Advenchen Laboratories 01 Dec 2015
Endometrial cancer - Metastatic disease, Recurrent, Second-line therapy or greater Phase I/II USA PO / unspecified Advenchen Laboratories 01 Nov 2015
Ewing's sarcoma - Late-stage disease, Second-line therapy or greater Phase II China PO / Capsule Peking University People's Hospital 22 Jan 2018
Fallopian tube cancer in combination with niraparib Combination therapy, Recurrent, Second-line therapy or greater Phase II China PO / unspecified Chia Tai Tianqing Pharmaceutical Group 12 Mar 2020
Fallopian tube cancer - Late-stage disease, Second-line therapy or greater Phase II China PO / unspecified Chia Tai Tianqing Pharmaceutical Group 01 Mar 2019
Fallopian tube cancer - Adjunctive treatment, Metastatic disease, Recurrent, Second-line therapy or greater Phase I/II USA PO / unspecified Advenchen Laboratories 01 Dec 2015
Gastric cancer - - Phase III China PO / Capsule Chia Tai Tianqing Pharmaceutical Group 20 Jul 2016
Gastric cancer in combination with penpulimab Combination therapy, Metastatic disease, Recurrent Phase II China PO / Capsule Chia Tai Tianqing Pharmaceutical Group 03 Jun 2020
Gastrointestinal stromal tumours - Late-stage disease, Metastatic disease, Recurrent, Second-line therapy or greater Phase II China PO / unspecified Chia Tai Tianqing Pharmaceutical Group 23 Oct 2018
Glioblastoma AK105 With Anlotinib and Radiotherapy Adjuvant Therapy Adjuvant therapy, First-line therapy, Newly diagnosed Phase II China PO / Capsule Chia Tai Tianqing Pharmaceutical Group 05 Sep 2021
Glioblastoma - Late-stage disease Phase II China PO / Capsule Chia Tai Tianqing Pharmaceutical Group 13 Apr 2021
Head and neck cancer - Combination therapy, Late-stage disease, Metastatic disease, Recurrent, Second-line therapy or greater Phase II China PO / Capsule Chia Tai Tianqing Pharmaceutical Group 09 May 2020
Leiomyosarcoma - Inoperable/Unresectable, Late-stage disease, Metastatic disease, Recurrent Phase III Italy, USA PO / Capsule Advenchen Laboratories 15 Aug 2017
Liver cancer - Combination therapy, First-line therapy, Inoperable/Unresectable Phase II China PO / unspecified Akeso Biopharma 22 Nov 2018
Liver cancer - - Phase II China PO / unspecified Chia Tai Tianqing Pharmaceutical Group 01 Sep 2016
Nasopharyngeal cancer - Combination therapy, First-line therapy, Late-stage disease, Metastatic disease, Recurrent Phase III China PO / Capsule Chia Tai Tianqing Pharmaceutical Group 02 Sep 2018
Neuroendocrine tumours Gastroenteropancreatic neuroendocrine tumour In adults, In the elderly, Inoperable/Unresectable, Late-stage disease, Metastatic disease, Second-line therapy or greater Phase II China PO / Capsule Chia Tai Tianqing Pharmaceutical Group 30 Jan 2018
Neuroendocrine tumours in combination with penpulimab Combination therapy, Late-stage disease Phase II China PO / Capsule Chia Tai Tianqing Pharmaceutical Group 03 Jun 2020
Non-small cell lung cancer - Late-stage disease, Metastatic disease, Second-line therapy or greater Marketed China PO / Capsule Chia Tai Tianqing Pharmaceutical Group 11 May 2018
Non-small cell lung cancer in combination with platinum plus pemetrexed Combination therapy, Late-stage disease, Metastatic disease, Second-line therapy or greater Phase III China PO / Capsule Chia Tai Tianqing Pharmaceutical Group 08 Aug 2019
Non-small cell lung cancer in combination with TQB2450, as consolidation treatment Combination therapy, Inoperable/Unresectable, Late-stage disease, Monotherapy, Second-line therapy or greater Phase III China PO / Capsule Chia Tai Tianqing Pharmaceutical Group 30 Mar 2020
Non-small cell lung cancer In combination with Pemetrexed and Carboplatin Combination therapy, First-line therapy, Late-stage disease, Locally recurrent Phase I China PO / unspecified Chia Tai Tianqing Pharmaceutical Group 22 Mar 2019
Ovarian cancer in combination with niraparib Combination therapy, Recurrent, Second-line therapy or greater Phase II China PO / unspecified Chia Tai Tianqing Pharmaceutical Group 12 Mar 2020
Ovarian cancer - Second-line therapy or greater Phase II China PO / unspecified Chia Tai Tianqing Pharmaceutical Group 01 Mar 2019
Ovarian cancer - Adjunctive treatment, Metastatic disease, Recurrent, Second-line therapy or greater Phase I/II USA PO / unspecified Advenchen Laboratories 01 Dec 2015
Ovarian cancer - Metastatic disease, Recurrent, Second-line therapy or greater Phase I/II USA PO / unspecified Advenchen Laboratories 01 Nov 2015
Peritoneal cancer - Late-stage disease, Second-line therapy or greater Phase II China PO / unspecified Chia Tai Tianqing Pharmaceutical Group 01 Mar 2019
Peritoneal cancer in combination with niraparib Combination therapy, Recurrent, Second-line therapy or greater Phase II China PO / unspecified Chia Tai Tianqing Pharmaceutical Group 12 Mar 2020
Peritoneal cancer - Adjunctive treatment, Metastatic disease, Recurrent, Second-line therapy or greater Phase I/II USA PO / unspecified Advenchen Laboratories 01 Dec 2015
Renal cell carcinoma - Late-stage disease, Second-line therapy or greater Phase II China PO / Capsule Chia Tai Tianqing Pharmaceutical Group 01 Dec 2013
Small cell lung cancer - Late-stage disease, Second-line therapy or greater Phase II China PO / unspecified Chia Tai Tianqing Pharmaceutical Group 01 Mar 2017
Small cell lung cancer - Combination therapy, First-line therapy, Late-stage disease Phase II China PO / unspecified Tianquan Pharmaceutical 15 Jan 2019
Soft tissue sarcoma - Late-stage disease, Second-line therapy or greater Phase II China PO / Capsule Chia Tai Tianqing Pharmaceutical Group 01 Apr 2013
Solid tumours in combination with TQB 2450 Combination therapy, Late-stage disease, Metastatic disease Phase I China PO / Capsule Chia Tai Tianqing Pharmaceutical Group 20 Jun 2019
Squamous cell cancer oesophageal squamous cell carcinoma Late-stage disease, Metastatic disease, Second-line therapy or greater Phase II China PO / unspecified Chia Tai Tianqing Pharmaceutical Group 01 Jan 2016
Squamous cell cancer oesophageal squamous cell carcinoma Combination therapy, First-line therapy, Late-stage disease Phase II China PO / unspecified Chia Tai Tianqing Pharmaceutical Group, Henan Cancer Hospital 07 Oct 2019
Synovial sarcoma - Inoperable/Unresectable, Late-stage disease, Metastatic disease, Recurrent Phase III Italy, USA PO / Capsule Advenchen Laboratories 15 Aug 2017
Thyroid cancer in patients with differentiated thyroid cancer - Phase III China PO / Capsule Chia Tai Tianqing Pharmaceutical Group 20 Jul 2016
Thyroid cancer in patients with medullary thyroid carcinoma Late-stage disease Phase III China PO / Capsule Chia Tai Tianqing Pharmaceutical Group 20 Jul 2016
Urogenital cancer in combination with penpulimab Combination therapy, Inoperable/Unresectable, Late-stage disease, Metastatic disease Phase II China PO / Capsule Chia Tai Tianqing Pharmaceutical Group 03 Jun 2020

Orphan Status

Indication Patient Segment Country Organisation Event Date
Ovarian cancer - USA Advenchen Laboratories 01 Jan 2015

Commercial Information

Involved Organisations

Organisation Involvement Countries
Jiangsu Chia-Tai Tianqing Pharmaceutical Originator China
Advenchen Laboratories Originator USA
Jiangsu Chia-Tai Tianqing Pharmaceutical Owner China
Advenchen Laboratories Owner USA
Nanjing University Collaborator China
Henan Cancer Hospital Collaborator China
Akeso Biopharma Collaborator China
Peking University People's Hospital Collaborator China
Chia Tai Tianqing Pharmaceutical Group Collaborator China
Tianquan Pharmaceutical Collaborator China

Brand Names

Brand Name Organisations Indications Countries
FOCUS V Chia Tai Tianqing Pharmaceutical Group Non-small cell lung cancer China

Scientific Summary

Pharmacokinetics

Phase I/II:

In a part I of a phase I/II trial, treatment with catequentinib (12mg) in patients with ovarian (n=1) and endometrial (n=2) cancer, demonstrated the average drug concentration peak time (tmax) as 10 (4.24) hrs and the average max drug blood concentration (cmax) as 9.60 (8.47-11.50) ng/mL. The average tmax reported was 360 hrs (15 days) and the average cmax was 63.80 (52.90-80.30) ng/mL, after multiple, continuous dosing. The trial enrolled 3 patients [79] [78] .

Adverse Events

Phase III

Grade ≥ 3 treatment-related adverse events including hypertension (13.61%, p < 0.0001), dermal toxicity (3.74%, p = 0.019) and hypertriglyceridemia (3.06%, p = 0.034) were observed in patients with advanced non-small cell lung cancer (n = 294), when treated with 12 mg catequentinib, once-daily orally. There were no treatment–related deaths. The randomised, placebo-controlled, double blind phase III ALTER0303 trial enrolled 439 patients [5] [7] .

Phase II/III

Results from the phase II/III trial in patients with medullary thyroid carcinoma showed that catequentinib was well tolerated with a consistent safety profile and no new adverse events. All patients in the catequentinib arm experienced adverse events following treatment compared with 89.66% of patients in placebo arm. Hand-foot syndrome, hypertension, hypertriglyceridaemia and diarrhoea were the most common AEs reported among patients in the catequentinib arm. The trial enrolled 91 patients [40] [41] .

Results from the phase II/III ALTER01032 trial in patients with differenciated thyroid cancer showed that the incidence of treatment-related AEs (TRAEs) in catequentinib and placebo arms was 100% and 86.49%, respectively. About 15.79% in the catequentinib arm experienced serious TRAEs. The most common TRAEs in catequentinib arm included hypertension (84.21%) and hand-foot syndrome (73.68%). The trial enrolled 113 patients [39] [38] .

Data from one of multi-centers in the phase IIb ALTER0203 trial (n = 48) showed that hypertension, elevated TSH, hypertriglyceridaemia as the most common adverse events (AEs). The most common Grade ≥3 AEs were menstrual disorder, hypertension, gamma glutamyl transferase elevation, hand-foot syndrome, hypertriglyceridemia and lipase elevation. The randomised 2:1, double-blind and placebo-controlled phase IIb/III trial is designed to assess the safety and efficacy of catequentinib in 233 patients with soft tissue sarcoma [27] [28] .

Phase I/II:

In a part I of a phase I/II trial, treatment with catequentinib was safe and well tolerated, in patients with ovarian (n=1) and endometrial (n=2) cancer with no dose-limiting toxicities in cycle 1. Grade 1 and 2 treatment emergent adverse events were reported, which includes hypertension (htn), oral pain, epistaxis, pain, insomnia, headache, fatigue, tinnitus, sinus tachycardia, anorexia, fatigue, urinary tract infection and urinary frequency. No significant safety concerns were reported. One patient experienced grade 2 htn and one patient experienced grade 3 htn on C2D2 [79] [78] .

In the phase II, ALTER0802 study, treatment related AEs (TRAEs) were limited to mild hypertention, hand-foot skin reaction and bone and muscular pain. No grade IV or above AEs occurred [71] [72] .

Results from a phase I/II clinical trial of anlotinib in combination with TQB 2450 in patients with EGFR+ advanced non-small scale lung cancer demonstrated favorable safety profile. Among 18 evaluated patients, most frequent TRAE included hypertension (27.8%), hand and foot skin reaction (22.2%) and proteinuria (16.7%). Grade 3 TRAE occurred in 16.7% patients (3/18 pts), all were hypertension, and no Grade 4/5 TRAE were observed. Dose delay due to TRAE occurred in 22.2% patients while no one discontinued treatment due to TRAE. The dose escalation cohort included 9 patients, no dose limiting toxicity occurred [16] [15] .

Results from a phase I/II trial in ovarian cancer at data cutoff date 15 Jan 2021 showed treatment-related grade 3 or 4 adverse events (AEs) in 54.5% patients, and the most common ones were palmar-plantar erythrodysesthesia syndrome (21.2%) and hypertension (18.2%). The most potential immune-related AEs included grade 1 to 2 hypothyroidism (24.2%) and fatigue (9.1%). No treatment-related death was recorded [76] [77]

In a phase Ib/II trial, cadonilimab (AK 104) in combination with catequentinib (anlotinib) demonstrated an acceptable safety profile in treatment-naïve patients with PD-L1 tumour proportion score (TPS) = 1% non-small cell lung cancer (NSCLC). Grade 3 treatment-related adverse events (TRAEs) occurred in 6% (1/18, 1 proteinuria) of patients. No Grade 4 or 5 TRAEs were reported. The results were obtained from 18 treatment-naïve NSCLC patients, squamous/non-squamous with PD-L1 TPS ≥1% ho received combination therapy (2 received 10 mg/kg AK 104, 16 received 15 mg/kg AK 104; and all received 12 mg anlotinib) in part 1 of the trial [13] [14] .

Phase II: Results from the phase II trial showed that catequentinib in patients with relapsed or metastatic primary malignant bone tumor had acceptable toxicity. Most common Gr 3-5 catequentinib-related AEs were hypertension (19.05%), hypertriglyceridemia (9.52%), hand-foot syndrome (7.14%), and proteinuria (4.76%). The open label trial evaluated the safety and efficacy of catequentinib hydrochloride capsule in patients with primary malignant bone tumours with recurrence and distant metastases [64] [65] .

In a phase II trial in oesophageal squamous cell carcinoma patients (n=34) of paclitaxel and cisplatin combined with anlotinib, the common drug-related adverse events were myelosuppression, gastrointestinal reaction, fatigue, hypertension, constipation, hypokalaemia, hepatotoxicity and hemoptysis. And the common grade ≥3 adverse events were myelosuppression (20.6%), hypertension (8.8%), nausea and vomit (5.9%), fatigue (5.9%) and hypokalaemia (5.9%) [37] [36] .

In a phase II trial in patients with ovarian cancer (n=31) of catequentinib, most of the occurring adverse events (AEs) were grade 1 and grade 2, and =10% grade 1 AEs included hypertension (41.94%), fatigue (22.58%), and hand-foot syndrome (29.03%). Grade 2 AEs included gingival bleeding (4.76%), hand-foot syndrome (4.76%), renal dysfunction (4.76%) and cancer pain (4.76%). Grade 3 AEs only included myocardial infarction (4.76%) and urine occult blood (4.76%). No higher-grade AEs were observed. Neither unexpected safety signals nor treatment related death occurred [62] [60] .

Results of the open-label phase II trial of penpulimab, in combination with anlotinib hydrochloride demonstrated manageable safety profile in 25 evaluable patients with unresectable hepatocellular carcinoma. Treatment-related adverse events (TRAEs) occurred in 93.5% of patients (G3 in 9.7% [3/31], no G4, and leading to treatment discontinuation in 6.5% [2/31]). Most frequent TRAEs were increased AST (35.5%), increased ALT (29%), asthenia (22.6%), decreased platelet count (19.4%), increased blood bilirubin (19.4%), increased bilirubin conjugated (19.4%), and rash (16.1%) [58] [57] .

In phase I trial in patients with recurrent high grade glioma, catequentinib was well tolerated (n=12). Most adverse events were grade 1 or 2. Grade 3 adverse events occurred in 3 out of 12 patients. These included seizures, neutropenia, leukopenia, respectively. A death was reported due to intracranial hemorrhage during the treatment [31] [30] .

Phase I:

Result from a phase I trial demonstrated that anlotinib combined with pemetrexed and carboplatin in non-small cell lung cancer was well tolerated, and the AEs were manageable. The most common grade ≥ 3 AEs were hypertension 22.2%, neutropenia 19.44%, myelosuppression 11.1%, thrombocytopenia 8.33%, leukopenia 5.56%, hand-foot syndrome 5.56% and there were no Grade 5 toxicities [20] [19] .

Small cell lung cancer:

In the phase II ALTER1202 trial in patients with advanced small cell lung cancer, treatment with catequentinib was safe and well tolerated. The most common adverse events in catequentinib group were hypertension (37.04%), fatigue (29.63%) and loss of appetite (29.63%) while in placebo group were γ- glutamyl transferase elevation (20.00%) and loss of appetite (20.00 %) [68] [67] .

In a phase I trial in breast cancer patients (n = 34) TQB 2450 plus anlotinib showed an acceptable safety profile. Seventeen patients experienced grade 3 treatment-related AEs (TRAEs). Most frequently occurring (>5%) grade 3 TRAEs were QT interval prolongation (17.65%), hypertension (14.71%), diarrhoea (8.82%), hand-foot syndrome (HFS) (8.82%), and hypertriglyceridaemia (5.88%). In the dose-escalation phase, three patients receiving 10mg anlotinib plus 1200mg TQB 2450 had no dose-limiting toxicities (DLTs) in the first cycle, neither did three patients with 12mg anlotinib plus TQB 2450 [86] [21] .

No new or unexpected safety signals were reported in phase II trial in patients with ovarian cancer. Grade 1 adverse events included hypertention (45.83%), fatigue (29.17%), hand-foot syndrome (33.33%) and hoarseness (12.50%). Grade 2 adverse events included gingival bleeding (4.2%), hand-foot syndrome (4.2%), renal dysfunction (4.2%) and cancer pain (4.2%) [61] . Earlier results from the trial, treatment with catequentinib in combination with peremetex was found to safe and well tolerated. Any grades of adverse events (AEs) were observed in 92.6% (25/27) of patients, containing allergic eruption (33.3%), hand-foot syndrome (29.6%), hypertension (25.9%), and fatigue (25.9%). The grade 3-4 adverse events were only observed in 5 patients, including 1 with grade 3 proteinuria, 1 with grade 3 ascites, 1 with grade 3 fatigue, 1 with grade 3 edema limbs and 1 with grade 4 anemia [59] [60] .

In a phase III trial, treatment with catequentinib was found to be safe. For grade 3 treatment-related adverse events, 12 (23.1%) of patients experienced for catequentinib and 7 (25.9%) of patients experienced for dacarbazine. The most common catequentinib related grade 3 AEs were diarrhea (5.8%) and hypertension (3.8%) [25] [24] .

In a phase II trial, penpulimab [see Adis Insight drug profile 800050249] plus catequentinib showed an acceptable safety profile in patients with advanced head, neck and chest cancer. In updated results, treatment-related adverse events (TRAEs) were reported in 93.3% patients. The ≥ grade 3 TRAEs occurred in 36.7% patients in which the most common ≥ grade 3 TRAEs included hypothyroidism (6.7%) and hypertension (6.7%). The data were reported from 30 patients who were enrolled and treated between 10 June 2020 to 16 April 2021. In earlier reported data, Grade 3 treatment-related adverse events (TRAEs) occurred in 30% (6/20, 2 hypertension, 1 hypertriglyceridaemia, 1 gamma-glutamyltransferase increased, 1 palmar-plantar erythrodysaesthesia syndrome and 1 hyponatraemia) of patients. No Grade 4 or 5 TRAEs had observed [52] [51] [50] .

Pharmacodynamics

Summary

Sub-analysis of the randomised, placebo-controlled, phase IIb/III ALTER01031 trial in patients with medullary thyroid carcinoma observed that catequentinib highly decreased serum calcitonin (Ct). At baseline, 86 of 91 enrolled patients (58 in catequentinib arm and 28 in placebo arm) were recorded their serum Ct levels and no significant difference was observed between two arms (7990.0 ng/L versus 10891.5 ng/L, P = 0.192). After two treatment cycles, the Ct level decreased to 4597.5 ng/L in catequentinib arm (n = 50) while increased slightly in placebo arm (12640.0 ng/L, n = 24, P = 0.006). For 49 patients in catequentinib arm who had complete assessments at baseline and week 6, roughly linear relationship was observed between Ct levels (X-axis) and target lesion diameters (Y-axis) in percent changes from baseline to week 6 (y = 0.175x – 0.049; r = 0.352, P = 0.016, excluding 3 outliers). Patients with less baseline Ct level (≤ median value vs. > median value) did not show more PFS benefit (17.7 versus 22.4 months, P = 0.802). However, after two treatment cycles, a trend of better survival and higher response was observed in patients with high percentage decline of Ct level (> 50%, n = 25) than those with low percentage decline (≤50%, n = 25) although without statistical difference [42] [41] .

Therapeutic Trials

Phase III:

Treatment with 12 mg catequentinib, once-daily orally, in patients with advanced non-small cell lung cancer (NSCLC), resulted in 66.82% overall survival (OS). An OS of 9.63 months was observed in catequentinib-treated arm (95% CI: 8.17, 10.60, n = 294), compared to 6.30 months with placebo treatment (95% CI: 5.00, 8.10, n = 143) [HR = 0.68 (95% CI: 0.54, 0.87), p = 0.0018]. Progression-free survival of 5.37 months was seen with catequentinib treatment (95% CI: 4.40, 5.63), compared to 1.40 months with placebo (95% CI: 1.07, 1.50) [HR = 0.25 (95% CI: 0.19, 0.31) p < 0.0001]. The catequentinib-treated arm showed an objective response rate (complete response + partial response) of 9.18% and disease control rate (complete response + partial response + stable disease) of 80.95%, compared to 0.7% and 37.06% in the placebo-arm, respectively (p < 0.0001). The randomised, double blind phase III ALTER0303 trial enrolled 439 patients [5] [7] .

In a phase III trial, treatment with catequentinib demonstrated improved disease control and superior progression free survival for catequentinib vs dacarbazine in advanced synovial sarcoma. Overall, PFS was 2.89 months (95% CI: 2.73 – 6.87) for catequentinib and 1.64 (95% CI: 1.45 – 2.70) for D. The PFS of study met the primary endpoint with a p-value of 0.0015 and a HR of 0.449 (95% CI: 0.270– 0.744). At the month 4, 6, and 12, the percentages of progression free patients for catequentinib were 48.1%, 42.3% and 26.9%; and for dacarbazinewere 14.85%, 11.1% and 3.7% [25] [24] .

Phase II

Updated results from the phase II ALTER1202 trial in patients with advanced small cell lung cancer, catequentinib significantly improved progress-free survival (PFS) (2.83 vs. 0.69 months; HR =0.10; 95% CI, 0.03–0.28; P0.0001) compared to placebo and prolonged the overall suirval (OS) of 3.75 months without statistical significance (6.51 vs. 2.76 months; HR = 0.52; 95% CI, 0.22–1.23; P =0.1285) compared to placebo. The objective response rate was 3.85% in the catequentinib group and 0% in the placebo group (P =0.442). Stable disease was reported in 16(61.54%) patients in the catequentinib group and no patient in the placebo group. The disease control rate was significantly higher in the catequentinib group (65.38%) than in the placebo group (0, P =0.000043). There was no complete response in either group [68] . Earlier, results from the phase II ALTER 1202 trial showed that catequentinib significantly prolonged both progression free survival (PFS) and overall survival (OS) compared with placebo. In the catequentinib arm, the median OS was significantly prolonged by about 2.4 months compared versus placebo (7.3 months vs 4.9 months). The number of events of OS were reported to be 60 and 33 in the catequentinib arm and placebo arm, respectively (HR 0.53, 95%CI 0.3-0.8; p = 0.0029). In the catequentinib group the rates of six-month and one year survival were 63.9% and 30.6% compared with 32.7% and 13.1% in the placebo group. A favorable hazard ratio for OS was reported for catequentinib in most subgroups, especially for patients with brain metastases (OS: 6.3m vs 2.6m; HR 0.23, 95% CI 0.09-0.59; p = 0.0009) and patients who received study drug as third-line therapy (OS: 7.3m vs 4.9m; HR 0.50, 95%CI 0.31-0.82; p = 0.0051). The trial enrolled 120 patients [66] [67] .

Results from the phase II trial (n=42 efficacy-evaluable patients; 29 patients of osteosarcoma, 9 patients of chondrosarcoma, 3 patients of ewing sarcoma and 1 patient of bone derived malignant fibrous histiocytoma) showed that the progression-free rate at 12 weeks (PFR12weeks), ORR and DCR were 71.3%, 9.52% and 78.57%. Median PFS was 5.26 months (95%CI = 3.48-8.44). Median OS was 11.40 months (95%CI = 10.09, [ ). Median PFS of osteosarcoma and chondrosarcoma was 4.83 months (95%CI = 3.48, 7.13 ) and 2.76 months (95%CI = 1.31, [ ) respectively. The open label trial evaluated the safety and efficacy of catequentinib capsule in patients with primary malignant bone tumours with recurrence and distant metastases [64] [65] .

In a phase II trial in patients with ovarian cancer (n=27) of catequentinib, incidence of complete response, partial response, stable disease and progressive disease was 3.7%, 22.22%, 40.74% and 33.33%, respectively, yielding the ORR of 25.9% (7/27; 95% CI: 11.1-46.3) and the DCR of 66.7% (18/27; 95% CI: 46.0-83.5). The median progression-free-survival (PFS) was 5.32 months (95% CI: 4.31-6.33). The median overall survival (OS) was not reached [62] [60] .

In phase I trial in patients with recurrent high grade glioma, catequentinib was well effective and tolerated (n=12). The median PFS was not reached. Out of 12, 11 patients were evaluated and the study showed that 2 achieved complete response (CR), 3 achieved partial response (PR) and the objective response rate (ORR) was 45.4% (5/11). 6 patients had stale disease (SD) and the disease control rate (DCR) was 100% (11/11). The clinical benefit rate (CBR), defined as the proportion of patients who achieved durable disease control (CR/PR/SD) more than 6 months, was 72.7% (8/11) [31] [30] .

Phase II/III

Treatment with catequentinib in non-small lung cancer patients, demonstrated a longer progression free survival (PFS) [HR=0.439, 95% CI (0.211-0.912), P=0.023] in patients with min/baseline<1. The median PFS for the patients with activated circulating endothelial cells (aCECs) min/baseline <1 and ≥1 were 193 days and 124 days, respectively. A decrease of aCECs counts from baseline during an initial period of catequentinib therapy shows longer PFS and good response in NSCLC patients. The trial enrolled 49 patients, including 35 and 14 having aCECs min/baseline<1 and ≥1, respectively [6] [7] .

Results from the phase II/III ALTER01032 trial in patients with differenciated thyroid cancer showed that the trial met its endpoint of progression free survival (PFS). The median PFS in catequentinib arm was 40.54 months (95% CI 28.29, NE) and 8.38 months (95% CI 5.59, 13.80) in placebo arm (p < 0.0001). The HR was 0.21 (95% CI 0.12, 0.37). A trend of overall survival benefit could be observed (Not reached vs. 52.83 months; HR = 0.57 [95% CI 0.29, 1.12]; p = 0.0976). The prolongation in OS became significant (HR = 0.36 [95%CI 0.18, 0.73], P = 0.0033) when a potential bias from crossover (24 pts received open-label anlotinib) was adjusted with a two-stage estimation method. In the catequentinib arm ORR was 59.21% versus no response in placebo arm (p < 0.0001). The duration of complete response (DCR) was 97.37% versus 78.38% in the catequentinib and placebo arm, respectively (p = 0.0019). The trial enrolled 113 patients [39] [38] .

Subanalysis of the phase IIb/III trial of catequentinib in patients (n = 91) with medullary thyroid carcinoma showed that treatment with catequentinib exhibited greater PFS benefits for patients with better functional status (ECOG PS = 0), younger age or lower tumour burden. For patients in placebo arm, PFS was similar regardless of functional status (ECOG PS) or tumour size while older patients had higher progression risk. Treatment with catequentinib exhibited greater PFS benefits for patients with better functional status (ECOG PS = 0), younger age or lower tumour burden. In placebo arm, mPFS did not differ significantly between patients with ECOG PS 0 and 1 (11.3 versus 11.1 months; HR = 0.895 [95% CI 0.347, 2.312], P = 0.821) or between patients with tumour lesion diameter < 67mm and ≥ 67mm (7.0 versus 11.1 months; HR = 1.168 [95% CI 0.463, 2.945], P = 0.737). Patients in catequentinib arm with ECOG PS 0 obtained more PFS benefits (34.6 versus 14.0 months; HR = 0.331 [95% CI 0.163, 0.671], P = 0.002). catequentinib treated patients with tumour lesion diameters < 67mm achieved a longer mPFS (Not reached versus 14.0 months, HR = 0.567 [95% CI 0.280, 1.147], P = 0.111). Consistent with that has been verified in differentiated thyroid cancer, high age predicted poor prognosis as mPFS were 14.3 months and 6.8 months in patients < 55 and ≥ 55 years old respectively in placebo arm (HR = 0.322 [95% CI 0.116, 0.893], P = 0.007).). catequentinib treatment exhibited PFS improvement to patients in both age groups but higher PFS prolongation was observed in patients < 55 years old (22.4 versus 14.0 months; HR = 0.720 [95% CI 0.321, 1.614], P = 0.381) [43] . Interim results showed that the trial met its primary endpoint of progression free survival (PFS) with a longer median PFS of 20.67 months (95% CI: 14.03-34.63) in catequentinib arm compared with 11.07 (95%CI : 5.82-14.32) months in placebo arm (HR - 0.53, p = 0.0289). A 48.39% improvement in objective response rate (ORR) was reported in patients treated with catequentinib versus 3.45% in the placebo patients (p < 0.0001) [40] [41] .

Updated data from the phase IIb ALTER0203 trial in patients of soft tissue sarcoma showed longer median progression free survival (PFS) in patients of age > 40 year (n=79) than ≤40 y (7.43 vs 5.43 months, P=0.40). In patients receiving catequentinib (n=158), median PFS was longer in female (n=76) than male (9.80 vs 4.43 months, P = 0.002). All enrolled patients had a Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1. Among 158 patients, 107 patients (67.7%) were with poor PS (ECOG PS = 1). The median PFS was longer in PS of 1 (8.43 vs 4.73, P = 0.53) than PS of 0. Earlier, data from the phase IIb trial (n = 56) showed that, in the first line group, the median PFS was 3 months for placebo versus 15.4 months for catequentinib (p=0.0073). In the second line group, the median PFS was 1.5 months for placebo versus NR for catequentinib (p<0.00010. The ORR was 0% for placebo versus 22.22% for catequentinib (P=0.2652), in the first line group and in the second line, the ORR was 0% for placebo versus 25% for catequentinib (P=0.2808). The DCR was 40% for placebo versus 83.33% for catequentinib (P= 0.0346) in first line, when compared with second, the DCR was 37.5% for placebo and 90% for catequentinib (p=0.0095). The randomised 2:1, double-blind and placebo-controlled phase IIb/III trial is designed to assess the safety and efficacy of catequentinib in 233 patients with soft tissue sarcoma [29] [26] [27] [28] .

In the phase II, ALTER0802 study, in cohort 1, progression-free survival rate at 12 weeks (PFR12w) was 80.8% (95%CI, 67.0-97.4); median overall survival (mOS) was 10.8 months (95%CI, 8.0-NE [not estimated]); median TTP (mTTP) was 5.5 months (95%CI, 4.7-NE); disease control rate was 84.6% (95%CI, 65.1-95.6). In cohort 2, PFR12w was 58.8% (95%CI, 39.5-87.6); mOS was not reached; mTTP was 4.01 mo (95%CI, 1.94-11.4); DCR was 76.5% (95%CI, 50.1-93.2) [71] [72] .

Results from a phase I/II clinical trial of anlotinib in combination with TQB 2450 in patients with EGFR+ advanced non-small scale lung cancer demonstrated promising anti-tumor efficacy. Data from the analyzed patients (n=18) showed, 50% patients harbored EGFR exon19 deletion, 44% patients had exon21 L858R mutation. While 39% patients had T790M mutation who progressed after osimertinib treatment. Thirteen patients in the phase II part were administered with dose of 12 mg for anolitinib and 1200mg for TQB 2450. Of the evaluable patients (n = 18), ORR was 11.1%, DCR was 77.8%, median PFS was 8.0 months (95% CI 4.9 to 11.1) [16] [15] .

Updated results from the phase I trial, in patients with solid tumours showed that an overall response rate (ORR) and a and disease control rate (DCR) of 32.8% and 81.8%, respectively. Partial response were reported in four small cell lung cancer (SCLC) patients and one SCLC patient had stable disease. Earlier data showed that TQB 2450 alone and in combination with 12mg anlotinib in four patients with solid tumours demonstrated unconfirmed partial response (2 SCLC and 2 NSCLC). One SCLC patient with 10mg anlotinib plus TQ B2450 had confirmed partial responses [88] [87] [81] .

Result from a phase I trial of anlotinib combined with pemetrexed and carboplatin in non-small cell lung cancer demonstrated significantly improved PFS and ORR compared to standard chemotherapy. At data cut-off, 40 patients were enrolled and 31 of them have received at least one tumor assessment. Reported median age was 62; 66.7% male, 11.1% brain metastasis. Patients were followed up for a median of 8.26 months. Reported median PFS was 10.5 months (95% CI: NE, NE); ORR was 67.7% (0 CR, 21 PR), DCR was 96.8% (0 CR, 21 PR, 9 SD) and median OS was NE [20] [19] .

In a phase II trial in oesophageal squamous cell carcinoma patients (n=34) of paclitaxel and cisplatin combined with anlotinib, there were one confirmed CR (2.9%), 26 confirmed PR (76.5%), 2 unconfirmed PR (5.9%) and 5 SD (14.7%). Consequently, ORR was 79.4% (95%CI: 62.1̃91.3) and DCR was 100.0% (95%CI: 89.7̃100.0). Eleven patients discontinued treatment due to PD, the preliminary prognostic result indicated that the median PFS of the 34 patients was 9.76 months (95%CI: 8.44-13.08). And the median OS was not yet available [37] [36] .

In a phase I trial in breast cancer patients treated with TQB 2450 plus anlotinib (n = 34), the objective response rate (ORR) was 26.47% (9/34) and disease control rate (DCR) was 82.35% (28/34). The median progression-free survival (PFS) was 8.57 months [86] [21] .

Catequentinib demonstrated efficacy in phase II trial in patients with ovarian cancer in patients with recurrent platinum-resistant or refractory ovarian carcinoma. Objective response rate (ORR) was achieved in 29.2% of patients with disease control rate of 75% (95% CI: 53.3-90.2). The median progression free survival was 6.34 months (95% CI: 3.14-9.54). Complete response, partial response, stable disease and progression disease was 4.2%, 25%, 45.8% and 25% respectively. The median overall survival was not reached [61] . In the phase II trial, treatment with catequentinib in combination with peremetex demonstrated overall response rate (ORR) 36.4% (partial response (PR) in eight patients; 95% CI: 17.2-59.3) in patients with ovarian cancer. The disease control rate (DCR) was 100.0% (PR in eight patients and stable disease (SD) in 14 patients; 95% CI: 73.5-100). The median time of the first response was 1.6 months (range, 1.3-4.4). The median progression free survival (PFS) was 9.3 months (95% CI: NE-NE). Furthermore, the ORR of patients with and without prior antiangiogenic therapy was 16.7% (95%CI: 2.1-48.4) and 60.0% (95%CI: 26.2-87.8) respectively (P = 0.074) [59] [60] .

In a phase II trial, penpulimab [see Adis Insight drug profile 800050249] plus catequentinib showed favorable antitumour activity in patients with advanced head, neck and chest cancer. At data cut-off (28 April 2021), the confirmed objective response rate (ORR) was 28% (0 complete response and 7 partial response) and disease control rate (DCR) was 84% (15/20). Stable disease was reported in 14 patients lasting 4 weeks. Progression-free survival (PFS) at 6 months was 64.3%. In the treatment period, progressive disease (PD) was reported in nine patients. For seven patients who reported partial response, only two patients developed the PD and the longest duration of response was 7.2 months. The data were reported from 30 patients who were enrolled and treated between 10 June 2020 to 16 April 2021 [52] [51] [50] .

Results of the open-label phase II trial of penpulimab, in combination with anlotinib hydrochloride demonstrated anti-tumour activity in 25 evaluable patients with unresectable hepatocellular carcinoma. Out of 25 evaluable patients (with the opportunity to be followed-up for ≥2 scans, 12 weeks), confirmed ORR was 24% (6/25) and DCR was 84% (21/25). Five responders remained in response with DoR ranging 1.4+ to 6.9+ months. Median TTP was not reached and six months-TTP rate was 63% (95% CI: 38%, 81%) [58] [57] .

Phase I/II

Results from a phase I/II trial in ovarian cancer at data cutoff date 15 Jan 2021 the median follow-up was 5.1 months (range, 0.1–10.8). Thirteen patients from 25 evaluable patients achieved partial response, yielding the ORR of 52.0% (95% CI, 30.4%–71.6%). The median PFS was 6.7 months (95% CI, 4.5 months to not reached). The median duration of response and the median OS were not reached [76] [77]

In a phase Ib/II trial, cadonilimab (AK 104) in combination with catequentinib (anlotinib) demonstrated favourable antitumour activity in treatment-naïve patients with PD-L1 tumour proportion score (TPS) = 1% non-small cell lung cancer (NSCLC). In 8 evaluable patients, the objective response rate (ORR) was 62.5% (5/8) and disease control rate (DCR) was 100% (8/8). Among them, the ORR was 80% (4/5) in non-squamous NSCLC. The results were obtained from 18 treatment-naïve NSCLC patients, squamous/non-squamous with PD-L1 TPS ≥1% ho received combination therapy (2 received 10 mg/kg AK 104, 16 received 15 mg/kg AK 104; and all received 12 mg anlotinib) in part 1 of the trial [13] [14] .

Future Events

Expected Date Event Type Description Updated
01 Mar 2022 Trial Update The First Affiliated Hospital of Zhengzhou University plans a phase II trial in Cervical cancer (Combination therapy, Late-stage disease, Metastatic disease, Recurrent, Second-line therapy or greater) (PO) in March 2022 (NCT05137171) (700345294) 02 Dec 2021
18 Nov 2021 Trial Update Chia Tai Tianqing Pharmaceutical Group plans a phase III trial for Soft tissue sarcoma (Combination therapy, Late-stage disease, First-line therapy) in China (NCT05121350) 24 Nov 2021
01 Nov 2021 Trial Update The First Affiliated Hospital of Zhengzhou University plans a phase II trial for Squamous cell carcinoma (Late-stage disease, Metastatic disease, Combination therapy, Inoperable/Unresectable) (PO) in November 2021 (NCT05038813) 15 Sep 2021
31 Aug 2021 Trial Update Tianjin Medical University Cancer Institute and Hospital and Chia Tai Tianqing Pharmaceutical plan a phase II in Non-small cell lung cancer (Combination therapy, Late-stage disease, Metastatic disease) in China (PO) in August 2021 (NCT04846634) (700335928) 15 Sep 2021
01 Jun 2021 Trial Update Chia Tai Tianqing Pharmaceutical Group plans a phase III trial for Colorectal cancer (Combination therapy, Metastatic disease, Inoperable/unresectable, First-line therapy) in China (PO) in June 2021 (NCT04854668) (700336223) 30 Aug 2021
30 Apr 2020 Trial Update Chia Tai Tianqing Pharmaceutical Group plans a phase III trial for Non-small-cell lung cancer (Combination therapy, Late-stage disease, Inoperable/Unresectable, Second-line therapy or greater) in China in April 2020 (NCT04325763) (700320320) 17 Jul 2020
31 Mar 2020 Trial Update Chia Tai Tianqing Pharmaceutical Group plans a phase II trial for Solid tumours (Late-stage disease, Combination therapy) in China (PO) in March 2020 (NCT04291248) (700319405) 15 Sep 2021
31 Jan 2020 Trial Update Chia Tai Tianqing Pharmaceutical Group plans a phase I/II trial for TQB 2450 in combination with anlotinib for Epithelial ovarian, Fallopian tube or Primary peritoneal cancer (Combination therapy, In adults, In the elderly, Second-line therapy or greater) (IV) in China in January 2020 (NCT04236362) 09 Jul 2020
01 Jan 2020 Trial Update Chia Tai Tianqing Pharmaceutical Group plans a phase II trial for Head, neck and chest cancer (Late-stage disease, Metastatic disease, Combination therapy) in China in January 2020 (NCT04203719) (700316191) 09 Jul 2020
01 Jan 2020 Trial Update Chia Tai Tianqing Pharmaceutical Group plans a phase II trial for Cholangiocarcinoma (Metastatic disease, Combination therapy, Inoperable/Unresectable, Second-line therapy or greater), Colorectal cancer (Recurrent, Metastatic disease, Combination therapy, Inoperable/Unresectable), Gastric cancer (Recurrent, Metastatic disease, Combination therapy), Urogenital cancer (Metastatic disease, Late-stage disease, Combination therapy, Inoperable/Unresectable), Neuroendocrine tumours (Late-stage disease, Combination therapy) in China in January 2020 (NCT04207463) (700316388) 26 Jun 2020
31 Oct 2019 Trial Update Chia Tai Tianqing Pharmaceutical plans a phase III trial (Combination therapy) for Non-small Cell Lung Cancer in China (NCT04073537) (700310950) 15 Sep 2021
31 Oct 2019 Trial Update Chia Tai Tianqing Pharmaceutical plans a phase III trial (Combination therapy) for Small cell lung cancer in China (NCT04073550) (700310954) 15 Sep 2021
25 Jun 2019 Trial Update Chia Tai Tianqing Pharmaceutical Group plans a phase I/II trial for Melanoma (Late-stage disease, Combination therapy, In adults, In the elderly, Second-line therapy or greater) in China (NCT03991975) (700308620) 15 Nov 2019
10 May 2019 Trial Update Chia Tai Tianqing Pharmaceutical Group plans a phase I trial in Solid tumours (Combination therapy, Late stage disease, Metastatic disease) in May 2019 (PO) (NCT03897283) (700306031) 30 Nov 2020
17 Aug 2018 Trial Update Jiangsu Chia-tai Tianqing Pharmaceutical plans a phase III trial for Nasopharyngeal cancer (Recurrent; Late-stage disease, Combination therapy, First-line therapy, Metastatic disease) in August 2018 (PO) (700298206) (NCT03601975) 26 Sep 2018

Development History

Event Date Update Type Comment
30 Nov 2021 Trial Update The First Affiliated Hospital of Zhengzhou University plans a phase II trial in Cervical cancer (Combination therapy, Late-stage disease, Metastatic disease, Recurrent, Second-line therapy or greater) (PO) in March 2022 (NCT05137171) Updated 02 Dec 2021
24 Nov 2021 Biomarker Update Biomarkers information updated Updated 26 Nov 2021
18 Nov 2021 Trial Update Chia Tai Tianqing Pharmaceutical Group plans a phase III trial for Soft tissue sarcoma (Combination therapy, Late-stage disease, First-line therapy) in China (NCT05121350) Updated 24 Nov 2021
06 Oct 2021 Trial Update Chia Tai Tianqing Pharmaceutical initiates enrolment in a phase II trial for Colorectal cancer (Combination therapy, First-line therapy, Unresectable, Metastatic disease, Late-stage diseases) in China (NCT05068206) Updated 06 Oct 2021
16 Sep 2021 Scientific Update Efficacy and safety data from a phase Ib/II trial in Non-small cell lung cancer presented at the 46th European Society for Medical Oncology Congress (ESMO-2021) [13] Updated 25 Nov 2021
16 Sep 2021 Scientific Update Updated efficacy and adverse event data from a phase II trial in Head and neck cancer presented at the 46th European Society for Medical Oncology Congress (ESMO-2021) [52] Updated 25 Nov 2021
16 Sep 2021 Scientific Update Efficacy and adverse events data from a phase II trial in Glioblastoma presented at the 46th European Society for Medical Oncology Congress [31] Updated 24 Nov 2021
16 Sep 2021 Scientific Update Efficacy and adverse events data from a phase II trial in Ovarian cancer presented at the 46th European Society for Medical Oncology Congress (ESMO-2021) [62] Updated 18 Nov 2021
14 Sep 2021 Trial Update Chia Tai Tianqing Pharmaceutical and Hunan Cancer Hospital complete phase II trial for Non-small cell lung cancer (Combination therapy, Late-stage disease, Second-line therapy or greater) in China (PO) before September 2021 (NCT03624309) Updated 12 Oct 2021
09 Sep 2021 Trial Update The First Affiliated Hospital of Zhengzhou University plans a phase II trial for Squamous cell carcinoma (Late-stage disease, Metastatic disease, Combination therapy, Inoperable/Unresectable) (PO) in November 2021 (NCT05038813) Updated 15 Sep 2021
05 Sep 2021 Phase Change - II Phase-II clinical trials in Glioblastoma (Adjuvant therapy, Newly diagnosed, First-line therapy) in China (PO) (NCT05033587) Updated 09 Sep 2021
30 Aug 2021 Active Status Review CTP 336223: updated, KDM, dev T for trial initiation, completed relevant FE Updated 30 Aug 2021
04 Jun 2021 Trial Update Tianquan Pharmaceutical completes a phase-II study in Small cell lung cancer (First-line therapy, Combination therapy, Late-stage disease) in China (PO) (ChiCTR2000035043) [69] Updated 05 Aug 2021
04 Jun 2021 Scientific Update Efficacy and adverse event data from a phase II trial in Head and neck cancer presented at the 57th Annual Meeting of the American Society of Clinical Oncology (ASCO-2021) [51] Updated 31 Jul 2021
04 Jun 2021 Scientific Update Efficacy and adverse events data from a phase III trial in Synovial sarcoma presented at the 57th Annual Meeting of the American Society of Clinical Oncology (ASCO-2021) [25] Updated 28 Jul 2021
04 Jun 2021 Trial Update Advenchen Laboratories completes enrolment in its phase III trial in Synovial sarcoma (Late-stage disease, Metastatic disease, Recurrent, Inoperable/Unresectable) in Italy and USA (PO) (NCT03016819) [25] Updated 28 Jul 2021
04 Jun 2021 Scientific Update Efficacy and adverse events data from a phase II trial in Oesophageal squamous cell carcinoma presented at 57th Annual Meeting of the American Society of Clinical Oncology (ASCO-2021) [37] Updated 26 Jul 2021
04 Jun 2021 Scientific Update Efficacy and safety data from a phase I/II trial in Ovarian cancer presented at 57th Annual Meeting of the American Society of Clinical Oncology (ASCO-2021) [77] Updated 26 Jul 2021
04 Jun 2021 Scientific Update Efficacy and safety data from a phase I/II trial in Ovarian cancer presented at 57th Annual Meeting of the American Society of Clinical Oncology (ASCO-2021) [77] Updated 24 Jul 2021
04 Jun 2021 Scientific Update Efficacy and adverse events data from a phase II trial in Ovarian cancer presented at the 57th Annual Meeting of the American Society of Clinical Oncology (ASCO-2021) [59] Updated 23 Jul 2021
04 Jun 2021 Scientific Update Efficacy and safety data from a phase I trial in Breast cancer presented at 57th Annual Meeting of the American Society of Clinical Oncology (ASCO-2021) [86] Updated 22 Jul 2021
04 Jun 2021 Scientific Update Initial efficacy and adverse events data from a phase II trial in Non-small cell lung cancer presented at the 57th Annual Meeting of the American Society of Clinical Oncology (ASCO-2021) [16] Updated 10 Jul 2021
04 Jun 2021 Scientific Update Initial efficacy and adverse events data from a phase I trial in Non-small cell lung cancer presented at the 57th Annual Meeting of the American Society of Clinical Oncology (ASCO-2021) [20] Updated 09 Jul 2021
27 May 2021 Phase Change - III Phase-III clinical trials in Colorectal cancer (First-line therapy, Combination therapy, Inoperable/Unresectable, Metastatic disease) in China (PO) (NCT04854668) Updated 30 Aug 2021
22 Apr 2021 Trial Update Chia Tai Tianqing Pharmaceutical Group plans a phase III trial for Colorectal cancer (Combination therapy, Metastatic disease, Inoperable/unresectable, First-line therapy) in China (PO) in June 2021 (NCT04854668) Updated 30 Aug 2021
19 Apr 2021 Trial Update Tianjin Medical University Cancer Institute and Hospital and Chia Tai Tianqing Pharmaceutical plan a phase II in Non-small cell lung cancer (Combination therapy, Late-stage disease, Metastatic disease) in China (PO) in August 2021 (NCT04846634) Updated 15 Sep 2021
15 Apr 2021 Trial Update Akeso initiates enrollment in a phase Ib/II trial for Non-small cell lung cancer (Combination therapy, First line therapy, Late stage disease, Metastatic disease, Second line therapy or greater disease) in China, before April 2021 [13] (NCT04646330) Updated 25 Nov 2021
13 Apr 2021 Phase Change - II Phase-II clinical trials in Glioblastoma (Late-stage disease) in China (PO) (NCT04822805) Updated 24 Nov 2021
02 Dec 2020 Trial Update Chia Tai Tianqing Pharmaceutical Group plans a phase 0 trial for catequentinib in combination with irinotecan for Breast cancer (Late-stage disease, Combination therapy, Second-line therapy or greater) in China (IV) in September 2020 (ChiCTR2000037448) Updated 02 Dec 2020
01 Dec 2020 Trial Update Akeso plans a phase Ib/II trial for Non-small cell lung cancer (Combination therapy, First line therapy, Late stage disease, Metastatic disease, Second line therapy or greater disease) in China (NCT04646330), Updated 01 Dec 2020
04 Nov 2020 Trial Update Chia Tai Tianqing Pharmaceutical Group initiates a phase II trial for Non-small cell lung cancer (Combination therapy, Late-stage disease, Metastatic disease, Second-line therapy or greater) in China (NCT04619563) Updated 24 Nov 2020
19 Oct 2020 Trial Update Shandong Cancer Hospital plans a phase II trial for Cervical cancer (Combination therapy, Metastatic disease, Late-stage disease, Second-line therapy or greater) in China (ChiCTR2000037497) Updated 02 Dec 2020
19 Sep 2020 Scientific Update Efficacy and adverse events data from the phase II/III ALTER01032 trial in Thyroid cancer presented at the 45th European Society for Medical Oncology Congress (ESMO-2020) [39] Updated 13 Oct 2020
19 Sep 2020 Scientific Update Efficacy and adverse event data from the phase II ALTER1202 trial in Small cell lung cancer presented at the 45th European Society for Medical Oncology Congress (ESMO-2020) [68] Updated 08 Oct 2020
01 Jul 2020 Trial Update Phase-I/II clinical trials in Ovarian cancer (Combination therapy, In adults, In the elderly, Second-line therapy or greater) in China (IV) (NCT04236362) Updated 09 Jul 2020
03 Jun 2020 Phase Change - II Phase-II clinical trials in Cholangiocarcinoma (Metastatic disease, Combination therapy, Inoperable/Unresectable, Second-line therapy or greater) in China (PO) (NCT04207463) Updated 26 Jun 2020
03 Jun 2020 Phase Change - II Phase-II clinical trials in Colorectal cancer (Metastatic disease, Recurrent, Combination therapy, Inoperable/Unresectable) in China (PO) (NCT04207463) Updated 26 Jun 2020
03 Jun 2020 Phase Change - II Phase-II clinical trials in Gastric cancer (Recurrent, Metastatic disease, Combination therapy) in China (PO)(NCT04207463) Updated 26 Jun 2020
03 Jun 2020 Phase Change - II Phase-II clinical trials in Neuroendocrine tumours (Late-stage disease, Combination therapy) in China (PO) (NCT04207463) Updated 26 Jun 2020
03 Jun 2020 Phase Change - II Phase-II clinical trials in Urogenital cancer (Metastatic disease, Late-stage disease, Combination therapy, Inoperable/Unresectable) in China (PO) (NCT04207463) Updated 26 Jun 2020
29 May 2020 Scientific Update Interim efficacy and adverse events data from a phase II trial in liver cancer presented at the 56th Annual Meeting of the American Society of Clinical Oncology (ASCO-2020) [58] Updated 10 Aug 2021
29 May 2020 Scientific Update Efficacy data from the phase II/III ALTER0203 trial in Soft tissue sarcoma presented at the 56th Annual Meeting of the American Society of Clinical Oncology (ASCO-2020) [29] Updated 03 Jul 2020
29 May 2020 Scientific Update Interim pharmacodynamics data from a phase IIb/III trial in thyroid cancer presented at the 56th Annual Meeting of the American Society of Clinical Oncology (ASCO-2020) [42] Updated 13 Jun 2020
29 May 2020 Scientific Update Interim efficacy data from a phase IIb/III trial in thyroid cancer presented at the 56th Annual Meeting of the American Society of Clinical Oncology (ASCO-2020) [43] Updated 13 Jun 2020
29 May 2020 Scientific Update Efficacy and adverse events data from a phase II trial in Bone cancer presented at the 56th Annual Meeting of the American Society of Clinical Oncology(ASCO-2020) [64] Updated 10 Jun 2020
13 May 2020 Trial Update Chia Tai Tianqing Pharmaceutical plans a phase III trial for Gastric and Oesophageal cancer (Combination therapy, Late-stage disease, Metastatic disease, First-line therapy) in China (PO) in May 2020 (NCT04385550) Updated 10 Aug 2021
09 May 2020 Phase Change - II Phase-II clinical trials in Head and neck cancer (Combination therapy, Late-stage disease, Metastatic disease, Second-line therapy or greater, Recurrent) in China (PO) (NCT04203719) Updated 09 Jul 2020
16 Apr 2020 Trial Update Chia Tai Tianqing Pharmaceutical plans a phase III trial for Liver cancer (Combination therapy, Second line treatment of greater, Late-stage disease) in China (PO) in May 2020 (NCT04344158) Updated 10 Aug 2021
13 Apr 2020 Trial Update Chia Tai Tianqing Pharmaceutical Group initiates a phase II ALTER-H-004 trial in Liver cancer in China (NCT04213118) Updated 24 Apr 2020
30 Mar 2020 Phase Change - III Phase-III clinical trials in Non-small cell lung cancer (Late-stage disease, Combination therapy, Monotherapy, Inoperable/Unresectable, Second-line therapy or greater) in China (PO) (NCT04325763) Updated 17 Jul 2020
30 Mar 2020 Trial Update Chia Tai Tianqing Pharmaceutical Group plans a phase III trial for Non-small-cell lung cancer (Combination therapy, Late-stage disease, Inoperable/Unresectable, Second-line therapy or greater) in China in April 2020 (NCT04325763) Updated 17 Jul 2020
12 Mar 2020 Phase Change - II Phase-II clinical trials in Fallopian tube cancer (Combination therapy, Recurrent, Second-line therapy or greater) in China (PO) (ChiCTR2000030726) Updated 23 Jun 2020
12 Mar 2020 Phase Change - II Phase-II clinical trials in Ovarian cancer (Combination therapy, Recurrent, Second-line therapy or greater) in China (PO) (ChiCTR2000030726) Updated 23 Jun 2020
12 Mar 2020 Phase Change - II Phase-II clinical trials in Peritoneal cancer (Combination therapy, Second-line therapy or greater, Recurrent) in China (PO) (ChiCTR2000030726) Updated 23 Jun 2020
05 Mar 2020 Trial Update Chia Tai Tianqing Pharmaceutical Group plans a phase II trial for Solid tumours (Late-stage disease, Combination therapy) in China (PO) in March 2020 (NCT04291248) Updated 15 Sep 2021
05 Mar 2020 Trial Update Chia Tai Tianqing Pharmaceutical Group plans a phase II trial for Solid tumours (Late-stage disease) in China (IV) in March 2020 (NCT04291248) Updated 10 Aug 2021
22 Jan 2020 Trial Update Chia Tai Tianqing Pharmaceutical Group plans a phase I/II trial for TQB 2450 in combination with anlotinib for Epithelial ovarian, Fallopian tube or Primary peritoneal cancer (Combination therapy, In adults, In the elderly, Second-line therapy or greater) (IV) in China in January 2020 (NCT04236362) Updated 09 Jul 2020
20 Dec 2019 Trial Update Chia Tai Tianqing Pharmaceutical Group plans a phase II trial for Cholangiocarcinoma (Metastatic disease, Combination therapy, Inoperable/Unresectable, Second-line therapy or greater), Colorectal cancer (Recurrent, Metastatic disease, Combination therapy, Inoperable/Unresectable), Gastric cancer (Recurrent, Metastatic disease, Combination therapy), Urogenital cancer (Metastatic disease, Late-stage disease, Combination therapy, Inoperable/Unresectable), Neuroendocrine tumours (Late-stage disease, Combination therapy) in China in January 2020 (NCT04207463) Updated 26 Jun 2020
18 Dec 2019 Trial Update Chia Tai Tianqing Pharmaceutical Group plans a phase II trial for Head, neck and chest cancer (Late-stage disease, Metastatic disease, Combination therapy) in China in January 2020 (NCT04203719) Updated 09 Jul 2020
01 Dec 2019 Trial Update Chia Tai Tianqing Pharmaceutical Group completes the phase II/III ALTER01032 trial for Thyroid cancer in China (PO) (NCT02586337) Updated 21 Oct 2020
28 Oct 2019 Trial Update Chia Tai Tianqing Pharmaceutical and Zhengda Tianqing Pharmaceutical initiates enrolment in a phase I/II trial for Non-small cell lung cancer (Combination therapy, Second-line therapy or greater, late-stage disease) in China (ChiCTR1900026273) Updated 10 Jul 2021
07 Oct 2019 Phase Change - II Phase-II clinical trials in Squamous cell cancer (Combination therapy, First-line therapy, Late-stage disease) in China (PO) (NCT04063683) Updated 23 Apr 2020
27 Sep 2019 Scientific Update Efficacy data from the phase IIb ALTER0203 trial in Soft tissue sarcoma presented at the 44th European Society for Medical Oncology Congress (ESMO-2019) [26] Updated 22 Feb 2020
27 Sep 2019 Scientific Update Safety and efficacy data from the phase II ALTER0802 study in Liver cancer presented at the 44th European Society for Medical Oncology Congress (ESMO-2019) [71] Updated 22 Feb 2020
27 Sep 2019 Scientific Update Efficacy data from the phase II ALTER1202 trial in Small cell lung cancer presented at the 44th European Society for Medical Oncology Congress (ESMO-2019) [66] Updated 21 Feb 2020
29 Aug 2019 Trial Update Chia Tai Tianqing Pharmaceutical plans a phase III trial (Combination therapy) for Non-small Cell Lung Cancer in China (NCT04073537) Updated 15 Sep 2021
29 Aug 2019 Trial Update Chia Tai Tianqing Pharmaceutical plans a phase III trial (Combination therapy) for Small cell lung cancer in China (NCT04073550) Updated 15 Sep 2021
08 Aug 2019 Phase Change - III Phase-III clinical trials in Non-small cell lung cancer (Combination therapy, Late-stage disease, Metastatic disease, Second-line therapy or greater) in China (PO, Capsule) (NCT04439890) Updated 25 Jun 2020
30 Jun 2019 Licensing Status Chia Tia Tianqing Pharmaceutical Group and Akeso Biopharma form a Joint venture for development and commercialisation of penpulimab [1] Updated 10 Aug 2021
21 Jun 2019 Trial Update Chia Tai Tianqing Pharmaceutical Group plans a phase I/II trial for Melanoma (Late-stage disease, Combination therapy, In adults, In the elderly, Second-line therapy or greater) in China (NCT03991975) Updated 15 Nov 2019
20 Jun 2019 Phase Change - I Phase-I clinical trials in Solid tumours (Combination therapy, Late-stage disease, Metastatic disease) in China (PO) (NCT03897283) Updated 30 Nov 2020
19 Jun 2019 Trial Update Advenchen Laboratories terminates a phase I/IIa trial in Endometrial cancer, Ovarian cancer and Cervical cancer (Metastatic disease, Recurrent, Second-line therapy or greater) in USA (NCT02558348) Updated 26 Jun 2019
11 Jun 2019 Phase Change - I/II Phase-I/II clinical trials in Acral lentiginous melanoma (Second-line therapy or greater, Combination therapy, Late-stage disease) in China (PO) (NCT03991975) Updated 15 Nov 2019
11 Jun 2019 Trial Update Chia Tai Tianqing Pharmaceutical initiates enrolment in a phase I trial for Non-small cell lung cancer (Combination therapy, Late-stage disease, Second-line therapy or greater) in China (IV) (NCT03910127) Updated 15 Nov 2019
03 Jun 2019 Phase Change - I Phase-I clinical trials in Non-small cell lung cancer (Combination therapy, Late-stage disease) in China (PO) (NCT03983928) Updated 21 Aug 2019
01 Jun 2019 Scientific Update Efficacy and adverse events data from a phase II/III trial in Thyroid cancer presented at the 55th Annual Meeting of the American Society of Clinical Oncology (ASCO-2019) [40] Updated 03 Jun 2019
31 May 2019 Scientific Update Efficacy and safety data from the phase IIb ALTER0203 trial in Soft tissue sarcoma presented at the 55th Annual Meeting of American Society of Clinical Oncology (ASCO-2019) [27] Updated 14 Jun 2019
29 May 2019 Trial Update Chia Tai Tianqing Pharmaceutical Group completes enrolment in its phase II/III ALTER01032 trial for Thyroid cancer in China (PO) (NCT02586337) Updated 13 Oct 2020
09 May 2019 Phase Change - I Phase-I clinical trials in Breast cancer (Combination therapy, Second-line therapy or greater, Metastatic disease) in China (PO) (NCT03855358) Updated 22 Jul 2021
06 May 2019 Trial Update Chia Tai Tianqing Pharmaceutical completes the ALTER1202 phase II trial in Small cell lung cancer in China (NCT03059797) Updated 21 May 2019
16 Apr 2019 Trial Update Chia Tai Tianqing Pharmaceutical Group plans a phase I trial for Non-small cell lung cancer (Late-stage disease, Combination therapy, Second-line therapy or greater) in China (NCT03910127) Updated 16 Apr 2019
12 Apr 2019 Trial Update Chia Tai Tianqing Pharmaceutical initiates enrolment in a phase II trial for Non small cell lung cancer (Late-stage disease, Metastatic disease, Inoperable/unresectable) in China (NCT03743129) Updated 12 Sep 2019
01 Apr 2019 Trial Update Chia Tai Tianqing Pharmaceutical Group plans a phase I trial in Solid tumours (Combination therapy, Late stage disease, Metastatic disease) in May 2019 (PO) (NCT03897283) Updated 30 Nov 2020
22 Mar 2019 Phase Change - I Phase-I clinical trials in Non-small cell lung cancer (Combination therapy, First-line therapy, Late-stage disease, Locally recurrent) in China (PO) (NCT03790228) Updated 09 Jul 2021
01 Mar 2019 Phase Change - II Phase-II clinical trials in Fallopian tube cancer (Late-stage disease, Second-line therapy or greater) in China (PO) (ChiCTR2000029654) Updated 23 Jun 2020
01 Mar 2019 Phase Change - II Phase-II clinical trials in Ovarian cancer (Second-line therapy or greater) in China (PO) (ChiCTR2000029654) Updated 23 Jun 2020
01 Mar 2019 Phase Change - II Phase-II clinical trials in Peritoneal cancer (Late-stage disease, Second-line therapy or greater) in China (PO) (ChiCTR2000029654) Updated 23 Jun 2020
01 Mar 2019 Trial Update Jiangsu Chia-Tai Tianqing Pharmaceutical completes the phase-II/III ALTER0703 trial in Colorectal cancer (Late-stage disease, Metastatic disease, Second-line therapy or greater) in China (PO) (NCT02332499) Updated 28 May 2019
15 Jan 2019 Phase Change - II Phase-II study in Small cell lung cancer (First-line therapy, Combination therapy, Late-stage disease) in China (PO) (ChiCTR2000035043) Updated 05 Aug 2021
06 Dec 2018 Phase Change - I/II Phase-I/II clinical trials in Non-small cell lung cancer (Combination therapy, Late-stage disease, Metastatic disease, Second-line therapy or greater) in China (PO) (NCT03706287) Updated 15 Apr 2020
22 Nov 2018 Phase Change - II Phase-II clinical trials in Liver cancer (squamous) (Combination therapy, First-line therapy, Inoperable/Unresectable) in China (PO) (NCT04172571) Updated 10 Aug 2021
23 Oct 2018 Phase Change - II Phase-II clinical trials in Gastrointestinal stromal tumours (Metastatic disease, Recurrent, Second-line therapy or greater, Late-stage disease) in China (PO) (NCT04106024) Updated 04 Oct 2019
16 Oct 2018 Trial Update Chia Tai Tianqing Pharmaceutical Group plans a phase II trial for Non-small Cell Lung Cancer (Second-lie therapy or greater, Late-stage disease) in China , (NCT03703596) Updated 17 Oct 2018
15 Oct 2018 Trial Update Chia Tai Tianqing Pharmaceutical and Hunan Cancer Hospital initiate enrolment in a phase II trial for Non-small cell lung cancer (Combination therapy, Late-stage disease, Second-line therapy or greater) in China (PO) (NCT03624309) Updated 10 Jul 2021
30 Sep 2018 Trial Update Jiangsu Chia-Tai Tianqing Pharmaceutical completes the phase-II/III ALTER01031 trial in Thyroid cancer (Late-stage disease) in China (PO) (NCT02586350) Updated 29 May 2019
02 Sep 2018 Phase Change - III Phase-III clinical trials in Nasopharyngeal cancer (Recurrent, Late-stage disease, Metastatic disease, Combination therapy, First-line therapy) in China (PO) (NCT03601975) Updated 26 Sep 2018
15 Aug 2018 Trial Update Chia Tai Tianqing Pharmaceutical completes a phase I trial in Solid tumours (Late-stage disease, Second-line therapy or greater) in China (PO) (NCT02825563) Updated 31 May 2019
26 Jul 2018 Trial Update Jiangsu Chia-tai Tianqing Pharmaceutical plans a phase III trial for Nasopharyngeal cancer (Recurrent; Late-stage disease, Combination therapy, First-line therapy, Metastatic disease) in August 2018 (PO) (NCT03601975) Updated 26 Sep 2018
23 Jul 2018 Trial Update Chia Tai Tianqing Pharmaceutical Group completes the phase II ALTER1102 trial in Squamous cell cancer (Second-line therapy or greater, Metastatic disease, Late-stage disease) in China (PO) (NCT02649361) Updated 10 Jun 2019
12 Jun 2018 Trial Update Jiangsu Chia-tai Tianqing Pharmaceutical completes a phase II trial in Soft tissue sarcoma (Second-line therapy or greater, Late-stage disease) in China (PO) Updated 17 Jul 2018
15 May 2018 Trial Update Jiangsu Chia-tai Tianqing Pharmaceutical plans a phase II trial for Bone cancers (Late-stage disease) in May 2018 , (NCT03527888) Updated 23 May 2018
11 May 2018 Phase Change - Marketed Launched for Non-small cell lung cancer (Late-stage disease, Metastatic disease, Second-line therapy or greater) in China (PO) - First global launch [2] Updated 18 May 2018
10 May 2018 Phase Change - Registered Registered for Non-small cell lung cancer (Late-stage disease, Metastatic disease, Second-line therapy or greater) in China (PO) - First global approval [2] Updated 18 May 2018
31 Jan 2018 Phase Change - II Phase-II clinical trials in Bone cancer (Recurrent, Metastatic disease, In adolescents, In adults, In the elderly, Second-line therapy or greater) in China (PO) (NCT03527888) Updated 10 Jun 2020
30 Jan 2018 Phase Change - II Phase-II clinical trials in Neuroendocrine tumours (In adults, In the elderly, Late-stage disease, Inoperable/Unresectable, Metastatic disease, Second-line therapy or greater) in China (PO) (NCT03457844) Updated 15 Mar 2018
22 Jan 2018 Phase Change - II Phase-II clinical trials in Ewing's Sarcoma (Late-stage disease, Second-line therapy or greater) in China (PO) (NCT03416517) Updated 05 Feb 2018
17 Aug 2017 Other Chemical structure information added Updated 17 Aug 2017
15 Aug 2017 Phase Change - III Phase-III clinical trials in Alveolar soft part sarcoma (Late-stage disease, Metastatic disease, Inoperable/Unresectable) in Italy and USA (PO) (NCT03016819) Updated 18 May 2018
15 Aug 2017 Phase Change - III Phase-III clinical trials in Leiomyosarcoma (Late-stage disease, Metastatic disease, Inoperable/Unresectable, Recurrent) in Italy and USA (PO) (NCT03016819) Updated 18 May 2018
15 Aug 2017 Phase Change - III Phase-III clinical trials in Synovial sarcoma (Late-stage disease, Metastatic disease, Recurrent, Inoperable/Unresectable) in Italy and USA (PO) (NCT03016819) Updated 18 May 2018
01 Aug 2017 Trial Update Jiangsu Chia-tai Tianqing Pharmaceutical completes a phase I trial for Solid tumours (Late-stage disease) in China (PO) (NCT02622932) Updated 08 May 2019
02 Jun 2017 Scientific Update Updated efficacy and adverse events data from the phase III ALTER-0303 trial in Non-small cell lung cancer presented at the 53rd Annual Meeting of the American Society of Clinical Oncology (ASCO-2017) [5] Updated 31 Jul 2017
02 Jun 2017 Scientific Update Efficacy data from the phase II/III ALTER-0303 trial in Non small cell lung cancer presented at the 53rd Annual Meeting of the American Society of Clinical Oncology (ASCO-2017) [6] Updated 15 Jul 2017
02 Jun 2017 Scientific Update Pharmacokinetics and safety data from a phase I trial in Ovarian and Endometrial cancer presented at the 53rd Annual Meeting of the American Society of Clinical Oncology (ASCO-2017) [79] Updated 15 Jul 2017
01 Mar 2017 Phase Change - II Phase-II clinical trials in Small cell lung cancer (Late-stage disease, Second-line therapy or greater) in China (PO) (NCT03059797) Updated 17 Mar 2017
26 Feb 2017 Trial Update Jiangsu Chia-tai Tianqing Pharmaceutical plans the ALTER1202 phase II trial for Small cell lung cancer (Second-line therapy or greater) in China (NCT03059797) Updated 01 Mar 2017
09 Jan 2017 Trial Update Advenchen Laboratories plans the phase III APROMISS trial for Alveolar soft part sarcoma (Inoperable/Unresectable, Metastatic disease, Late-stage disease), Leiomyosarcoma and Synovial-sarcoma (Recurrent, Inoperable/Unresectable, Metastatic disease, Late-stage disease, Second-line therapy or greater) in USA (PO) (NCT03016819) Updated 13 Jan 2017
06 Jan 2017 Trial Update Jiangsu Chia-tai Tianqing Pharmaceutical completes a phase II/III trial in Non-small cell lung cancer (Late-stage disease, Metastatic disease, Second-line therapy or greater) in China (PO) (NCT02388919) Updated 10 Feb 2017
01 Dec 2016 Trial Update Chia Tai Tianqing Pharmaceutical completes phase-II clinical trials in Thyroid cancer (Late-stage disease) in China (PO) (NCT01874873) Updated 30 May 2019
01 Sep 2016 Phase Change - II Phase-II clinical trials in liver cancer in China (PO) (NCT02809534) Updated 28 Sep 2016
20 Jul 2016 Phase Change - III Phase-III clinical trials in Thyroid cancer, Thyroid cancer (Late-stage disease), Non-small cell lung cancer (Late-stage disease, Second-line therapy or greater), Gastric cancer and Colorectal cancer (Late-stage disease, Metastatic disease, Second-line therapy or greater) in China (PO) (Advenchen Laboratories pipeline, July 2016) Updated 23 Jul 2016
21 Jun 2016 Trial Update Jiangsu Chia-tai Tianqing Pharmaceutical plans the phase II ALTER0802 trial for liver cancer in China (PO) (NCT02809534) Updated 27 Jun 2016
01 Jun 2016 Trial Update Jiangsu Chia-tai Tianqing Pharmaceutical initiates a phase I trial for Solid tumours (Late-stage disease, Second-line therapy or greater) in China (PO) (NCT02825563) Updated 12 Jul 2016
27 Apr 2016 Trial Update Jiangsu Chia-tai Tianqing Pharmaceutical initiates a phase I pharmacokinetics trial for Solid tumours (Late-stage disease) in China (PO) (NCT02752516) Updated 29 Apr 2016
01 Jan 2016 Phase Change - II Phase-II clinical trials in Squamous cell cancer (Second-line therapy or greater, Metastatic disease, Late-stage disease) in China (PO) (NCT02649361) Updated 12 Jan 2016
02 Dec 2015 Trial Update Jiangsu Chia-tai Tianqing Pharmaceutical initiates a phase I pharmacokinetics trial for Solid tumours (Late-stage disease) in China (PO) (NCT02622932) Updated 29 Apr 2016
01 Dec 2015 Phase Change - I/II Phase-I/II clinical trials in Cervical cancer (Adjunctive treatment, Recurrent, Metastatic disease, Second-line therapy or greater) in USA (PO) (NCT02584478) Updated 17 Dec 2015
01 Dec 2015 Phase Change - I/II Phase-I/II clinical trials in Endometrial cancer (Adjunctive treatment, Recurrent, Metastatic disease, Second-line therapy or greater) in USA (PO) (NCT02584478) Updated 17 Dec 2015
01 Dec 2015 Phase Change - I/II Phase-I/II clinical trials in Fallopian tube cancer (Adjunctive treatment, Metastatic disease, Recurrent, Second-line therapy or greater) in USA (PO) (NCT02584478) Updated 17 Dec 2015
01 Dec 2015 Phase Change - I/II Phase-I/II clinical trials in Ovarian cancer (Adjunctive treatment, Metastatic disease, Recurrent, Second-line therapy or greater) in USA (PO) (NCT02584478) Updated 17 Dec 2015
01 Dec 2015 Phase Change - I/II Phase-I/II clinical trials in Peritoneal cancer (Adjunctive treatment, Metastatic disease, Recurrent, Second-line therapy or greater) in USA (PO) (NCT02584478) Updated 17 Dec 2015
01 Dec 2015 Trial Update Jiangsu Chia-tai Tianqing Pharmaceutical plans a phase I pharmacokinetics trial for Cancer (Late-stage disease) in China (NCT02622932) Updated 10 Dec 2015
01 Nov 2015 Phase Change - I/II Phase-I/II clinical trials in Cervical cancer (Metastatic disease, Recurrent, Second-line therapy or greater) in USA (PO) (NCT02558348) Updated 26 Nov 2015
01 Nov 2015 Phase Change - I/II Phase-I/II clinical trials in Endometrial cancer (Metastatic disease, Recurrent, Second-line therapy or greater) in USA (PO) (NCT02558348) Updated 26 Nov 2015
01 Nov 2015 Phase Change - I/II Phase-I/II clinical trials in Ovarian cancer (Metastatic disease, Recurrent, Second-line therapy or greater) in USA (PO) (NCT02558348) Updated 26 Nov 2015
21 Oct 2015 Trial Update Advenchen Laboratories plans a phase Ib/IIa trial for Endometrial cancer, Ovarian cancer, Fallopian tube caner, Peritoneal cancer or Cervical cancer (Metastatic disease, Recurrent, Second-line therapy or greater, Adjunctive treatment) in USA (PO) (NCT02584478) Updated 28 Oct 2015
05 Oct 2015 Licensing Status Advenchen Laboratories and Jiangsu Chia-tai Tianqing Pharmaceutical agree to co-develop anlotinib (now catequentinib) for Cancer (Advenchen Laboratories website, September 2015) Updated 05 Oct 2015
05 Oct 2015 Trial Update Advenchen Laboratories plans a phase Ib/IIa trial for Endometrial cancer (Metastatic disease), Ovarian cancer (Second-line therapy or greater) or Cervical cancer (Second-line therapy or greater) in USA (PO) (NCT02558348) Updated 05 Oct 2015
01 Oct 2015 Trial Update Chia Tai Tianqing Pharmaceutical completes a phase II trial in Non-small cell lung cancer (second-line therapy or greater, late-stage disease) in China (NCT01924195) Updated 02 Nov 2015
01 Oct 2015 Trial Update Jiangsu Chia-tai Tianqing Pharmaceutical completes a phase I trial in Cancer in China (NCT01833923) Updated 02 Nov 2015
01 Aug 2015 Trial Update Chia Tai Tianqing Pharmaceutical Group completes a phase II trial in Cancer (Late-stage disease, Second-line therapy or greater) in China (PO) (NCT04216082) Updated 10 Jan 2020
01 Jul 2015 Phase Change - II/III Phase-II/III clinical trials in Thyroid cancer (Late-stage disease) in China (PO) (NCT02586350) Updated 29 Oct 2015
01 Jul 2015 Phase Change - II/III Phase-II/III clinical trials in Thyroid cancer in China (PO) (NCT02586337) Updated 29 Oct 2015
30 Jun 2015 Phase Change - II/III Phase-II/III clinical trials in Gastric cancer in China (PO) (NCT02461407) Updated 10 Nov 2015
08 Jun 2015 Trial Update Jiangsu Chia-tai Tianqing Pharmaceutical plans the phase II/II ALTER0503 trial for Gastric cancer in China (NCT02461407) Updated 08 Jun 2015
17 May 2015 Trial Update Jiangsu Chia-tai Tianqing initiates enrolment in the phase II/III ALTER0203 trial in Soft tissue sarcoma (Second-line therapy or greater) in China (NCT02449343) Updated 23 May 2015
01 Jan 2015 Regulatory Status Anlotinib (now catequentinib) receives Orphan Drug status for Ovarian cancer in USA (NCT04106024) Updated 04 Oct 2019
01 Jan 2015 Phase Change - II/III Phase-II/III clinical trials in Non-small cell lung cancer (Late-stage disease, Second-line therapy or greater, Metastatic disease) in China (PO) (NCT02388919) Updated 27 Mar 2015
01 Dec 2014 Phase Change - II/III Phase-II/III clinical trials in Colorectal cancer (Late-stage disease, Metastatic disease, Second-line therapy or greater) in China (PO) (NCT02332499) Updated 09 Jan 2015
31 Dec 2013 Trial Update Jiangsu Chia-tai Tianqing Pharmaceutical initiates enrolment in a phase II trials in Renal cell carcinoma (Late-stage disease) in China (PO) (NCT02072031) Updated 06 Mar 2014
31 Dec 2013 Trial Update Jiangsu Chia-tai Tianqing Pharmaceutical initiates enrolment in a phase II pharmacodynamics trial for Non-small cell lung cancer (late-stage disease, second-line therapy or greater) in China (NCT02029209) Updated 15 Jan 2014
01 Dec 2013 Phase Change - II Phase-II clinical trials in Renal cell carcinoma (second-line therapy or greater, late-stage disease) in China (PO) (NCT02072044) Updated 05 Mar 2014
14 Aug 2013 Phase Change - II Phase-II clinical trials in Non-small cell lung cancer (second-line therapy or greater, late-stage disease) in China (PO) Updated 20 Aug 2013
01 Aug 2013 Phase Change - II Phase-II clinical trials in Cancer (Late-stage disease, Second-line therapy or greater) in China (PO) (NCT04216082) Updated 10 Jan 2020
01 Apr 2013 Phase Change - II Phase-II clinical trials in Soft tissue sarcoma (Second-line therapy or greater, Late-stage disease) in China (PO) (NCT01878448) Updated 04 Jul 2013
01 Apr 2013 Phase Change - II Phase-II clinical trials in Thyroid cancer (late-stage disease) in China (PO) Updated 04 Jul 2013
31 May 2011 Phase Change - I Phase-I clinical trials in Cancer (late-stage disease) in China (PO) (NCT01833923) Updated 14 May 2013

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