Trial Profile
A Randomized, Controlled, Open-label, Global Phase 3 Study Comparing the Efficacy of the Anti-PD-1 Antibody BGB-A317 Versus Chemotherapy as Second Line Treatment in Patients With Advanced Unresectable/Metastatic Esophageal Squamous Cell Carcinoma
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 18 Mar 2024
Price :
$35
*
At a glance
- Drugs Tislelizumab (Primary) ; Docetaxel; Irinotecan; Paclitaxel
- Indications Oesophageal cancer; Squamous cell cancer
- Focus Registrational; Therapeutic Use
- Acronyms RATIONALE 302
- Sponsors BeiGene
- 14 Mar 2024 According to a BeiGene media release, company announced that the U.S. Food and Drug Administration (FDA) has approved TEVIMBRA (tislelizumab-jsgr) as monotherapy for the treatment of adult patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor based on the RATIONALE 302 trial.
- 27 Feb 2024 According to a BeiGene media release, company to submit a marketing application with the Japan PMDA for the treatment of first- and second-line ESCC in the first half of 2024.
- 26 Feb 2024 According to a BeiGene media release, company to receive FDA approval for the treatment of second-line ESCC in first half of 2024 with a target PDUFA in July 2024