Pembrolizumab - Merck & Co

Drug Profile

Pembrolizumab - Merck & Co

Alternative Names: Anti-PD-1 monoclonal antibody - Merck; Humanised monoclonal IgG4 antibody against PD-1 - Merck; Keytruda; Lambrolizumab; MK-3475; SCH-900475

Latest Information Update: 11 Apr 2018

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At a glance

  • Originator Merck & Co; The Leukemia & Lymphoma Society
  • Developer Aduro BioTech; Amgen; Augusta University; BerGenBio; Big Ten Cancer Research Consortium; BioLineRx; Canadian Cancer Trials Group; Columbia University; Dana-Farber Cancer Institute; DNAtrix; Eisai Co Ltd; Eli Lilly; Fox Chase Cancer Center; Genexine; Gilead Sciences; H. Lee Moffitt Cancer Center and Research Institute; Hoosier Cancer Research Network; Icahn School of Medicine at Mount Sinai; ImmunoGen; Incyte Corporation; Institute of Cancer Research; M. D. Anderson Cancer Center; Massachusetts General Hospital; Mayo Clinic; Memorial Sloan-Kettering Cancer Center; Merck & Co; Merck Sharp & Dohme; National Cancer Institute (France); National Cancer Institute (USA); Netherlands Cancer Institute; Northwestern University; NYU Langone Medical Center; Oslo University Hospital; Plexxikon; Providence Health & Services; Royal Marsden NHS Foundation Trust; Sarcoma Alliance for Research through Collaboration; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; Spanish Breast Cancer Research Group; Syndax Pharmaceuticals; TG Therapeutics Inc; University Health Network; University of Alabama; University of Birmingham; University of California at San Francisco; University of California, San Diego; University of Colorado at Denver; University of Pittsburgh; University of Utah; Verastem; Washington University School of Medicine; Yale University
  • Class Antineoplastics; Immunotherapies; Monoclonal antibodies
  • Mechanism of Action Programmed cell death-1 receptor antagonists
  • Orphan Drug Status

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

  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Colorectal cancer; Head and neck cancer; Hodgkin's disease; Malignant melanoma; Non-small cell lung cancer; Pancreatic cancer; Solid tumours; Urogenital cancer
  • Registered Cancer; Gastric cancer
  • Preregistration Cervical cancer; Diffuse large B cell lymphoma
  • Phase III Breast cancer; Gastrointestinal cancer; Hepatocellular carcinoma; Liver cancer; Mesothelioma; Multiple myeloma; Oesophageal cancer; Renal cell carcinoma; Small cell lung cancer
  • Phase II Acute myeloid leukaemia; Adenocarcinoma; Bladder cancer; Bone cancer; Brain metastases; Cholangiocarcinoma; Endometrial cancer; Fallopian tube cancer; Follicular lymphoma; Germ cell and embryonal neoplasms; Glioblastoma; Glioma; Inflammatory breast cancer; Lymphoma; Meningioma; Merkel cell carcinoma; Myelodysplastic syndromes; Nasopharyngeal cancer; Neuroendocrine tumours; Non-Hodgkin's lymphoma; Osteosarcoma; Ovarian cancer; Penile cancer; Peritoneal cancer; Prostate cancer; Rectal cancer; Recurrent respiratory papillomatosis; Sarcoma; Soft tissue sarcoma; Squamous cell cancer; Thymoma; Thyroid cancer; Uveal melanoma
  • Phase I/II Chronic lymphocytic leukaemia; Leiomyosarcoma; Mantle-cell lymphoma; Precursor cell lymphoblastic leukaemia-lymphoma; T cell lymphoma
  • Phase I Gliosarcoma
  • Preclinical Human papillomavirus infections
  • No development reported Haematological malignancies

Most Recent Events

  • 10 Apr 2018 Interim efficacy data from the phase III KEYNOTE-042 trial in Non-small cell lung cancer released by Merck
  • 06 Apr 2018 Incyte and Merck terminate the phase III KEYNOTE-252 trial in Malignant melanoma (Combination therapy, First-line therapy, Inoperable/Unresectable, Late-stage disease, Metastatic disease) in USA, United Kingdom, Netherlands, Switzerland, South Africa, Russia, Poland, New Zealand, Mexico, South Korea, Italy, Israel, Ireland, Germany, France, Denmark, Chile, Canada, Belgium, Australia, Spain and Sweden (PO) (NCT02752074)
  • 03 Apr 2018 Merck Sharp & Dohme plans the phase I/II KEYNOTE-587 trial for Solid tumours (Late-stage disease, Inoperable/Unresectable, Metastatic disease) (IV) (NCT03486873)
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