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Pembrolizumab (MK-3475)
Pembrolizumab is a monoclonal antibody that blocks PD-1 on T cells, allowing the immune system to recognize and attack cancer cells.
Pembrolizumab is a monoclonal antibody that blocks PD-1 on T cells, allowing the immune system to recognize and attack cancer cells. Used for Metastatic melanoma, Non-small cell lung cancer (NSCLC), Head and neck squamous cell carcinoma.
At a glance
| Generic name | Pembrolizumab (MK-3475) |
|---|---|
| Also known as | KEYTRUDA®, MK-3475, Keytruda |
| Sponsor | Memorial Sloan Kettering Cancer Center |
| Drug class | PD-1 inhibitor |
| Target | PD-1 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Pembrolizumab binds to programmed death receptor 1 (PD-1) on T lymphocytes, preventing interaction with its ligands PD-L1 and PD-L2 on tumor cells. This blockade releases the 'brakes' on anti-tumor immunity, restoring T cell proliferation, activation, and cytotoxic function. By reinvigorating exhausted T cells, pembrolizumab enables durable anti-tumor responses.
Approved indications
- Metastatic melanoma
- Non-small cell lung cancer (NSCLC)
- Head and neck squamous cell carcinoma
- Hodgkin lymphoma
- Urothelial carcinoma
- Gastric cancer
- Cervical cancer
- Microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors
Common side effects
- Fatigue
- Decreased appetite
- Nausea
- Diarrhea
- Immune-related pneumonitis
- Immune-related hepatitis
- Immune-related colitis
- Hypothyroidism
- Rash
Key clinical trials
- Pembrolizumab Plus CA-4948 for the Treatment of Patients With Progressive Metastatic Urothelial Cancer Despite Prior Immunotherapy (PHASE1)
- Study BT8009-230 in Participants With Locally Advanced or Metastatic Urothelial Cancer (Duravelo-2) (PHASE2, PHASE3)
- Combining Immunotherapy and Radiation Therapy to Help Patients Avoid Bladder Removal After Treatment Shrinks Muscle Invasive Bladder Cancer, BRIGHT Trial (PHASE2)
- A Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Participants With Triple-Negative Breast Cancer (MK-2870-011/TroFuse-011) (PHASE3)
- A Phase II Study of Futibatinib and Pembrolizumab in Metastatic Microsatellite Stable Endometrial Carcinoma (PHASE2)
- A Clinical Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in People With Breast Cancer (MK-2870-032) (PHASE3)
- Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I) (PHASE1)
- BLAST MRD AML-2: BLockade of PD-1 Added to Standard Therapy to Target Measurable Residual Disease in Acute Myeloid Leukemia 2- A Randomized Phase 2 Study of Anti-PD-1 Pembrolizumab in Combination With Azacitidine and Venetoclax as Frontline Therapy in Unfit Patients With Acute Myeloid Leukemia (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Pembrolizumab (MK-3475) CI brief — competitive landscape report
- Pembrolizumab (MK-3475) updates RSS · CI watch RSS
- Memorial Sloan Kettering Cancer Center portfolio CI