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MK-3475A
MK-3475A is a PD-1 inhibitor that blocks the interaction between PD-1 on T cells and its ligands, thereby enhancing anti-tumor immune responses.
MK-3475A is a PD-1 inhibitor that blocks the interaction between PD-1 on T cells and its ligands, thereby enhancing anti-tumor immune responses. Used for Advanced or metastatic melanoma, Non-small cell lung cancer, Head and neck squamous cell carcinoma.
At a glance
| Generic name | MK-3475A |
|---|---|
| Also known as | Pembrolizumab (+) Berahyaluronidase alfa |
| Sponsor | Merck Sharp & Dohme LLC |
| Drug class | PD-1 inhibitor |
| Target | PD-1 |
| Modality | Biologic |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
By inhibiting the PD-1 checkpoint, MK-3475A prevents tumor cells from suppressing T cell activity, allowing the immune system to recognize and attack cancer cells more effectively. This mechanism restores exhausted T cell function and promotes durable anti-tumor immunity. The drug is designed as a next-generation or optimized variant of pembrolizumab (MK-3475).
Approved indications
- Advanced or metastatic melanoma
- Non-small cell lung cancer
- Head and neck squamous cell carcinoma
- Hodgkin lymphoma
- Gastric or gastroesophageal junction adenocarcinoma
Common side effects
- Fatigue
- Diarrhea
- Nausea
- Decreased appetite
- Immune-mediated pneumonitis
- Immune-mediated colitis
- Immune-mediated hepatitis
- Immune-mediated endocrinopathy
Key clinical trials
- A Study to Evaluate the Bioavailability of Pembrolizumab (MK-3475) Via Subcutaneous (SC) Injection of Pembrolizumab Formulated With Berahyaluronidase Alfa (MK-5180) [MK-3475A] In Advanced Solid Tumors (MK-3475A-C18) (PHASE1)
- A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007) (PHASE3)
- MK-3475A±MK-1084 in Completely Resected Stage IIA-IIIB (N2) KRAS G12Cm NSCLC (MK-1084-013) (PHASE3)
- A Study of Pembrolizumab (+) Berahyaluronidase Alfa (MK-3475A) (Pembrolizumab Formulated With Berahyaluronidase Alfa (MK-5180)) in Japanese Participants With Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma (R/M cSCC) or Locally Advanced (LA) Unresectable cSCC (MK-3475A-E39) (PHASE2)
- A Clinical Study of Pembrolizumab (+) Berahyaluronidase Alfa (MK-3475A) to Treat Newly-diagnosed Metastatic Non-small Cell Lung Cancer (MK-3475A-F84) (PHASE3)
- A Study to Evaluate the Safety and Efficacy of Pembrolizumab (MK-3475) Coformulated With Berahyaluronidase Alfa (MK-3475A) in Participants With Relapsed or Refractory Classical Hodgkin Lymphoma (rrcHL) or Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL)(MK-3475A-F65) (PHASE2)
- A Study of Subcutaneous (SC) Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) vs Intravenous Pembrolizumab in Adult Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) (MK-3475A-D77)-Japan Extension (PHASE3)
- A Study of Subcutaneous (SC) Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) vs Intravenous Pembrolizumab in Adult Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) (MK-3475A-D77) (PHASE3)
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:
- MK-3475A CI brief — competitive landscape report
- MK-3475A updates RSS · CI watch RSS
- Merck Sharp & Dohme LLC portfolio CI