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Pembrolizumab Formulated with Berahyaluronidase Alfa
Pembrolizumab Formulated with Berahyaluronidase Alfa is a PD-1 inhibitor with recombinant human hyaluronidase Biologic drug developed by Merck Sharp & Dohme LLC. It is currently in Phase 3 development for Melanoma (advanced or metastatic), Non-small cell lung cancer (metastatic, PD-L1 positive), Head and neck squamous cell carcinoma. Also known as: MK-3475A.
Pembrolizumab blocks PD-1 on immune cells to restore anti-tumor immunity, while berahyaluronidase alfa enhances subcutaneous drug delivery by temporarily degrading hyaluronic acid in tissue.
Pembrolizumab blocks PD-1 on immune cells to restore anti-tumor immunity, while berahyaluronidase alfa enhances subcutaneous drug delivery by temporarily degrading hyaluronic acid in tissue. Used for Melanoma (advanced or metastatic), Non-small cell lung cancer (metastatic, PD-L1 positive), Head and neck squamous cell carcinoma.
At a glance
| Generic name | Pembrolizumab Formulated with Berahyaluronidase Alfa |
|---|---|
| Also known as | MK-3475A |
| Sponsor | Merck Sharp & Dohme LLC |
| Drug class | PD-1 inhibitor with recombinant human hyaluronidase |
| Target | PD-1; hyaluronic acid (via berahyaluronidase alfa) |
| Modality | Biologic |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Pembrolizumab is a PD-1 checkpoint inhibitor that prevents tumor cells from suppressing T-cell responses, thereby reactivating the immune system to attack cancer. Berahyaluronidase alfa is a recombinant human hyaluronidase that transiently breaks down hyaluronic acid in the subcutaneous space, increasing the bioavailability and absorption of co-administered pembrolizumab, allowing for subcutaneous administration instead of intravenous infusion.
Approved indications
- Melanoma (advanced or metastatic)
- Non-small cell lung cancer (metastatic, PD-L1 positive)
- Head and neck squamous cell carcinoma
- Hodgkin lymphoma (classical, relapsed or refractory)
- Gastric or gastroesophageal junction adenocarcinoma
- Cervical cancer
- Renal cell carcinoma
- Endometrial carcinoma
- Microsatellite instability-high or mismatch repair-deficient solid tumors
Common side effects
- Fatigue
- Diarrhea
- Nausea
- Decreased appetite
- Rash
- Pruritus
- Immune-mediated pneumonitis
- Immune-mediated colitis
- Immune-mediated hepatitis
- Immune-mediated endocrinopathy (thyroiditis, adrenalitis)
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 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 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:
- Pembrolizumab Formulated with Berahyaluronidase Alfa CI brief — competitive landscape report
- Pembrolizumab Formulated with Berahyaluronidase Alfa updates RSS · CI watch RSS
- Merck Sharp & Dohme LLC portfolio CI
Frequently asked questions about Pembrolizumab Formulated with Berahyaluronidase Alfa
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Related
- Drug class: All PD-1 inhibitor with recombinant human hyaluronidase drugs
- Target: All drugs targeting PD-1; hyaluronic acid (via berahyaluronidase alfa)
- Manufacturer: Merck Sharp & Dohme LLC — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Melanoma (advanced or metastatic)
- Indication: Drugs for Non-small cell lung cancer (metastatic, PD-L1 positive)
- Indication: Drugs for Head and neck squamous cell carcinoma
- Also known as: MK-3475A
- Compare: Pembrolizumab Formulated with Berahyaluronidase Alfa vs similar drugs
- Pricing: Pembrolizumab Formulated with Berahyaluronidase Alfa cost, discount & access