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Pembrolizumab Monotherapy
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 Melanoma (unresectable or metastatic), Non-small cell lung cancer (metastatic, PD-L1 positive), Head and neck squamous cell carcinoma (recurrent or metastatic).
At a glance
| Generic name | Pembrolizumab Monotherapy |
|---|---|
| Also known as | KEYTRUDA, Keytruda |
| Sponsor | PDS Biotechnology Corp. |
| 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 and immune cells. This blockade releases the 'brakes' on T-cell-mediated immunity, restoring anti-tumor immune responses. The drug is used as monotherapy in various cancers where PD-L1 expression or tumor microenvironment characteristics predict responsiveness.
Approved indications
- Melanoma (unresectable or metastatic)
- Non-small cell lung cancer (metastatic, PD-L1 positive)
- Head and neck squamous cell carcinoma (recurrent or metastatic)
- Hodgkin lymphoma (relapsed or refractory)
- Urothelial carcinoma (locally advanced or metastatic)
- Gastric or gastroesophageal junction adenocarcinoma (PD-L1 positive)
Common side effects
- Fatigue
- Decreased appetite
- Nausea
- Diarrhea
- Rash
- Immune-mediated pneumonitis
- Immune-mediated colitis
- Immune-mediated hepatitis
- Immune-mediated endocrinopathy
Key clinical trials
- Study BT8009-230 in Participants With Locally Advanced or Metastatic Urothelial Cancer (Duravelo-2) (PHASE2, PHASE3)
- 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 Clinical Study of MK-4716 in People With Certain Solid Tumors (MK-4716-001) (PHASE1)
- A Study of (Neo)Adjuvant Intismeran Autogene (V940) and Pembrolizumab in Cutaneous Squamous Cell Carcinoma (V940-007) (PHASE2, PHASE3)
- Pembrolizumab With or Without Maintenance Sacituzumab Tirumotecan (Sac-TMT; MK-2870) in Metastatic Squamous Non-small Cell Lung Cancer (NSCLC) [MK-2870-023] (PHASE3)
- A Clinical Study to Evaluate the Safety, Tolerability and Efficacy of IOS-1002 Administered Alone and in Combination With Pembrolizumab, a PD-1 Monoclonal Antibody in Advanced Solid Tumors (PHASE1)
- A Study to Evaluate the Efficacy of Pumitamig Versus Pembrolizumab in Participants With Previously Untreated Advanced Non-Small Cell Lung Cancer and PD-L1 ≥ 50%. (ROSETTA Lung-202) (PHASE3)
- A Global Phase III Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for First-Line Treatment of Metastatic Non-squamous NSCLC (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 Monotherapy CI brief — competitive landscape report
- Pembrolizumab Monotherapy updates RSS · CI watch RSS
- PDS Biotechnology Corp. portfolio CI