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Cemiplimab-Rwlc
Cemiplimab-Rwlc is a PD-1 inhibitor Small molecule drug developed by H. Lee Moffitt Cancer Center and Research Institute. It is currently FDA-approved for Cutaneous squamous cell carcinoma, Metastatic cutaneous squamous cell carcinoma. Also known as: Libtayo, REGN2810.
Cemiplimab-Rwlc is a monoclonal antibody that blocks PD-1 on immune cells, allowing them to recognize and attack cancer cells.
Cemiplimab-Rwlc is a programmed cell death protein 1 inhibitor, classified as an antibody inhibitor. It is being studied for the treatment of various types of head and neck squamous cell carcinoma, including head and neck squamous cell carcinoma, hypopharyngeal squamous cell carcinoma, laryngeal squamous cell carcinoma, nasal cavity squamous cell carcinoma, and oral cavity squamous cell carcinoma.
At a glance
| Generic name | Cemiplimab-Rwlc |
|---|---|
| Also known as | Libtayo, REGN2810 |
| Sponsor | H. Lee Moffitt Cancer Center and Research Institute |
| Drug class | PD-1 inhibitor |
| Target | PD-1 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
Mechanism of action
Cemiplimab-Rwlc binds to programmed death receptor 1 (PD-1) on T cells, preventing interaction with its ligands (PD-L1 and PD-L2) on tumor cells. This blockade releases the inhibitory signal that tumors use to evade immune surveillance, restoring T cell activation, proliferation, and anti-tumor cytotoxic function.
Approved indications
- Cutaneous squamous cell carcinoma
- Metastatic cutaneous squamous cell carcinoma
Common side effects
- Fatigue
- Diarrhea
- Nausea
- Rash
- Immune-mediated adverse events (pneumonitis, colitis, hepatitis)
Key clinical trials
- Testing Whether Cemiplimab (REGN2810) Plus CDX-1140 Given Prior to Surgery Are Better Than Cemiplimab (REGN2810) Alone in Patients With Stage III-IV Head and Neck Cancer (PHASE2)
- Testing the Effectiveness of the Anti-cancer Drug Pidnarulex (CX-5461) in Combination With Another Anti-cancer Drug Cemiplimab (REGN2810), in Treating Refractory Microsatellite Stable Colorectal Cancer (PHASE1, PHASE2)
- Testing the Addition of Chemotherapy or Chemo-Immunotherapy to the Usual Surgery for Advanced Head and Neck Cancer (PHASE2)
- Testing the Addition of an Immunotherapy Drug, Cemiplimab (REGN2810), Plus Surgery to the Usual Surgery Alone for Treating Advanced Skin Cancer (PHASE3)
- Testing the Combination of Anti-cancer Drugs Actimab-A and Cemiplimab (REGN2810) to Improve Outcomes for Patients With Recurrent Glioblastoma (PHASE1)
- A Vaccine (VSV-hIFNβ-NIS) With or Without Cyclophosphamide and Combinations of Ipilimumab, Nivolumab, and Cemiplimab in Treating Relapsed or Refractory Multiple Myeloma, Acute Myeloid Leukemia or Lymphoma (PHASE1)
- Testing the Addition of Cemiplimab (REGN2810) to Chemotherapy Treatment Given Prior to Surgery in Patients With Sinonasal Squamous Cell Carcinoma (PHASE2)
- Testing the Addition of an Anti-Cancer Drug, Cabozantinib to the Immunotherapy Drug Cemiplimab (REGN2810), in Adolescents and Adults With Advanced Adrenocortical Cancer (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:
- Cemiplimab-Rwlc CI brief — competitive landscape report
- Cemiplimab-Rwlc updates RSS · CI watch RSS
- H. Lee Moffitt Cancer Center and Research Institute portfolio CI
Frequently asked questions about Cemiplimab-Rwlc
What is Cemiplimab-Rwlc?
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Related
- Drug class: All PD-1 inhibitor drugs
- Target: All drugs targeting PD-1
- Manufacturer: H. Lee Moffitt Cancer Center and Research Institute — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Cutaneous squamous cell carcinoma
- Indication: Drugs for Metastatic cutaneous squamous cell carcinoma
- Also known as: Libtayo, REGN2810
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing