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Also known as Fianlimab, fianlimab
fianlimab+cemiplimab · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | Approximately 60 participants with HPV (human papillomavirus) positive HNSCC. Randomized 1:1 to Fianlimab + Cemiplmab Fixed Dose Combination (FDC) versus Cemiplimab + Placebo. |
| Cohort 2 | EXPERIMENTAL | Approximately 60 participants with HPV negative HNSCC. Randomization is the same as in Cohort 1. |
| Name | Type | Description |
|---|---|---|
| FDC fianlimab+cemiplimab | DRUG | Fixed-Dose Combination (FDC) Administered per the protocol |
| Cemiplimab | DRUG | Administered per the protocol |
| Placebo | DRUG | Administered per the protocol |
Key Inclusion Criteria: 1. Have histologically confirmed (by local pathology) R/M HNSCC that is considered incurable by local therapies 2. Primary tumor location of oral cavity, oropharynx, larynx, or hypopharynx (patients with cervical neck node SCC with occult primary as described in the protocol...
Fianlimab is an investigational antibody being studied for the treatment of several cancers, including melanoma, advanced renal cell carcinoma, non-small cell lung cancer, and head and neck squamous cell carcinoma. It is being evaluated in clinical trials, often in combination with cemiplimab, for these oncology indications.
Fianlimab is a monoclonal antibody, indicated by its -mab suffix, that is being studied as a cancer immunotherapy. It is designed to be used in combination with cemiplimab for the treatment of various solid tumors, including melanoma and advanced renal cell carcinoma.
Fianlimab is being developed by Regeneron Pharmaceuticals, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol REGN. Regeneron is conducting clinical trials of fianlimab, often in combination with its other investigational or approved agents, for multiple oncology indications.
Fianlimab is in Phase 2 and Phase 3 clinical trials. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical development to assess its safety and efficacy in treating various cancers.
Fianlimab is being studied in several clinical trials. One Phase 3 trial (NCT05352672) compares fianlimab plus cemiplimab versus pembrolizumab in previously untreated advanced melanoma. Another Phase 3 trial (NCT05608291) tests the combination for preventing melanoma recurrence after surgery. A Phase 2 trial (NCT07188896) is evaluating fianlimab and cemiplimab with or without ipilimumab in first-line advanced renal cell carcinoma.
Fianlimab is a single drug, while fianlimab plus cemiplimab is a combination regimen. In clinical trials, fianlimab is often studied in combination with cemiplimab, and this combination is sometimes referred to as fianlimab+cemiplimab. The two drugs are distinct agents that are being evaluated together for cancer treatment.