Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Fianlimab · 8 trials · 7 indications
Time from randomization to the first documented recurrence of disease at any site (excluding new primary melanomas) or death from any cause, whichever occurs first.
Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 based on Blinded Independent Central Review (BICR)
ORR is defined as confirmed complete response (CR) + confirmed partial response (PR) and will be determined as per RECIST 1.1.
Phase 2 ORR is defined as proportion of patients with a best overall response of confirmed complete response (CR) or partial response (PR).
Phase 3 Defined as the time from randomization to the date of death due to any cause
Proportion of patients with a best overall response of confirmed complete response (CR) or partial response (PR)
| Arm | Type | Description |
|---|---|---|
| fianlimab+cemiplimab | EXPERIMENTAL | Randomized 1:1 |
| relatlimab+nivolumab | ACTIVE_COMPARATOR | Randomized 1:1 |
| Fianlimab HD + Cemiplimab | EXPERIMENTAL | Patients will be administered one combination dose of fianlimab high dose (HD) and cemiplimab |
| Fianlimab LD + Cemiplimab | EXPERIMENTAL | Patients will be administered one combination dose of fianlimab low dose (LD) and cemiplimab |
| Pembrolizumab | ACTIVE_COMPARATOR | Patients will be administered one dose of pembrolizumab co-infused with saline/dextrose placebo |
| A: fianlimab+cemiplimab dose 1 | EXPERIMENTAL | As defined in Protocol Amendment 5 |
| A1: fianlimab+cemiplimab dose 2 | EXPERIMENTAL | As defined in Protocol Amendment 5 |
| B: pembrolizumab+placebo | EXPERIMENTAL | As defined in Protocol Amendment 5 |
| C: cemiplimab+placebo | EXPERIMENTAL | As defined in Protocol Amendment 5 |
| Arm A: Cemiplimab, Fianlimab, and Ipilimumab | EXPERIMENTAL | Cemiplimab and fianlimab will be co-administered by IV. Ipilimumab will be administered by IV. |
| Arm B: Cemiplimab and Fianlimab | EXPERIMENTAL | Cemiplimab and fianlimab will be co-administered by IV. |
| Arm C: Nivolumab and Ipilimumab | ACTIVE_COMPARATOR | Nivolumab and ipilimumab will be by IV. Nivolumab will be administered by IV after the combination. |
| With Disease Progression at Enrollment | OTHER | - |
| No Progressive Disease at Enrollment | OTHER | - |
| Arm A | EXPERIMENTAL | Randomized 1:1:1 Neoadjuvant period: placebo + cemiplimab + platinum doublet chemotherapy Adjuvant period: placebo + cemiplimab |
| Arm B | EXPERIMENTAL | Randomized 1:1:1 Neoadjuvant period: fianlimab high dose + cemiplimab + platinum doublet chemotherapy Adjuvant period: fianlimab high dose + cemiplimab |
| Arm C | EXPERIMENTAL | Randomized 1:1:1 Neoadjuvant period: fianlimab low dose + cemiplimab + platinum doublet chemotherapy Adjuvant Period: fianlimab low dose + cemiplimab |
| Phase 2 - Arm A | EXPERIMENTAL | Randomized 1:1:1 fianlimab (higher dose) + cemiplimab + platinum-doublet chemotherapy |
| Phase 2 - Arm B | EXPERIMENTAL | Randomized 1:1:1 fianlimab (lower dose) + cemiplimab + platinum-doublet chemotherapy |
| Phase 2 - Arm C | EXPERIMENTAL | Randomized 1:1:1 cemiplimab + platinum-doublet chemotherapy + placebo |
| Phase 3 - Arm A or B | EXPERIMENTAL | Randomized 1:1 fianlimab (chosen dose) + cemiplimab + platinum-doublet chemotherapy |
| Phase 3 - Arm C | EXPERIMENTAL | Randomized 1:1 cemiplimab + platinum-doublet chemotherapy + placebo |
| A: fianlimab+cemiplimab | EXPERIMENTAL | Phase 2: fianlimab (HD) |
| B: fianlimab+cemiplimab | EXPERIMENTAL | Phase 2: fianlimab (LD) |
| C: cemiplimab monotherapy+placebo | EXPERIMENTAL | Phase 2 |
| Name | Type | Description |
|---|---|---|
| fianlimab | DRUG | Intravenous (IV) administration every 3 weeks (Q3W) in combination with cemiplimab |
| cemiplimab | DRUG | IV administration Q3W in combination with fianlimab |
| relatlimab+nivolumab | DRUG | IV administration every 4 weeks (Q4W) |
| Pembrolizumab | DRUG | Pembrolizumab will be administered by IV infusion Q 3 weeks |
| Placebo | DRUG | Matching placebo co-infused with pembrolizumab IV, will be administered by IV infusion Q 3 weeks |
| Ipilimumab | DRUG | Ipilimumab will be administered by IV. |
| Nivolumab | DRUG | Nivolumab will be administered by IV. Maintenance nivolumab will then be administered by IV. |
| Fianlimab+cemiplimab | DRUG | No study drug administered in this observational study. |
| Pemetrexed | DRUG | Administered IV Q3W |
| Paclitaxel | DRUG | Administered IV Q3W |
| Carboplatin | DRUG | Administered IV Q3W |
| Cisplatin | DRUG | Administered IV Q3W |
Key Inclusion Criteria: 1. Participants with histologically confirmed unresectable stage III and stage IV (metastatic) melanoma per American Joint Committee on Cancer (AJCC), eighth revised edition. 2. Participants must not have received prior systemic therapy for unresectable or metastatic melanom...
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Fianlimab is an investigational oncology drug being studied for advanced non-small cell lung cancer, head and neck squamous cell carcinoma, resectable non-small cell lung cancer, advanced renal cell carcinoma, and melanoma. It is being evaluated in combination with cemiplimab in Phase 2 clinical trials.
Fianlimab targets LAG3, a protein involved in immune regulation, and acts as an inhibitor of this target. By inhibiting LAG3, it is designed to modulate the immune system's response to cancer cells, potentially enhancing anti-tumor activity when combined with other therapies.
Fianlimab is being developed by Regeneron Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol REGN. The company is conducting multiple clinical trials to evaluate the drug's safety and efficacy in various cancer indications.
Fianlimab is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials to determine its safety and effectiveness for treating cancer.
Fianlimab is being studied in four active Phase 2 trials. These include NCT05785767 and NCT05800015 for advanced non-small cell lung cancer, NCT06161441 for resectable non-small cell lung cancer, and NCT06769698 for head and neck squamous cell carcinoma. All trials combine fianlimab with cemiplimab.
Fianlimab is a single drug, while fianlimab plus cemiplimab is a combination therapy being studied in clinical trials. The combination is often referred to as FDC fianlimab+cemiplimab or simply fianlimab+cemiplimab, and it is the regimen being evaluated across all current Phase 2 trials.