Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as REGN3767
Fianlimab · 10 trials · 9 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. |
| 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. |
| 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 |
| Monotherapy (REGN3767) | EXPERIMENTAL | Group A will consist of up to 4 sequential dose cohorts. Each cohort will receive 1 of 3 ascending dose levels of study drug during dose escalation. In addition 1 tumor-specific cohort will be treated at the recommended phase 2 dose (RP2D) during dose expansion. |
| Combination Therapy (REGN3767+cemiplimab) | EXPERIMENTAL | Group B will consist of up to 4 sequential dose cohorts. Each cohort will receive 1 of 3 ascending dose levels of study drug during dose escalation. In addition, 9 tumor-specific cohorts will be treated at the RP2D during dose expansion |
| 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. |
| FDC fianlimab+cemiplimab | DRUG | Fixed-Dose Combination (FDC) Administered per the protocol |
| 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 |
| REGN3767 | DRUG | - |
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 monoclonal antibody developed by Regeneron Pharmaceuticals that targets LAG3, an inhibitory immune checkpoint. It is being studied in oncology, both as a single agent and in combination with cemiplimab, an anti-PD-1 antibody, across several solid tumor types including melanoma, non-small cell lung cancer, renal cell carcinoma, and head and neck squamous cell carcinoma.
Fianlimab targets LAG3 (lymphocyte activation gene 3), an inhibitory immune checkpoint receptor on immune cells. Fianlimab is a LAG3 inhibitor, meaning it is designed to block LAG3-mediated suppression of immune responses. It is being developed both alone and combined with cemiplimab, an anti-PD-1 antibody, in solid tumors.
Fianlimab is developed by Regeneron Pharmaceuticals, Inc., which trades under the ticker REGN. Regeneron is running the clinical program for fianlimab, including studies that combine it with cemiplimab, the company's anti-PD-1 antibody, in melanoma, head and neck cancer, renal cell carcinoma, and lung cancer.
Fianlimab is in Phase 2 clinical development across most of its programs, with a Phase 3 study also recruiting in advanced or metastatic melanoma. It is investigational and is not described as approved. The program includes four active trials with a combined planned enrollment of 3,718 participants, and the studies are randomized, double-blind, and controlled.
Fianlimab is being studied in four active trials. These include NCT07188896 in first-line advanced renal cell carcinoma, NCT06769698 in recurrent or metastatic head and neck squamous cell carcinoma, NCT06246916 (Harmony Head-to-Head) in advanced or metastatic melanoma, and NCT06848088, a long-term follow-up study of melanoma participants from a prior trial.