Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication LIBTAYO is a programmed death receptor-1 (PD-1) blocking antibody indicated: Cutaneous Squamous Cell Carcinoma (CSCC) for the treatment of adult patients with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation. FDA label
Also known as fianlimab, REGN2810, Libtayo®, Anti-LAG-3 MoAb
REGN3767 · 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...
REGN3767 is an investigational monoclonal antibody developed by Regeneron Pharmaceuticals, Inc. for the treatment of malignancies. It is designed to target LAG-3, a protein that regulates immune cell activity. REGN3767 has been studied in a Phase 1 clinical trial in patients with advanced cancers, both as a single agent and in combination with REGN2810, an anti-PD-1 antibody.
REGN3767 targets LAG-3, a protein found on the surface of certain immune cells. LAG-3 acts as an inhibitory checkpoint that can suppress T-cell responses. By binding to LAG-3, REGN3767 is designed to block this inhibitory signal and potentially enhance the immune system's ability to recognize and attack cancer cells.
REGN3767 is being developed by Regeneron Pharmaceuticals, Inc., a biotechnology company traded on the Nasdaq under the ticker symbol REGN. Regeneron is the sponsor of the clinical trial evaluating REGN3767 in patients with advanced malignancies.
REGN3767 is in Phase 1 clinical development. It is an investigational agent and has not been approved by the FDA for any indication. The Phase 1 trial evaluating REGN3767 has been completed, and the drug remains in early-stage clinical research for the treatment of malignancies.
REGN3767 has been evaluated in a Phase 1 clinical trial, NCT03005782, titled "Study of REGN3767 (Anti-LAG-3) With or Without REGN2810 (Anti-PD1) in Advanced Cancers." The trial enrolled 333 patients with malignancies across the United States, Australia, Ireland, South Korea, and the United Kingdom, and its status is completed.