# Fianlimab

Source: https://onco.cc/drugs/fianlimab/  
OnCo record `fianlimab` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Fianlimab is Regeneron's LAG-3 blocking antibody, paired with the PD-1 blocker cemiplimab. A 60% phase 1 response rate in untreated melanoma prompted phase 3 trials, but the metastatic trial against pembrolizumab missed its progression endpoint in 2026.

## Summary

Phase 1 with cemiplimab reported ORR ~60% in first-line melanoma, prompting phase 3 trials versus pembrolizumab in metastatic disease (missed PFS, 2026) and in the adjuvant setting (ongoing). Also being tested in NSCLC. The result narrows the LAG-3 story to the specific nivolumab-relatlimab pairing so far.

## Fields

- Kind: Treatment
- Status: phase-3
- Last checked: 2026-09-07
- Tags: failed-so-far
- Code: REGN3767
- Modality: Monoclonal antibody (anti-LAG-3)
- Mechanism: Fully human IgG4 blocking LAG-3 binding to MHC class II and FGL1.

## Sources

- Regeneron update: https://investor.regeneron.com/news-releases/news-release-details/regeneron-provides-update-phase-3-trial-fianlimab-lag-3

## Connected records

- cancers: [Advanced melanoma (unresectable stage III and stage IV)](https://onco.cc/cancers/advanced-melanoma/), [Melanoma](https://onco.cc/cancers/melanoma/), [Skin cancer (all types)](https://onco.cc/cancers/skin-cancer/)
- technologies: [Immune checkpoint inhibitors](https://onco.cc/technologies/checkpoint-inhibitor/)
- targets: [LAG-3](https://onco.cc/targets/lag3/)
- drugs: [Cemiplimab](https://onco.cc/drugs/cemiplimab/)
- companies: [Regeneron](https://onco.cc/companies/regeneron/)
- trials: [A Phase II Platform Study to Evaluate Treatment With Cemiplimab Monotherapy or Cemiplimab Plus Fianlimab or Other Novel Combinations in Patients With Colorectal](https://onco.cc/trials/nct07058012/), [A Study to Learn if a Combination of Fianlimab and Cemiplimab Versus Cemiplimab Alone is More Effective for Adult Participants With Advanced Non-Small](https://onco.cc/trials/nct05785767/), [A Study to See if Giving Fianlimab and Cemiplimab Together is Better Than Cemiplimab Alone at Treating Recurrent or Metastatic Head and Neck Squamous ](https://onco.cc/trials/nct06769698/), [A Study With Combinations of Anti-LAG-3 and Anti-PD-1 Antibodies in Adult Participants With Advanced or Metastatic Melanoma (Harmony Head-to-Head)](https://onco.cc/trials/nct06246916/), [A Trial to Learn How the Combination of Fianlimab With Cemiplimab and Chemotherapy Works Compared With Cemiplimab and Chemotherapy for Treating Adult ](https://onco.cc/trials/nct05800015/), [A Trial to Learn if Fianlimab and Cemiplimab Are Safe and Work Better Than Anti-PD1 Alone in Adult Participants With Resectable Stage 3 or 4 Melanoma](https://onco.cc/trials/nct06190951/), [A Trial to Learn if the Combination of Fianlimab, Cemiplimab, and Chemotherapy is Safe and Works Better Than the Combination of Cemiplimab and Chemoth](https://onco.cc/trials/nct06161441/), [A Trial to See if the Combination of Fianlimab With Cemiplimab Works Better Than Pembrolizumab for Preventing or Delaying Melanoma From Coming Back Af](https://onco.cc/trials/nct05608291/), [Capecitabine/Oxaliplatin Chemotherapy and Cemiplimab With or Without Fianlimab or REGN7075 in Locally Advanced Rectal Cancer](https://onco.cc/trials/nct07281768/), [Cemiplimab With or Without Fianlimab to Treat Older Patients With Localized or Locally Advanced MSI-H Colorectal Cancer](https://onco.cc/trials/nct06205836/), [Fianlimab + cemiplimab phase 3 (first-line melanoma)](https://onco.cc/trials/fianlimab-phase3-melanoma/), [I-SPY 2](https://onco.cc/trials/i-spy-2/), [Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer](https://onco.cc/trials/nct06787612/), [Neoadjuvant Cemiplimab for the Treatment of Resectable NSCLC, HCC, and HNSCC in Adult Patients](https://onco.cc/trials/nct03916627/), [Thoracic Radiotherapy and Inhibition of PD-1 and LAG-3 for Locally Advanced Non-Small Cell Lung Cancer](https://onco.cc/trials/nct06865339/)
- pairings: [Caution: LAG-3 blockade outside active disease](https://onco.cc/pairings/lag3-adjuvant-caution/)
- pathways: [T-cell exhaustion](https://onco.cc/pathways/t-cell-exhaustion/)

---
JSON: https://onco.cc/api/v1/entities/fianlimab.json