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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.
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.
Fully human IgG4 blocking LAG-3 binding to MHC class II and FGL1. Connects to LAG-3.
1.Blocks LAG-3 on exhausted T cells
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First-line metastatic phase 3 missed its primary PFS endpoint (Regeneron release)
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Query for this drug: (TITLE:"Fianlimab" OR ABSTRACT:"Fianlimab" OR TITLE:"REGN3767" OR ABSTRACT:"REGN3767") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Fianlimab, not a curated reading list.
Shares T-cell exhaustion, Immune checkpoint inhibitors and the tag failed-so-far.
Shares Caution: LAG-3 blockade outside active disease, Fianlimab + cemiplimab phase 3 (first-line melanoma), LAG-3, Advanced melanoma (unresectable stage III and stage IV).
Shares Caution: LAG-3 blockade outside active disease, 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), LAG-3, T-cell exhaustion.
Shares A Phase II Platform Study to Evaluate Treatment With Cemiplimab Monotherapy or Cemiplimab Plus Fianlimab or Other Novel Combinations in Patients With Colorectal, Capecitabine/Oxaliplatin Chemotherapy and Cemiplimab With or Without Fianlimab or REGN7075 in Locally Advanced Rectal Cancer, Regeneron.
Shares Caution: LAG-3 blockade outside active disease, LAG-3, Melanoma, Immune checkpoint inhibitors.
Shares Regeneron, Cemiplimab, Melanoma, Immune checkpoint inhibitors.
Shares LAG-3, Advanced melanoma (unresectable stage III and stage IV), Melanoma, Immune checkpoint inhibitors.
Shares Regeneron, Cemiplimab, Skin cancer (all types), Immune checkpoint inhibitors.