{"entity":{"id":"fianlimab","kind":"drug","name":"Fianlimab","aka":[],"tldr":"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.","status":"phase-3","asOf":"2026-09-07","links":[{"label":"Regeneron update","url":"https://investor.regeneron.com/news-releases/news-release-details/regeneron-provides-update-phase-3-trial-fianlimab-lag-3"}],"tags":["failed-so-far"],"related":[],"cancers":["melanoma"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":["lag3"],"drugs":["cemiplimab"],"companies":["regeneron"],"institutions":[],"pathways":[],"terms":[],"trials":["fianlimab-phase3-melanoma","nct06246916","nct05800015","nct05608291","nct05785767","nct06161441","nct03916627","nct06190951","nct06769698"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"code":"REGN3767","modality":"Monoclonal antibody (anti-LAG-3)","mechanism":"Fully human IgG4 blocking LAG-3 binding to MHC class II and FGL1.","approvals":[],"mechanismSteps":["Blocks LAG-3 on exhausted T cells","With PD-1 blockade, aims to restore effector function in doubly inhibited T cells"],"toxicity":[],"access":[],"regulatoryEvents":[{"date":"2026","type":"designation","region":"US","note":"First-line metastatic phase 3 missed its primary PFS endpoint (Regeneron release)"}]},"route":"/drugs/fianlimab/","neighbours":{"cancer":[{"id":"advanced-melanoma","kind":"cancer","name":"Advanced melanoma (unresectable stage III and stage IV)","route":"/cancers/advanced-melanoma/"},{"id":"melanoma","kind":"cancer","name":"Melanoma","route":"/cancers/melanoma/"},{"id":"skin-cancer","kind":"cancer","name":"Skin cancer (all types)","route":"/cancers/skin-cancer/"}],"technology":[{"id":"checkpoint-inhibitor","kind":"technology","name":"Immune checkpoint inhibitors","route":"/technologies/checkpoint-inhibitor/"}],"target":[{"id":"lag3","kind":"target","name":"LAG-3","route":"/targets/lag3/"}],"drug":[{"id":"cemiplimab","kind":"drug","name":"Cemiplimab","route":"/drugs/cemiplimab/"}],"company":[{"id":"regeneron","kind":"company","name":"Regeneron","route":"/companies/regeneron/"}],"trial":[{"id":"nct07058012","kind":"trial","name":"A Phase II Platform Study to Evaluate Treatment With Cemiplimab Monotherapy or Cemiplimab Plus Fianlimab or Other Novel Combinations in Patients With Colorectal","route":"/trials/nct07058012/"},{"id":"nct05785767","kind":"trial","name":"A Study to Learn if a Combination of Fianlimab and Cemiplimab Versus Cemiplimab Alone is More Effective for Adult Participants With Advanced Non-Small","route":"/trials/nct05785767/"},{"id":"nct06769698","kind":"trial","name":"A Study to See if Giving Fianlimab and Cemiplimab Together is Better Than Cemiplimab Alone at Treating Recurrent or Metastatic Head and Neck Squamous ","route":"/trials/nct06769698/"},{"id":"nct06246916","kind":"trial","name":"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)","route":"/trials/nct06246916/"},{"id":"nct05800015","kind":"trial","name":"A Trial to Learn How the Combination of Fianlimab With Cemiplimab and Chemotherapy Works Compared With Cemiplimab and Chemotherapy for Treating Adult ","route":"/trials/nct05800015/"},{"id":"nct06190951","kind":"trial","name":"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","route":"/trials/nct06190951/"},{"id":"nct06161441","kind":"trial","name":"A Trial to Learn if the Combination of Fianlimab, Cemiplimab, and Chemotherapy is Safe and Works Better Than the Combination of Cemiplimab and Chemoth","route":"/trials/nct06161441/"},{"id":"nct05608291","kind":"trial","name":"A Trial to See if the Combination of Fianlimab With Cemiplimab Works Better Than Pembrolizumab for Preventing or Delaying Melanoma From Coming Back Af","route":"/trials/nct05608291/"},{"id":"nct07281768","kind":"trial","name":"Capecitabine/Oxaliplatin Chemotherapy and Cemiplimab With or Without Fianlimab or REGN7075 in Locally Advanced Rectal Cancer","route":"/trials/nct07281768/"},{"id":"nct06205836","kind":"trial","name":"Cemiplimab With or Without Fianlimab to Treat Older Patients With Localized or Locally Advanced MSI-H Colorectal Cancer","route":"/trials/nct06205836/"},{"id":"fianlimab-phase3-melanoma","kind":"trial","name":"Fianlimab + cemiplimab phase 3 (first-line melanoma)","route":"/trials/fianlimab-phase3-melanoma/"},{"id":"i-spy-2","kind":"trial","name":"I-SPY 2","route":"/trials/i-spy-2/"},{"id":"nct06787612","kind":"trial","name":"Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer","route":"/trials/nct06787612/"},{"id":"nct03916627","kind":"trial","name":"Neoadjuvant Cemiplimab for the Treatment of Resectable NSCLC, HCC, and HNSCC in Adult Patients","route":"/trials/nct03916627/"},{"id":"nct06865339","kind":"trial","name":"Thoracic Radiotherapy and Inhibition of PD-1 and LAG-3 for Locally Advanced Non-Small Cell Lung Cancer","route":"/trials/nct06865339/"}],"pairing":[{"id":"lag3-adjuvant-caution","kind":"pairing","name":"Caution: LAG-3 blockade outside active disease","route":"/pairings/lag3-adjuvant-caution/"}],"pathway":[{"id":"t-cell-exhaustion","kind":"pathway","name":"T-cell exhaustion","route":"/pathways/t-cell-exhaustion/"}]}}