{"entity":{"id":"relatlimab-nivolumab","kind":"drug","name":"Relatlimab + nivolumab","aka":[],"tldr":"Opdualag combines relatlimab, the first drug targeting the LAG-3 immune brake, with nivolumab for melanoma.","summary":"Opdualag is a fixed-dose combination of relatlimab, an antibody against the LAG-3 checkpoint, and nivolumab, an anti-PD-1 antibody, given as one infusion of nivolumab 480 mg with relatlimab 160 mg every 4 weeks. Because LAG-3 and PD-1 sit on the same exhausted T cells, releasing both brakes at once restores T-cell function more fully than PD-1 blockade alone. In RELATIVITY-047, in untreated advanced melanoma, progression-free survival was 10.1 versus 4.6 months compared with nivolumab alone, with less toxicity than ipilimumab-nivolumab. It was approved in 2022 in the US for unresectable or metastatic melanoma in patients aged 12 and over, the first LAG-3 therapy, and in the EU for PD-L1-negative melanoma. Fatigue, rash, thyroid dysfunction and adrenal insufficiency occur, and myocarditis is rare but monitored. Adjuvant and other tumour trials are ongoing.","status":"approved","asOf":"2026-09-04","wikipedia":"https://en.wikipedia.org/wiki/Nivolumab/relatlimab","links":[{"label":"FDA label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Relatlimab"}],"tags":[],"related":[],"cancers":["melanoma","advanced-melanoma"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":["lag3","pd1"],"drugs":[],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":["nct06246916","nct05625399","nct06101134","nct05970497"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Opdualag","modality":"Fixed-dose bispecific combination (anti-LAG-3 + anti-PD-1)","mechanism":"Anti-LAG-3 plus anti-PD-1 in one infusion.","approvals":[{"region":"US","year":2022,"indication":"Unresectable or metastatic melanoma, age ≥12"},{"region":"EU","year":2022,"indication":"Melanoma, PD-L1 <1% restriction"}],"mechanismSteps":["Relatlimab binds LAG-3 and nivolumab binds PD-1 on the same exhausted T cells","Two inhibitory checkpoints are released simultaneously","T cells regain proliferation and cytotoxic function","Tumour is infiltrated and killed; less toxicity than CTLA-4 combination"],"dosing":{"route":"IV infusion","schedule":"Nivolumab 480 mg + relatlimab 160 mg every 4 weeks (≥40 kg)","modifications":"As for nivolumab; hold for grade 2 immune-mediated events","monitoring":"Thyroid, LFTs, creatinine, glucose; adrenal function; myocarditis awareness","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"},"toxicity":[{"event":"Fatigue"},{"event":"Musculoskeletal pain"},{"event":"Rash"},{"event":"Pruritus"},{"event":"Diarrhoea"},{"event":"Hypothyroidism/thyroiditis"},{"event":"Adrenal insufficiency"},{"event":"Myocarditis (rare, monitor troponin)"}],"access":[{"country":"US","reimbursement":"Medicare Part B (physician-administered); commercial plans per formulary","assistance":"https://www.bmsaccesssupport.com","source":"https://www.cms.gov/medicare/payment/part-b-drugs/asp-pricing-files","asOf":"2026-09-06"},{"country":"UK","reimbursement":"NICE: recommended for untreated advanced melanoma, PD-L1 <1% (2024)","source":"https://www.nice.org.uk/guidance/published?ngt=Technology%20appraisal%20guidance","asOf":"2026-09-06"}],"regulatoryEvents":[{"date":"2022-03-18","type":"approval","region":"US","note":"Unresectable or metastatic melanoma, age ≥12 (RELATIVITY-047): first LAG-3 therapy","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"},{"date":"2022-09","type":"approval","region":"EU","note":"EMA approval, PD-L1 <1% melanoma","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"}]},"route":"/drugs/relatlimab-nivolumab/","neighbours":{"cancer":[{"id":"advanced-melanoma","kind":"cancer","name":"Advanced melanoma (unresectable stage III and stage IV)","route":"/cancers/advanced-melanoma/"},{"id":"braf-v600-melanoma","kind":"cancer","name":"BRAF V600-mutant melanoma","route":"/cancers/braf-v600-melanoma/"},{"id":"melanoma","kind":"cancer","name":"Melanoma","route":"/cancers/melanoma/"}],"technology":[{"id":"checkpoint-inhibitor","kind":"technology","name":"Immune checkpoint inhibitors","route":"/technologies/checkpoint-inhibitor/"}],"target":[{"id":"fgl1","kind":"target","name":"FGL1","route":"/targets/fgl1/"},{"id":"lag3","kind":"target","name":"LAG-3","route":"/targets/lag3/"},{"id":"pd1","kind":"target","name":"PD-1","route":"/targets/pd1/"}],"company":[{"id":"bms","kind":"company","name":"Bristol Myers Squibb","route":"/companies/bms/"}],"trial":[{"id":"nct05970497","kind":"trial","name":"A Study Assessing KB707 for the Treatment of Locally Advanced or Metastatic Solid Tumors","route":"/trials/nct05970497/"},{"id":"nct05625399","kind":"trial","name":"A Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination (FDC) in Previously Untreated Metastatic or Unresectable Melanoma","route":"/trials/nct05625399/"},{"id":"nct06101134","kind":"trial","name":"A Study to Evaluate Whether Participants With Melanoma Prefer Subcutaneous vs Intravenous Administration of Nivolumab and Nivolumab + Relatlimab Fixed","route":"/trials/nct06101134/"},{"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":"relativity-047","kind":"trial","name":"RELATIVITY-047","route":"/trials/relativity-047/"},{"id":"relativity-098","kind":"trial","name":"RELATIVITY-098","route":"/trials/relativity-098/"},{"id":"nct06264180","kind":"trial","name":"VO and Nivolumab vs Physician's Choice in Advanced Melanoma That Progressed on Anti-PD-1 & Anti-CTLA-4 Drugs [IGNYTE-3]","route":"/trials/nct06264180/"}],"pairing":[{"id":"lag3-adjuvant-caution","kind":"pairing","name":"Caution: LAG-3 blockade outside active disease","route":"/pairings/lag3-adjuvant-caution/"}],"pathway":[{"id":"pd1-checkpoint","kind":"pathway","name":"PD-1 / PD-L1 immune checkpoint & T-cell activation","route":"/pathways/pd1-checkpoint/"},{"id":"t-cell-exhaustion","kind":"pathway","name":"T-cell exhaustion","route":"/pathways/t-cell-exhaustion/"}],"roadmap":[{"id":"immunotherapy-roadmap","kind":"roadmap","name":"Immunotherapy roadmap: Coley's toxins → checkpoint inhibitors → engineered immunity","route":"/roadmaps/immunotherapy-roadmap/"}],"person":[{"id":"hussein-tawbi","kind":"person","name":"Hussein A. Tawbi","route":"/people/hussein-tawbi/"}],"paper":[{"id":"paper-checkmate-067-10-year-nejm-2025","kind":"paper","name":"CheckMate 067 at ten years: nivolumab plus ipilimumab produces long-term survival in half of patients with advanced melanoma","route":"/key-papers/paper-checkmate-067-10-year-nejm-2025/"},{"id":"paper-relativity-047-nejm-2022","kind":"paper","name":"RELATIVITY-047: relatlimab plus nivolumab, the first LAG-3 checkpoint combination, in untreated advanced melanoma","route":"/key-papers/paper-relativity-047-nejm-2022/"}],"institution":[{"id":"pascale-naples","kind":"institution","name":"Istituto Nazionale Tumori IRCCS Fondazione G. Pascale","route":"/institutions/pascale-naples/"},{"id":"upmc-hillman","kind":"institution","name":"UPMC Hillman Cancer Center","route":"/institutions/upmc-hillman/"}]}}