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Opdualag combines relatlimab, the first drug targeting the LAG-3 immune brake, with nivolumab for melanoma.
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.
Backbone ribbon from PDB 7UM3. RCSB PDB 7UM3. The ribbon widens where the chain is folded into a regular pattern and narrows where it is a loose loop.
1.Relatlimab binds LAG-3 and nivolumab binds PD-1 on the same exhausted T cells
Background: ADC sequencing, Antigen escape (antigen loss, lineage switch), BCG-unresponsive, Castration-resistant prostate cancer (CRPC), Circulating tumour DNA (ctDNA). Also on OnCo: Resistance: how tumours escape each drug class · Lines of therapy.
Source: www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications. Doses are for orientation; the current label governs.
Given by infusion or injection in a clinic or hospital outpatient department, so it is a Part B drug: Medicare pays 80% after the Part B deductible and the patient owes 20% coinsurance, uncapped in Original Medicare unless a Medigap policy applies.
Covered under the medical benefit with prior authorisation confirming diagnosis, biomarker status and line of therapy; site-of-care policies may steer infusions away from hospital outpatient departments.
20% Part B coinsurance on a high-cost infusion adds up quickly: Medigap Plan G or N, Medicare Advantage maximum out-of-pocket, Medicaid dual eligibility, or a charity fund are the usual buffers.
Sources: Medicare.gov: Chemotherapy · Medicare.gov: Prescription drugs (outpatient, Part B). Not medical or financial advice; verify with your plan.
Sources: NICE TA950 · SMC advice: nivolumab-relatlimab. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
Compare all products across the US, EU, UK, Japan, China and Australia →
Unresectable or metastatic melanoma, age ≥12 (RELATIVITY-047): first LAG-3 therapy source
EMA approval, PD-L1 <1% melanoma source
| Region | Year | Indication |
|---|---|---|
| US | 2022 | Unresectable or metastatic melanoma, age ≥12 |
| EU | 2022 | Melanoma, PD-L1 <1% restriction |
| Adverse event |
|---|
| Fatigue |
| Musculoskeletal pain |
| Rash |
| Pruritus |
| Diarrhoea |
| Hypothyroidism/thyroiditis |
| Adrenal insufficiency |
| Myocarditis (rare, monitor troponin) |
Events listed without rates were not read from a primary source; see the label. Blank cells mean the figure was not sourced, not that it is zero.
| Country | Reimbursement | List price | Assistance |
|---|---|---|---|
| United States | Medicare Part B (physician-administered); commercial plans per formulary | not disclosed | bmsaccesssupport.com |
| United Kingdom | NICE: recommended for untreated advanced melanoma, PD-L1 <1% (2024) | not disclosed | - |
List prices are manufacturer or Medicare figures where publicly disclosed; net prices after rebates are usually lower. Reimbursement changes; check the payer.
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For patients with advanced melanoma, immunotherapy offers a realistic chance of long-term survival and probably cure, and the ten-year data show that patients who are alive and progression-free at three years rarely die of melanoma afterwards. Nivolumab plus ipilimumab gives the best long-term results but at a high price in serious side effects; nivolumab alone or nivolumab plus relatlimab are alternatives for patients at lower risk or with autoimmune concerns. The trial is also a caution about surrogate endpoints: the survival plateau took years to become visible.
Patients with newly diagnosed advanced melanoma have a dual-checkpoint option that improves on nivolumab alone with only a modest increase in serious side effects, making it attractive for those unable to tolerate or unwilling to risk the toxicity of ipilimumab. It did not prove superior survival, and it has not been compared with nivolumab plus ipilimumab, which remains preferred for patients with brain metastases or other high-risk features. LAG-3 is now an established target under study in many other cancers.
Query for this drug: (TITLE:"Relatlimab + nivolumab" OR ABSTRACT:"Relatlimab + nivolumab" OR TITLE:"Opdualag" OR ABSTRACT:"Opdualag") 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 Relatlimab + nivolumab, not a curated reading list.
Shares Caution: LAG-3 blockade outside active disease, RELATIVITY-047, LAG-3, Advanced melanoma (unresectable stage III and stage IV).
Shares RELATIVITY-047, Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, RELATIVITY-047: relatlimab plus nivolumab, the first LAG-3 checkpoint combination, in untreated advanced melanoma, CheckMate 067 at ten years: nivolumab plus ipilimumab produces long-term survival in half of patients with advanced melanoma.
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 FGL1, LAG-3, Advanced melanoma (unresectable stage III and stage IV), Melanoma.
Shares Hussein A. Tawbi, BRAF V600-mutant melanoma, Advanced melanoma (unresectable stage III and stage IV), Bristol Myers Squibb.
Shares VO and Nivolumab vs Physician's Choice in Advanced Melanoma That Progressed on Anti-PD-1 & Anti-CTLA-4 Drugs [IGNYTE-3], Immunotherapy roadmap: Coley's toxins → checkpoint inhibitors → engineered immunity, Advanced melanoma (unresectable stage III and stage IV), Bristol Myers Squibb.
Shares Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, BRAF V600-mutant melanoma, PD-1, Melanoma.
Shares CheckMate 067 at ten years: nivolumab plus ipilimumab produces long-term survival in half of patients with advanced melanoma, Advanced melanoma (unresectable stage III and stage IV), PD-1, Melanoma.