In advanced melanoma, adding the drug relatlimab to nivolumab kept the disease under control in more patients at 4 years of follow-up, and the percentage of patients alive was numerically higher, but the survival difference is not statistically conclusive.
Unresectable or metastatic melanoma, first line (ESMO: I, B); or after failure of anti-PD-1 monotherapy
| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Nivolumab + relatlimab (fixed-dose combination) | 480 mg nivolumab + 160 mg relatlimab | IV, 30-minute infusion | Day 1 every 4 weeks |
Per the FDA label; for adults and children aged 12 years and older weighing at least 40 kg.
On the page “Melanoma (skin cancer)” · Unresectable or metastatic melanoma: first-line immunotherapy
Doses follow the trial protocol, guideline or official drug label (source given in the notes of each regimen). Before prescribing, check blood counts, renal and hepatic function, drug interactions and the patient’s condition, and adjust the dose according to the drug label.
Fixed-dose combination of relatlimab 160 mg + nivolumab 480 mg in a single 60-minute IV infusion every 4 weeks, until disease progression, unacceptable toxicity or withdrawal. (The current FDA label recommends a 30-minute infusion.)
Nivolumab 480 mg as a 60-minute IV infusion every 4 weeks, until disease progression, unacceptable toxicity or withdrawal.
Source of the regimen details: Abstract of the paper, full text of the original report (NEJM 2022; PMC9844513) and the FDA label (OPDUALAG)
Doses are given for the information of specialists, as in this study’s protocol, and are not a prescription. Every drug must be prescribed by the treating physician for the individual patient.
Patients aged 12 or older with histologically confirmed unresectable stage III or IV melanoma, without prior treatment for advanced disease, with measurable disease (RECIST 1.1) and tissue evaluable for LAG-3 and PD-L1. Prior adjuvant/neoadjuvant treatment with a PD-1, CTLA-4, BRAF or MEK inhibitor was allowed if completed at least 6 months before recurrence. Uveal melanoma and active untreated brain or leptomeningeal metastases were excluded. Stratified by LAG-3 and PD-L1 expression, BRAF V600 mutation and metastasis stage/LDH.
Primary: progression-free survival by blinded independent central review; other outcomes included overall survival, objective response and melanoma-specific survival.
No new or unexpected safety signal was identified in this update. In the original report, grade 3 or 4 treatment-related adverse events occurred in 18.9% of patients on relatlimab + nivolumab and 9.7% of patients on nivolumab.
The ESMO 2025 guideline lists nivolumab + relatlimab as one of the first-line options (I, B).
The analyses are descriptive, and the overall survival benefit was not statistically significant in the primary analysis.
This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.
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