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# BMS Reports Disappointing Data in Melanoma Trial
- URL: https://www.fdaweb.com/bms-reports-disappointing-data-in-melanoma-trial/
- Published: 2025-02-14T12:00:00.000Z
- Updated: 2026-09-14T14:53:13.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158664

Bristol Myers Squibb says its Phase 3 RELATIVITY-098 trial evaluating Opdualag (nivolumab and relatlimab-rmbw) for treating patients with completely resected stage III-IV melanoma did not meet its primary endpoint of recurrence-free survival. It notes that the therapy’s safety profile observed in the trial was consistent with previously known profiles. Opdualag was originally approved in 2022 for treating adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma.

Opdualag is described as is a first-in-class, fixed-dose, dual immunotherapy combination of the programmed death-1 (PD-1) inhibitor nivolumab and the lymphocyte activation gene 3 (LAG-3) blocking antibody relatlimab. “Preclinical studies indicate that inhibition of LAG-3 may promote an anti-tumor response. Targeting both LAG-3 and PD-1 in combination may be a key strategy to help restore T cell activity, improving anti-tumor response in certain cancers that is greater than the effects of PD-1 monotherapy,” the company says. The therapy is being evaluated in clinical trials in combination with other agents in a variety of tumor types.