Bristol Myers Squibb’s Opdualag Fails Phase 3 Trial in Adjuvant Melanoma Treatment

Opdualag did not meet its primary endpoint of recurrence-free survival in the Phase 3 RELATIVITY-098 trial for adjuvant treatment of completely resected stage III-IV melanoma8.

The trial compared Opdualag (nivolumab and relatlimab-rmbw) to nivolumab monotherapy in patients with completely resected melanoma8.

Opdualag is a first-in-class, fixed-dose combination of the PD-1 inhibitor nivolumab and the LAG-3 blocking antibody relatlimab18.

The failure in the adjuvant setting could significantly reduce Opdualag's long-term revenue prospects, potentially missing out on a market opportunity nearly twice as large as its current approved indication2.

Opdualag remains approved and is considered a standard of care for first-line treatment of unresectable or metastatic melanoma8.

The safety profile of Opdualag observed in this trial was consistent with the known profiles of nivolumab and relatlimab8.

Bristol Myers Squibb continues to explore Opdualag's potential across other tumor types, including non-small cell lung cancer8.

This setback follows a previous failure of Opdualag in a Phase 3 trial for metastatic colorectal cancer in December 20235.

Sources:

1. https://news.bms.com/news/details/2022/U.S.-Food-and-Drug-Administration-Approves-First-LAG-3-Blocking-Antibody-Combination-Opdualag-nivolumab-and-relatlimab-rmbw-as-Treatment-for-Patients-with-Unresectable-or-Metastatic-Melanoma/default.aspx

2. https://www.biospace.com/drug-development/bms-phase-iii-opdualag-melanoma-fail-could-limit-market-opportunity-analysts

5. https://www.fiercepharma.com/pharma/bristol-myers-squibbs-opdualag-hits-wall-colorectal-cancer-scrapped-trial

8. https://news.bms.com/news/corporate-financial/2025/Bristol-Myers-Squibb-Provides-Update-on-Phase-3-RELATIVITY-098-Trial/default.aspx