Bristol Myers CMO Addresses LAG-3 Concerns After Opdualag’s Adjuvant Melanoma Setback at ASCO 2025

At ASCO 2025, Bristol Myers Squibb (BMS) disclosed full results from the negative RELATIVITY-098 trial, which tested Opdualag (a fixed-dose combination of Opdivo and the LAG-3 antibody relatlimab) as adjuvant therapy in resected stage III and IV melanoma1.

Opdualag failed to demonstrate a difference from Opdivo monotherapy in preventing disease recurrence or death; both arms showed about 39% recurrence or mortality rate at a median follow-up of 23.4 months1.

Two-year recurrence-free survival rates were statistically similar:
62% (Opdualag) versus 63.6% (Opdivo)1.

The study found higher rates of grade 3 or 4 treatment-related adverse events with Opdualag (19%) compared to Opdivo alone (8%)1.

Bristol Myers' CMO publicly dismissed concerns that the setback in melanoma would impact prospects for LAG-3–based regimens in lung cancer and other indications, referencing different disease biology and therapeutic contexts1.

Opdualag remains approved for unresectable or metastatic melanoma in patients aged 12 and above, but attempts to expand its label—like this adjuvant melanoma study—have been unsuccessful5.

BMS leadership cited the unique immune landscape of patients with completely resected tumors as a reason for the lack of efficacy in the adjuvant setting, contrasting it with advanced melanoma where Opdualag shows benefit5.

Sources:

1. https://www.fiercepharma.com/pharma/bristol-myers-cmo-brushes-lag-3-concern-lung-cancer-after-opdualags-adjuvant-melanoma-flop

5. https://www.fiercepharma.com/pharma/bristol-myers-squibb-comes-short-bid-expand-opdualag-melanoma