Bristol Myers Squibb announced that the Phase 3 RELATIVITY-098 trial evaluating Opdualag (nivolumab and relatlimab-rmbw) for adjuvant treatment of completely resected stage III-IV melanoma did not meet its primary endpoint of recurrence-free survival. The safety profile of Opdualag remained consistent with previous studies. The company acknowledges that LAG-3 inhibition in the adjuvant setting did not demonstrate the same efficacy as in advanced melanoma.
This news impacts the melanoma treatment landscape. While Opdivo remains a standard of care for adjuvant melanoma, the trial results for Opdualag suggest the combination may be less effective in patients with completely resected tumors. This underscores the complexity of the immune response in different stages of melanoma and the need for tailored therapeutic strategies. The findings may influence treatment decisions for patients with resected stage III-IV melanoma, with physicians potentially favoring established therapies like Opdivo or Opdivo Qvantig.
The RELATIVITY-098 trial was a randomized, double-blind study comparing Opdualag to Opdivo monotherapy in patients with completely resected stage III-IV melanoma. The primary endpoint was recurrence-free survival, with secondary endpoints including overall survival, distant metastasis-free survival, and safety. The observed safety profile of Opdualag aligns with known profiles of nivolumab and relatlimab.
Despite this setback, Opdualag remains a standard of care for first-line treatment of unresectable or metastatic melanoma. Bristol Myers Squibb will continue to investigate Opdualag’s potential in other cancers, such as non-small cell lung cancer. This suggests a shift in focus toward earlier stages of disease where the combination might be more effective or toward different tumor types. The company will likely continue research to better understand the mechanisms underlying the observed difference in efficacy between the adjuvant and advanced melanoma settings.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
