Bristol Myers’ Phase III Opdualag trial misses goal

Bristol Myers Squibb (NYSE: BMY) today announced the Phase III RELATIVITY-098 trial evaluating Opdualag (nivolumab and relatlimab-rmbw) for the adjuvant treatment of patients with completely resected stage III-IV melanoma did not meet its primary endpoint of recurrence-free survival (RFS).

However, the US pharma major noted that the safety profile of Opdualag observed in this analysis was consistent with the known profiles of nivolumab and relatlimab.

“We are disappointed in the outcome of the RELATIVITY-098 trial and that LAG-3 inhibition in the adjuvant setting did not lead to the same improved efficacy outcomes seen in advanced melanoma,” said Dr Jeffrey Walch, vice president, Opdualag global program lead, Bristol Myers Squibb. “Patients whose tumors are completely resected before treatment may not have sufficient antitumor T cells in place for Opdualag to have its maximal effect. However, Opdualag remains a standard of care in the first-line treatment of unresectable or metastatic melanoma, and we continue to explore its potential across tumor types, including in non-small cell lung cancer,” he noted.