BMS announces update on CheckMate -915 evaluating Opdivo + Yervoy versus Opdivo in resected high-risk melanoma patients.

Bristol Myers Squibb announced results for the co-primary endpoint for CheckMate -915, a randomized Phase III study evaluating Opdivo (nivolumab) plus Yervoy (ipilimumab) versus Opdivo for patients who have had a complete surgical removal of stage IIIb/c/d or stage IV melanoma . The addition of Yervoy to Opdivo in this trial did not result in a statistically significant improvement in recurrence-free survival (RFS) in the all-comer (intent-to-treat) population. CheckMate -915 reinforced the established benefit of Opdivo monotherapy as a standard of care in the adjuvant setting. The safety profiles for Opdivo monotherapy and the combination of Opdivo plus Yervoy were consistent with previously reported studies at this dose and schedule (Opdivo 240 mg intravenously every two weeks plus Yervoy 1 mg/kg every six weeks or Opdivo 480 mg every four weeks for up to one year), with no new safety signals observed.