Update on CheckMate -915 for Opdivo + Yervoy v. Opdivo alone in patients with resected high-risk melanoma and PD-L1 <1%.- BMS

Bristol-Myers Squibb Company announced results for one of the co-primary endpoints from CheckMate -915 a randomized Phase III study evaluating Opdivo (nivolumab) plus Yervoy (ipilimumab) versus Opdivo alone for the adjuvant treatment of patients who have had a complete surgical removal of stage IIIb/c/d or stage IV (no evidence of disease) melanoma .

A statistically significant benefit was not reached for the co-primary endpoint of recurrence-free survival (RFS) in patients whose tumors expressed PD-L1 <1%. the data monitoring committee recommended that the study continue unchanged. the study remains double-blinded and will continue to assess the other co-primary endpoint of rfs in the all-comer intent-to-treat population.>

About CheckMate -915 CheckMate -915 is a Phase III, randomized, placebo controlled, double-blind study evaluating Opdivo in combination with Yervoy versus Opdivo monotherapy, an approved standard of care, in patients who have had a complete surgical removal of stage IIIb/c/d or stage IV (no evidence of disease) melanoma. Patients enrolled in the trial had no prior anti-cancer treatment for melanoma, except surgery for the melanoma lesion(s) and/or adjuvant radiation therapy after neurosurgical resection for central nervous system lesions. The trial randomized 1,943 patients to receive either Opdivo 240 mg intravenously every two weeks and Yervoy 1 mg/kg every six weeks or Opdivo 480 mg every four weeks for one year.