Bristol-Myers Squibb (BMS ) has reported that the CheckMate -915 study of Opdivo (nivolumab) and Yervoy (ipilimumab) combination failed to meet one of the co-primary endpoints in patients with melanoma.
Opdivo is the company’s programmed death-1 (PD-1) immune checkpoint inhibitor that uses the body’s immune system against cancer.
Yervoy is a recombinant, human monoclonal antibody designed by the company to attach to and block the cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4), which negatively regulates T-cell activity.
The randomised, placebo-controlled, double-blind Phase III CheckMate -915 study compared Opdivo and Yervoy combination with Opdivo alone in patients who underwent a complete surgical removal of stage IIIb/c/d or stage IV melanoma.
It involved a total of 1,943 patients who did not receive previous anti-cancer therapy for melanoma, except surgery for lesion(s) and/or adjuvant radiation therapy after removal of central nervous system lesions.
Participants were treated with 240mg intravenous Opdivo every two weeks and 1mg/kg Yervoy every six weeks or 480mg Opdivo every four weeks for 12 months.
Data showed that the combination did not achieve a statistically significant benefit for the co-primary endpoint of recurrence-free survival (RFS) in patients with tumours expressing PD-L1 <1%.
A Data Monitoring Committee recommended that the trial can continue without any changes.
The study will remain double-blinded and will continue to evaluate the co-primary endpoint of RFS in the all-comer (intent-to-treat) patient population.
During the open-label, multi-centre, randomised study, the combination was compared to chemotherapy alone as first-line therapy.