BMS Phase III’s combination trial for RCC meets one co-primary endpoint
Bristol-Myers Squibb (BMS) has reported top-line results from the Phase III CheckMate -214 clinical trial of Opdivo (nivolumab) and Yervoy (ipilimumab) combination to treat advanced or metastatic renal cell carcinoma (RCC).
Opdivo is an immune checkpoint inhibitor of programmed death-1 (PD-1), while Yervoy is designed to inhibit cytotoxic T-lymphocyte antigen-4 (CTLA-4).
The trial has met the co-primary endpoint of objective response rate (ORR), while another co-primary endpoint of progression-free survival (PFS) did not achieve statistical significance but indicated improvement.
Bristol-Myers Squibb Melanoma and Genitourinary Cancers development lead Vicki Goodman said: “This is an important study in first-line renal cancer as these patients need new options.
“Opdivo is now well established as standard-of-care in the treatment of second-line renal cell carcinoma.
“The company plans to share the important first-line data with regulatory authorities and we look forward to reporting overall survival when these data mature.”
The randomised, open-label Phase III trial compared 3mg of Opdivo and 1mg of Yervoy combination with 50mg of sunitinib in poor-risk patients who were previously untreated for RCC.
While the combination was administered every three weeks for four doses followed by every two weeks, sunitinib was given once daily for four weeks with two weeks off before continuation.
The trial’s secondary endpoint was safety, and the tolerability profile of the combination was found to be consistent with that reported in prior trials with the same dosing schedule.
BMS plans to continue the trial to allow the third co-primary endpoint of overall survival to mature.