=Bristol-Myers (BMY): kidney cancer drug fails late-stage trial

• Bristol-Myers Squibb Co said on Tuesday its combination drug to treat previously untreated patients with advanced or metastatic renal cell carcinoma, a type of kidney cancer, failed to meet one of the main goals of a late-stage trial.
• The combination of Bristol-Myers' two top drugs, Opdivo and Yervoy, was not statistically significant in improving progression-free survival in patients, when compared with standard-of-care drug sunitinib.
• The treatment, however, met another main goal of the study.

Bristol-Myers announces topline results from CheckMate -214, a Phase 3 study of Opdivo + Yervoy in with advanced or metastatic Renal Cell Carcinoma; co-primary endpoint of objective response rate was met for the combo but Progression-Free Survival did not reach statistical significance(57.87 +0.25)

Co announced topline results from the CheckMate -214 trial investigating Opdivo (nivolumab) in combination with Yervoy (ipilimumab) versus sunitinib in intermediate and poor-risk patients previously untreated advanced or metastatic renal cell carcinoma. The combination met the co-primary endpoint of objective response rate (ORR) and achieved a 41.6% ORR versus 26.5% for sunitinib. Median duration of response was not reached for the combination of Opdivo and Yervoy and was 18.17 months for sunitinib. While there was an improvement in progression-free survival (PFS) (HR=0.82, [95% CI 0.64 -- 1.05]; stratified 2-sided p=0.03), it did not reach statistical significance. The median PFS was 11.56 months (95% CI 8.71 -- 15.51) for the Opdivo and Yervoy combination versus 8.38 months (95% CI 7.03-10.81) for sunitinib, The study will continue as planned to allow the third co-primary endpoint of overall survival to mature. The tolerability profile observed in CheckMate-214 was consistent with that observed in previously reported studies of this dosing schedule.

"We are encouraged by the totality of the CheckMate-214 data. The overall response rate and durability of response favored the combination of Opdivo and Yervoy, and the trend for PFS supports the potential of the combination in intermediate and poor-risk advanced renal cell carcinoma, the most common type of kidney cancer. This is an important study in first-line renal cancer as these patients need new options,"