BMS's Opdivo/Yervoy combo improves OS in first-line RCC

Bristol-Myers Squibb Co. (NYSE:BMY) reported additional data from the Phase III CheckMate -214 trial in about 1,070 previously untreated patients with advanced or metastatic renal cell carcinoma (RCC) showing that Opdivo nivolumab (BMS-936558, MDX-1106, ONO-4538) plus Yervoy ipilimumab as first-line treatment met the co-primary endpoint of improving overall survival (OS) vs. Sutent sunitinib in intermediate- and poor-risk patients. Opdivo plus Yervoy also met the secondary endpoint of improving OS vs. Sutent among all randomized patients in the trial. Based on the data, an IDMC recommended stopping the trial early.

The trial evaluated 3 co-primary endpoints that compared Opdivo plus Yervoy to Sutent in intermediate- and poor-risk patients, which comprised about 75% of patients in the trial. Last month, BMS reported that Opdivo plus Yervoy met the co-primary endpoint of improving objective response rate (ORR) (41.6% vs. 26.5%), but missed the co-primary endpoint of improving progression-free survival (PFS) (11.56 vs. 8.38 months, p=0.0331) vs. Sutent. The pre-defined threshold for significance on the PFS endpoint was a p-value of 0.009. The open-label, international trial's secondary endpoint is safety (see BioCentury, Aug. 17)...