Phase III CheckMate -214 study of Opdivo plus Yervoy (nivolumab + ipilimumab) in untreated advanced or metastatic renal cell carcinoma meets endpoint and advisory committee recommends halting study.- BMS.

Bristol-Myers Squibb announced that a Phase III CheckMate -214 study evaluating Opdivo plus Yervoy (nivolumab + ipilimumab) in patients with previously untreated advanced or metastatic renal cell carcinoma (RCC) met its co-primary endpoint, demonstrating superior overall survival (OS) compared to sunitinib in intermediate- and poor-risk patients. The combination also met a secondary endpoint of improved OS versus sunitinib in all randomized patients. Based on a planned interim analysis, an independent Data Monitoring Committee (DMC) has recommended that the trial be stopped early.

As previously reported, the combination of Opdivo plus Yervoy achieved an ORR of 41.6% versus 26.5% for sunitinib in poor- and intermediate-risk patients, a co-primary endpoint. Median duration of response was not reached for the combination and was 18.2 months for sunitinib. PFS in the intermediate- and poor-risk patients, a co-primary endpoint, improved 18% for those receiving the combination, [HR=0.82, (99.1% CI: 0.64 to 1.050); stratified two-sided (p=0.0331)], but did not reach the pre-defined statistical significance threshold of 0.009 compared to sunitinib. The median PFS for the combination group was 11.6 months (95% CI: 8.71 to 15.51) versus 8.4 months (95% CI: 7.0 to 10.8) for the sunitinib group.