BMS finds co-primary endpoint in CheckMate Opdivo-combination related study, misses statistical significance
August 16, 2017Bristol-Myers Squibb announced results from the CheckMate -214 trial on Tuesday, investigating Opdivo (nivolumab) in combination with Yervoy (ipilimumab) versus sunitinib in intermediate and poor-risk patients previously untreated advanced or metastatic renal cell carcinoma.
BMS said that 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), it did not reach statistical significance. The median PFS was 11.56 months for the Opdivo and Yervoy combination versus 8.38 months 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.
