Bristol-Myers Announces Results From The Phase 3 CheckMate

(RTTNews) - Bristol-Myers Squibb Co. (BMY) announced results from the Phase 3 CheckMate -214 trial evaluating Opdivo or nivolumab plus Yervoy or ipilimumab versus sunitinib in patients with previously untreated advanced or metastatic renal cell carcinoma or RCC, including data on key subgroups.

With a minimum follow-up of 17.5 months, Opdivo in combination with Yervoy reduced the risk of death 37% [HR 0.63; 99.8% CI: 0.44 to 0.89; P < 0.0001] compared with sunitinib, the current standard of care, in an interim analysis of overall survival (OS) in intermediate- and poor-risk patients, the co-primary endpoint.

The median OS had not yet been reached for the combination and was 26 months for sunitinib (95% CI: 22.1 to NA). Results from CheckMate -214 will be presented today during Presidential Symposium II at the European Society for Medical Oncology (ESMO) 2017 Congress in Madrid, Spain, from 5:55-6:10 PM CEST in the Madrid Auditorium.

The Opdivo plus Yervoy combination also improved OS in all randomized patients, a secondary endpoint. In this population, the combination reduced the risk of death 32% [HR 0.68; 99.8% CI: 0.49 to 0.95; P=0.0003] compared with sunitinib. The median OS had not yet been reached for the combination and was 32.9 months for sunitinib (95% CI: NA to NA).

Results for objective response rate or ORR and progression-free survival or PFS in intermediate- and poor-risk patients, the two other co-primary endpoints, were previously reported. The safety of the combination was consistent with that observed in previously reported studies of these medicines in patients with RCC.