Bristol Myers Squibb (BMY)

[DewDiligence]

BMY presents OS data from successful CHECKPOINT-214 study in first-line RCC:

https://finance.yahoo.com/news/opdivo-plus-yervoy-combination-delivered-133500623.html

…an overall survival (OS) advantage was seen with the Opdivo plus Yervoy combination over sunitinib in both the PD-L1 expression level <1% [HR= 0.73, (CI: 95% 0.56 to 0.96)] and ≥1% subgroups [HR= 0.45 (CI: 95% 0.29 to 0.71)].

The median overall survival (OS) was not reached for the Opdivo plus Yervoy combination or sunitinib for those with PD-L1 levels < 1%, and for patients with PD-L1 expression levels ≥1%, the median OS was not reached for the combination and was 19.6 months for sunitinib.

CHECKPOINT-214 was stopped early for OS success in Sep 2017 (#msg-134437412), but the details were not disclosed until now.

CHECKPOINT-214 tested Opdivo+Yervoy vs Sutent and had three co-primary endpoints: ORR, PFS, and OS. In Aug 2017, BMY reported that the trial hit the ORR endpoint and missed on PFS (#msg-133869270).