Bristol Myers Squibb (BMY)

[DewDiligence]

Opdivo monotherapy—>statsig-superior DFS—against placebo—in adjuvant UC:

https://www.businesswire.com/news/home/20200924005649/en

CheckMate -274 is a Phase 3 randomized, double-blind, multi-center study evaluating Opdivo compared to placebo in participants with muscle-invasive urothelial cancer at a high risk of recurrence after radical surgery. (Depending on patient characteristics, enrolled patients may or may not have received neoadjuvant chemotherapy prior to resection.)

A total of 709 patients were randomized 1:1 to receive Opdivo or placebo for up to one year. The primary endpoints of the trial are DFS in all randomized patients (i.e. the intention-to-treat population) and in the subset of patients whose tumors express PD-L1 >=1%.

DFS (the primary endpoint) was statig in both the full ITT population and the PD-L1>=1% subgroup, but the HRs have not yet been disclosed.