BMY - Monumental surprise. Interesting that BMY very explicitly described 5% cutoff as primary endpoint, on recent investor calls it's sounded like they were conducting a hierarchical analysis that would have started at higher cutoffs. Will be very interesting to see data at 10%, 25%, 50% cutoffs, but seems like a stretch to expect any regulatory path forward even if those data are good.
Still think BMY is well positioned in 1L NSCLC with combo trials, but this failure certainly casts a spectrer over their program.
Also, of note, it's the very first Phase 3 failure for a PD-1 inhibitor.