Bristol Myers Squibb (BMY)

[DewDiligence]

Opdivo monotherapy—>statsig OS/PFS as_addend_to_cisplatin_in first-line bladder cancer:

https://finance.yahoo.com/news/opdivo-nivolumab-combination-cisplatin-based-105900450.html

The trial in question is a 600-patient sub-study of CHECKMATE-901, which is now complete. (The other part of CHECKMATE-901, which compares Opdivo/Yervoy vs chemo, is ongoing.) The trial had no requirement for PD-L1 expression.

Today’s PR does not contain a hazard ratio or any other detailed results; those data will be presented at an unspecified medical conference.

Opdivo for bladder cancer is already FDA-approved in the adjuvant (#msg-165546303) and second-line (#msg-128386168) settings. Approval in the first-line (unresectable or metastatic) setting would give Opdivo across-the-board coverage for bladder cancer.