Padcev and Keytruda prevail again in early bladder cancer

Not long after getting FDA approval in perioperative muscle-invasive bladder cancer ineligible for chemo, a Padcev-Keytruda combo has succeeded in the perioperative chemo-eligible setting. Pfizer, Astellas and Merck & Co have just toplined as positive the Keynote-B15/EV-304 trial, testing the doublet given before and after surgery, versus chemo followed by surgery. The partners said the trial had shown a “statistically significant and clinically meaningful” benefit on the primary endpoint of event-free survival, as well as on secondary endpoints of overall survival and pathologic complete response rate. Full results are being reserved for an upcoming medical meeting; ASCO-GU, taking place in February in San Francisco, could be a contender. The companies will also discuss the data with regulators. If past trends are anything to go by, the doublet could get a quick decision: the US chemo-ineligible perioperative nod, based on Keynote-905/EV-303, came in November, just a month after the FDA accepted a filing. Separately, Merck is also testing Keytruda in another perioperative MIBC trial, Keynote-866, which pits a chemo combo against neoadjuvant chemo. However, that appears to have been delayed, with primary completion first shifting from February to September 2025, and more recently to January 2026.

Padcev + Keytruda in bladder cancer

Notes: EFS=event-free survival; OS=overall survival; pCR=pathologic complete response. Source: OncologyPipeline.