12 August 2025: PADCEV™ Plus KEYTRUDA™ Significantly Improves Survival for Certain Patients with Bladder Cancer When Given Before and After Surgery
PADCEV plus KEYTRUDA is the first regimen to significantly improve survival both before and after surgery in cisplatin-ineligible patients with muscle-invasive bladder cancer (MIBC), compared to surgery alone
The Phase 3 EV-303 (KEYNOTE-905) trial showed statistically significant improvements in event-free survival (EFS) and overall survival (OS), with the combination therapy meeting its primary and key secondary endpoints
A secondary endpoint, pathologic complete response (pCR) rate, was also achieved with the PADCEV plus KEYTRUDA combination
These results may lead to regulatory filings, as discussions with global health authorities are planned
The safety profile of the combination therapy was consistent with known effects of PADCEV and KEYTRUDA, and trial evaluations are ongoing as data matures