Weekly Digest - August 2025

Weekly Digest - August 2025

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

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