Astellas, Pfizer trial shows significant survival gains in bladder cancer

Astellas Pharma Inc. and Pfizer Inc. announced positive topline results from the Phase 3 EV-304 clinical trial for PADCEV (enfortumab vedotin) in combination with Keytruda (pembrolizumab). The trial, evaluating this combination as neoadjuvant and adjuvant treatment for cisplatin-eligible muscle-invasive bladder cancer (MIBC) patients, met its primary endpoint with statistically significant improvements in event-free survival (EFS) and overall survival (OS). The combination also achieved a statistically significant improvement in pathologic complete response (pCR) rate.

These results highlight the potential for the PADCEV plus Keytruda combination to become a new platinum-free standard of care for MIBC, offering significant survival gains across both cisplatin-eligible and cisplatin-ineligible patients. The safety profile observed in the EV-304 trial was consistent with the known profile of the treatment regimen. Regulatory filings and presentation at an upcoming medical meeting are planned.

PADCEV plus pembrolizumab has already received U.S. FDA approval as neoadjuvant and adjuvant treatment for cisplatin-ineligible MIBC patients, based on results from the Phase 3 EV-303 clinical trial. This further strengthens Astellas's full-year (March 2026) consolidated earnings forecast.