Astellas Reports Positive Phase 3 EV-304 Results For PADCEV Combo In Muscle-Invasive Bladder Cancer

Astellas Pharma

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(RTTNews) - Astellas Pharma Inc. and Pfizer Inc. announced positive topline results from the Phase 3 EV-304 clinical trial (KEYNOTE-B15), evaluating PADCEV (enfortumab vedotin), a Nectin-4 directed antibody-drug conjugate, in combination with Keytruda® (pembrolizumab), a PD-1 inhibitor. The study assessed the combination as both neoadjuvant and adjuvant treatment—before and after surgery—compared to standard cisplatin-based chemotherapy in patients with muscle-invasive bladder cancer (MIBC).

The trial successfully met its primary endpoint, demonstrating clinically meaningful and statistically significant improvements in event-free survival (EFS). It also achieved a key secondary endpoint, showing significant improvement in overall survival (OS). Importantly, PADCEV plus Keytruda is the first and only platinum-free regimen to improve both event-free and overall survival in cisplatin-eligible patients with MIBC when used around surgery.

In addition, the study met another secondary endpoint, with a clinically meaningful and statistically significant improvement in pathologic complete response (pCR) rates for patients receiving PADCEV plus Keytruda compared to those treated with standard neoadjuvant chemotherapy. The safety profile of the combination was consistent with the known characteristics of the regimen.

The results, combined with the unprecedented findings from the EV-303 trial, highlight the potential of PADCEV plus Keytruda to establish a new platinum-free standard of care for earlier-stage bladder cancer. Findings from the EV-304 trial will be presented at an upcoming medical meeting and discussed with global health authorities to support potential regulatory filings.

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