Pfizer Inc. and Astellas Pharma Inc. have announced positive topline results from the Phase 3 EV-303 clinical trial, also known as KEYNOTE-905. The trial assessed the efficacy of PADCEV™ (enfortumab vedotin), a Nectin-4 directed antibody-drug conjugate, in combination with KEYTRUDA™ (pembrolizumab), a PD-1 inhibitor, as both neoadjuvant and adjuvant treatment compared to surgery alone in patients with muscle-invasive bladder cancer (MIBC) who are ineligible for or declined cisplatin-based chemotherapy. The study demonstrated a clinically meaningful and statistically significant improvement in event-free survival (EFS) and overall survival $(OS)$, with an additional secondary endpoint of pathologic complete response (pCR) rate being met. Details of the findings will be submitted for presentation at an upcoming medical congress and discussed with global health authorities for potential regulatory filings.
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