Antibody-Drug Conjugate PADCEV TM (Enfortumab Vedotin) Shows Favorable Results in Phase III EV-304 Trial for Cisplatin-Eligible Muscle-Invasive Bladder Cancer

Product and Service Overview

PADCEV TM (Enfortumab Vedotin [recombinant]) is a first-in-class antibody-drug conjugate (ADC) targeting Nectin-4, co-developed with Pfizer Inc. The combination therapy with Pembrolizumab (recombinant) is being evaluated in the Phase III EV-304 trial for patients with cisplatin-eligible muscle-invasive bladder cancer (MIBC). The trial assessed this regimen as neoadjuvant and adjuvant therapy, demonstrating significant improvements in event-free survival (EFS), overall survival (OS), and pathological complete response (pCR) rate compared to the conventional neoadjuvant chemotherapy (gemcitabine and cisplatin). Safety profile was consistent with existing treatments. The launch timing is unknown but is factored into the full-year earnings guidance for the fiscal year ending March 2026.

Market Impact and Outlook

Bladder cancer ranks as the ninth most common cancer globally, with MIBC accounting for approximately 30% of bladder cancer cases. The current standard treatment involves cisplatin-based neoadjuvant chemotherapy followed by surgery, but recurrence rates remain high. The combination therapy of PADCEV and Pembrolizumab provides important evidence as a novel non-chemotherapy adjunctive therapy and regulatory approval submissions are under consideration. The U.S. FDA has already approved PADCEV for cisplatin-ineligible MIBC, and Astellas Pharma plans to contribute to addressing unmet medical needs in bladder cancer treatment through this combination therapy.