Supplemental NDA submitted in Japan for PADCEV + Keytruda in Cisplatin-Eligible Patients with MIBC
The sNDA is based on results from the Phase 3 EV-304 clinical trial (also known as KEYNOTE-B15). In EV-304, neoadjuvant and adjuvant enfortumab vedotin plus pembrolizumab was compared with standard-of-care neoadjuvant gemcitabine and cisplatin chemotherapy in MIBC patients eligible for cisplatin-containing chemotherapy. In the Event-Free Survival (EFS) analysis, enfortumab vedotin plus pembrolizumab demonstrated a 47% reduction in the risk of tumor recurrence, progression, or death.1 In the Overall Survival (OS) analysis, enfortumab vedotin plus pembrolizumab demonstrated a 35% reduction in the risk of death. Results of EV-304 were presented at the 2026 American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU).
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