PADCEV plus Keytruda reduces bladder cancer recurrence risk by 47%

Pfizer Inc. (NYSE: PFE) and Astellas Pharma Inc. (TSE: 4503) announced results from the Phase 3 EV-304 clinical trial showing that the combination of PADCEV (enfortumab vedotin) and Keytruda (pembrolizumab) reduced the risk of tumor recurrence, progression or death by 47% in patients with muscle-invasive bladder cancer eligible for cisplatin-based chemotherapy.

The perioperative treatment, administered before and after surgery, demonstrated a hazard ratio of 0.53 compared to standard neoadjuvant chemotherapy with gemcitabine and cisplatin. An estimated 79.4% of patients receiving the combination were event-free at two years, compared to 66.2% treated with standard chemotherapy.

The trial also showed a 35% reduced risk of death for patients treated with the combination versus neoadjuvant chemotherapy, with a hazard ratio of 0.65. The pathological complete response rate was 55.8% for the combination compared to 32.5% for standard chemotherapy, indicating that more than half of patients treated with the combination had no detectable disease at surgery.

Grade 3 or higher adverse events occurred in 75.7% of patients treated with the combination compared to 67.2% of patients receiving neoadjuvant chemotherapy. The safety profile was consistent with prior experience with the combination.

The companies plan to discuss these results with global health authorities for potential regulatory filings. PADCEV plus pembrolizumab received FDA approval in November 2025 for perioperative treatment in cisplatin-ineligible patients with muscle-invasive bladder cancer based on results from the EV-303 trial.

The data were presented at the American Society of Clinical Oncology Genitourinary Cancers Symposium in San Francisco. Muscle-invasive bladder cancer represents approximately 30% of all bladder cancer cases, with about half of patients experiencing disease recurrence even after surgery.

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