Pfizer and Astellas Pharma have received approval from the US Food and Drug Administration (FDA) for PADCEV (enfortumab vedotin-ejfv) in combination with Keytruda (pembrolizumab) or Keytruda QLEX as neoadjuvant and adjuvant treatment for adults with muscle-invasive bladder cancer (MIBC), regardless of their eligibility for cisplatin-based chemotherapy.

The approval makes the combination the first platinum-free perioperative treatment regimen approved for adults with MIBC across all cisplatin eligibility groups.

The decision is based on results from the Phase 3 EV-304 (KEYNOTE-B15) clinical trial, which evaluated the combination before and after surgery against standard neoadjuvant chemotherapy. The expanded indication follows the FDA’s November 2025 approval of the regimen for patients who were ineligible for cisplatin.

In the EV-304 trial, patients received either PADCEV plus pembrolizumab before and after surgery or standard neoadjuvant treatment with gemcitabine and cisplatin before surgery. The combination therapy included nine planned cycles of PADCEV and 17 planned cycles of pembrolizumab, administered across the neoadjuvant and adjuvant settings.

The study showed that the PADCEV and pembrolizumab combination reduced the risk of tumour recurrence, disease progression or death by 47% compared with standard chemotherapy. At two years, an estimated 79.4% of patients receiving the combination remained event-free, compared with 66.2% of those treated with chemotherapy.

The regimen also reduced the risk of death by 35% and achieved a pathological complete response rate of 55.8%, compared with 32.5% in the chemotherapy group.

The safety profile was consistent with previous studies of the combination, with no new safety concerns identified. Grade 3 or higher adverse events occurred in 75.7% of patients receiving PADCEV plus pembrolizumab, compared with 67.2% of those receiving standard chemotherapy.

The ongoing Phase 3 EV-304 trial is evaluating the combination as perioperative treatment in patients with muscle-invasive bladder cancer who are eligible for cisplatin-based chemotherapy. The primary endpoint is event-free survival, while key secondary endpoints include overall survival and pathological complete response.

 

Source: astellas.com

Report Abuse