European Commission Expands Keytruda-Padcev Use for Cisplatin-Eligible MIBC

The European Commission on Oct. 21 expanded EU approval of Merck’s Keytruda (pembrolizumab) and Astellas Pharma Inc.’s Padcev (enfortumab vedotin) for resectable muscle-invasive bladder cancer, adding patients who can receive cisplatin to the treatment population.

The regimen begins before surgery and continues after radical cystectomy, an operation to remove the bladder. The earlier EU indication covered adults unable to receive cisplatin-based chemotherapy. The expansion applies across the 27 EU member states, as well as Iceland, Liechtenstein and Norway; availability in each country depends in part on reimbursement procedures.

The Phase 3 KEYNOTE-B15 trial, also known as EV-304, randomized 808 cisplatin-eligible patients. Of those, 405 were assigned to the Keytruda-Padcev regimen before and after surgery, while 403 were assigned to gemcitabine-cisplatin before surgery.

At 24 months, estimated event-free survival was 79.4% for patients given the combination and 66.2% for those given chemotherapy. Estimated overall survival was 86.9% and 81.3%, respectively. Pathological complete response occurred in 55.8% of the combination group, compared with 32.5% of the chemotherapy group.

Grade 3 or higher adverse events of any cause occurred in 75.7% of patients in the combination group and 67.2% in the gemcitabine-cisplatin group.

The U.S. Food and Drug Administration approved the perioperative regimen on July 10 for adults with muscle-invasive bladder cancer who are candidates for cystectomy. That decision extended its prior use in patients unable to receive cisplatin.