The FDA has approved Pfizer and Astellas’ Padcev (enfortumab vedotin-ejfv) plus Merck’s Keytruda (pembrolizumab) as a perioperative treatment for adults with muscle-invasive bladder cancer who are ineligible for cisplatin-based chemotherapy.
The approval comes following a phase 3 EV-303 trial that showed a 60% reduction in the risk of disease recurrence, progression or death, and a 50% reduction in the risk of death compared to surgery alone. Event-free survival was 74.7% with the combination therapy, versus 39.4% with surgery alone, according to the Nov. 21 press release from Pfizer. Two-year survival was 79.7% versus 63.1%, respectively.
Padcev targets nectin-4, a protein highly expressed in bladder cancer, and is already approved in combination with pembrolizumab for advanced urothelial cancer.
Adverse events of grade 3 or higher occurred in 71.3% of patients in the combination arm and 45.9% in the surgery-alone arm. The safety profile of the combination therapy was consistent with previous reports, according to the release.
