Overview
- Adults with muscle-invasive bladder cancer who cannot receive cisplatin can now receive Padcev with either Keytruda or the subcutaneous Keytruda Qlex formulation.
- Treatment is given before surgery and continued after cystectomy as a perioperative regimen.
- In EV-303 (KEYNOTE-905), the combination cut the risk of event-free survival events by 60% and improved overall survival by 50%, with two-year survival of 79.7% versus 63.1% and pathologic complete response rates of 57.1% versus 8.6%.
- Investigators reported no new safety signals, while labeling highlights immune-mediated adverse reactions, infusion-related reactions, potential fetal harm, and a Keytruda Qlex contraindication in patients hypersensitive to berahyaluronidase or hyaluronidase.
- The decision establishes the first PD-1 inhibitor plus antibody–drug conjugate perioperative regimens for this population, with Merck announcing the approval and the trial conducted with Pfizer and Astellas.