Pfizer and Astellas said their antibody-drug conjugate Padcev, combined with Merck’s immunotherapy Keytruda, extended survival for patients with cisplatin-ineligible muscle-invasive bladder cancer when administered before and after radical cystectomy. The regimen met the Phase 3 EV-303/KEYNOTE-905 trial’s primary endpoint of event-free survival and also delivered statistically significant improvements in overall survival and pathologic complete response compared with surgery alone. The open-label study enrolled 595 patients who could not receive, or declined, cisplatin chemotherapy—about half of all patients with this aggressive form of the disease. Investigators reported that the safety profile of the combination was consistent with that of the individual drugs, with no new signals detected. Padcev plus Keytruda is already approved for metastatic urothelial cancer; the companies said they will discuss the new perioperative data with global regulators, positioning the regimen as the first systemic therapy to show a survival benefit in this early setting. If cleared, the combination could replace surgery-only care for thousands of high-risk bladder-cancer patients who currently lack effective options.