Merck received European Commission approval for KEYTRUDA in combination with the antibody-drug conjugate Padcev. The regimen treats adult patients with resectable muscle-invasive bladder cancer who are ineligible for cisplatin-based chemotherapy. This decision establishes the first PD-1 inhibitor plus ADC combination available for these patients in the European Union.
The approval follows results from the pivotal Phase 3 KEYNOTE-905 trial. The combination therapy reduced the risk of event-free survival events by 60% compared to surgery alone. It also reduced the risk of death by 50%. This treatment addresses a significant unmet need and offers a new potential standard of care.