The European Union Approves Merck's Keytruda In Combination With Padcev As Neoadjuvant Treatment And Then Continued After Radical Cystectomy As Adjuvant Treatment, For Adults With Resectable Muscle-invasive Bladder Cancer Who Are Ineligible For Cisplatin-containing Chemotherapy

This approval is based on results from the pivotal Phase 3 KEYNOTE-905 trial (also known as EV-303), which was conducted in collaboration with Pfizer and Astellas. In the study, KEYTRUDA plus Padcev, as perioperative treatment, demonstrated statistically significant and clinically meaningful improvements in event-free survival (EFS), overall survival (OS) and pathologic complete response (pCR) rate versus surgery alone in patients with MIBC who are not eligible for or declined cisplatin-based chemotherapy. KEYTRUDA plus Padcev reduced the risk of EFS events by 60% (HR=0.40 [95% CI, 0.28-0.57]; p<0.0001) versus surgery alone. Median EFS was not reached (NR) (95% CI, 37.3-NR) for KEYTRUDA plus Padcev versus 15.7 months (95% CI, 10.3-20.5) for surgery alone. KEYTRUDA plus Padcev also reduced the risk of death by 50% (HR=0.50 [95% CI, 0.33-0.74]; p=0.0002) versus surgery alone. Median OS was NR (95% CI, NR-NR) for KEYTRUDA plus Padcev versus 41.7 months (95% CI, 31.8-NR) for surgery alone. The trial demonstrated a statistically significant difference in pCR rate (57.1% [95% CI: 49.3, 64.6] vs. 8.6% [95% CI: 4.9, 13.8]; p<0.0001). The approval follows a positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), received in May 2026.

"Patients with resectable muscle-invasive bladder cancer who are ineligible for cisplatin‑containing chemotherapy face an aggressive disease and few effective therapies, with surgery alone as the longstanding standard of care," said Professor Christof Vulsteke, head of Integrated Cancer Center Ghent (IKG) and Clinical Trial Unit Oncology Ghent and KEYNOTE-905 principal investigator. "Based on robust data from the KEYNOTE-905 trial, this approval marks a turning point in bladder cancer care. It introduces a potentially practice-changing perioperative treatment option that may significantly improve outcomes and extend survival for this underserved patient population across the European Union."

"For patients with resectable muscle-invasive bladder cancer in Europe, this approval represents a meaningful advance after years of limited progress in the field," said Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories. "As the first PD-1 inhibitor plus antibody-drug conjugate regimen approved in this setting, this treatment is poised to address a crucial unmet need, reflecting our continued commitment to delivering innovative KEYTRUDA-based therapies to patients with bladder cancer worldwide."

This approval authorizes marketing of this KEYTRUDA treatment regimen for this indication in all 27 EU member states, as well as Iceland, Liechtenstein and Norway. Timing for commercial availability of KEYTRUDA for this indication in individual EU countries will depend on multiple factors, including the completion of national reimbursement procedures.

In November 2025, KEYTRUDA and KEYTRUDA QLEX, each in combination with Padcev, were approved by the U.S. Food and Drug Administration (FDA), as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment, for the treatment of adult patients with MIBC who are ineligible for cisplatin-based chemotherapy.