RAHWAY, New Jersey, May 24, 2026
Merck announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of KEYTRUDA® (pembrolizumab) in combination with Padcev® (enfortumab vedotin-ejfv) as perioperative treatment for adults with cisplatin-ineligible resectable muscle-invasive bladder cancer (MIBC). If approved by the European Commission, the regimen would become the first PD-1 inhibitor plus antibody-drug conjugate (ADC) combination available for this patient population across the European Union.
Phase 3 KEYNOTE-905 Trial Demonstrated Significant Survival Benefits
The CHMP recommendation was supported by results from the Phase 3 KEYNOTE-905/EV-303 trial conducted in collaboration with Pfizer and Astellas Pharma. The study evaluated perioperative KEYTRUDA plus Padcev versus surgery alone in patients with muscle-invasive bladder cancer who were ineligible for or declined cisplatin-based chemotherapy. Merck reported that the combination reduced the risk of event-free survival events by 60% and reduced the risk of death by 50% compared with surgery alone. The regimen also delivered a substantially higher pathologic complete response rate of 57.1% versus 8.6% for surgery alone.
Combination Could Address Major Treatment Gap in Cisplatin-Ineligible Patients
Muscle-invasive bladder cancer patients who cannot receive cisplatin-based chemotherapy currently face limited treatment options and high rates of recurrence after surgery. Merck stated that the KEYTRUDA plus Padcev combination offers a new perioperative strategy using immunotherapy alongside an ADC before surgery and continuing after cystectomy as adjuvant treatment. The regimen already received U.S. FDA approval in November 2025 for this indication, further strengthening its global regulatory momentum.
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Merck Expands Immunotherapy Leadership in Genitourinary Cancers
Merck continues to advance one of the industry’s largest immuno-oncology development programs, with more than 2,800 KEYTRUDA clinical trials underway across multiple cancer types and disease stages. The company is actively expanding research in genitourinary cancers including bladder, kidney, and prostate cancer through multiple combination approaches involving immunotherapies, targeted therapies, and ADCs. The European Commission is expected to issue a final decision on the CHMP recommendation during the third quarter of 2026.
Source: Merck, press release
