European Commission Approves KEYTRUDA® (pembrolizumab) Plus Padcev® (enfortumab vedotin-ejfv) as Perioperative Treatment for Adults With Resectable Muscle-Invasive Bladder Cancer (MIBC)

First and only PD-1 inhibitor plus antibody-drug conjugate regimen approved in the European Union (EU) for patients with MIBC regardless of cisplatin eligibility

RAHWAY, N.J., October 21, 2026--Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the European Commission (EC) has approved KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, in combination with Padcev® (enfortumab vedotin-ejfv), as neoadjuvant treatment and then continued after radical cystectomy as adjuvant treatment for adults with resectable muscle-invasive bladder cancer (MIBC). This approval, which also covers KEYTRUDA SC® [known as KEYTRUDA QLEXTM (pembrolizumab and berahyaluronidase alfa-pmph) in the U.S.], marks the first and only PD-1 inhibitor plus antibody-drug conjugate (ADC) regimen available for patients with MIBC regardless of cisplatin eligibility in the European Union (EU).

"Although cisplatin-based chemotherapy has been a standard treatment approach for many patients with muscle-invasive bladder cancer, recurrence remains a significant challenge," said Dr. Alfonso Gómez de Liaño, Hospital Universitario Insular de Gran Canaria, and KEYNOTE-B15 primary investigator. "Based on results from the KEYNOTE-B15 trial, today's approval is a meaningful advance for patients with muscle-invasive bladder cancer in the European Union, extending this chemotherapy-free perioperative treatment option to patients regardless of cisplatin eligibility."

"Building on the previous approval of KEYTRUDA plus Padcev in the European Union less than six months ago, we're pleased to bring this important treatment option to a broader patient population as the first PD-1 inhibitor plus antibody-drug conjugate regimen approved for people with muscle-invasive bladder cancer regardless of cisplatin eligibility," said Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories. "This approval represents encouraging progress in bladder cancer care and underscores our commitment to addressing the needs of people who are living with this disease."

The EC approval is based on results from the Phase 3 KEYNOTE-B15 trial (also known as EV-304), which was conducted in collaboration with Pfizer and Astellas. In the study, KEYTRUDA plus Padcev, as perioperative treatment, demonstrated a statistically significant improvement in event-free survival (EFS), reducing the risk of EFS events (defined as disease progression, recurrence or death) by 47% (HR=0.53 [95% CI, 0.41-0.70]; p<0.0001; 87/405 [21%] versus 146/403 [36%]) in patients with MIBC who are eligible for cisplatin-based chemotherapy compared to neoadjuvant chemotherapy (gemcitabine and cisplatin) and surgery. KEYTRUDA plus Padcev also demonstrated a statistically significant improvement in overall survival (OS), reducing the risk of death by 35% (HR=0.65 [95% CI, 0.48-0.89]; p=0.0029; 69/405 [17%] versus 99/403 [25%]) in these patients when compared to neoadjuvant chemotherapy and surgery. The trial showed KEYTRUDA plus Padcev demonstrated a statistically significant improvement in pathologic complete response (pCR) rate compared to neoadjuvant chemotherapy (55.8% [95% CI: 50.8, 60.7] versus 32.5% [95% CI: 28.0, 37.3]; p<0.0001). The approval follows a positive recommendation issued by the European Medicines Agency's Committee for Medicinal Products for Human Use in September 2026.