RAHWAY, N.J. — September 18, 2026
Merck announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending KEYTRUDA® (pembrolizumab) in combination with Padcev® (enfortumab vedotin-ejfv) as perioperative treatment for adults with resectable muscle-invasive bladder cancer (MIBC). The proposed regimen includes neoadjuvant treatment followed by continued therapy after radical cystectomy as adjuvant treatment. The recommendation will now be reviewed by the European Commission, with a final decision expected in the fourth quarter of 2026.
KEYNOTE-B15 Demonstrates Significant Survival Improvements
The CHMP recommendation is based on results from the Phase 3 KEYNOTE-B15 trial, also known as EV-304, conducted in collaboration with Pfizer and Astellas. In patients eligible for cisplatin-based chemotherapy, perioperative KEYTRUDA plus Padcev reduced the risk of event-free survival events by 47% compared with neoadjuvant gemcitabine and cisplatin followed by surgery (HR 0.53; p<0.0001). The combination also reduced the risk of death by 35% (HR 0.65; p=0.0029). The trial demonstrated a pathologic complete response rate of 55.8% with KEYTRUDA plus Padcev compared with 32.5% with neoadjuvant chemotherapy.
Regimen Expands Treatment Options Across Cisplatin Eligibility
If approved, KEYTRUDA plus Padcev would become the first and only PD-1 inhibitor plus antibody-drug conjugate regimen approved in the European Union for resectable MIBC regardless of cisplatin eligibility, according to Merck. The potential indication would expand on the European Commission’s June 2026 approval of KEYTRUDA plus Padcev for patients with resectable MIBC who are ineligible for cisplatin-containing chemotherapy, based on KEYNOTE-905. In the United States, the FDA approved the perioperative combination in July 2026 based on KEYNOTE-B15, making it the first such PD-1 inhibitor plus ADC regimen approved in the U.S. for MIBC regardless of cisplatin eligibility.
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Merck Advances Earlier-Stage Bladder Cancer Strategy
The positive CHMP opinion strengthens Merck’s strategy of evaluating KEYTRUDA-based combinations earlier in the treatment journey, particularly in settings where recurrence remains a major challenge. Bladder cancer is among the most common cancers worldwide, and approximately 25% of newly diagnosed cases are estimated to be muscle-invasive. Merck is conducting a broad genitourinary cancer development program involving more than 50 ongoing clinical trials and more than 22,000 patients, while its broader early-stage cancer program includes more than 30 registrational studies across multiple cancer types. The potential European approval would further expand the role of KEYTRUDA plus Padcev in earlier-stage bladder canc
Source : Merck press release
