Merck wins CHMP positive opinion for KEYTRUDA plus Padcev in resectable MIBC

CHMP opinion and next steps

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of KEYTRUDA (pembrolizumab) plus Padcev (enfortumab vedotin-ejfv) as neoadjuvant treatment and continued after radical cystectomy as adjuvant treatment for adults with resectable muscle‑invasive bladder cancer (MIBC). The recommendation includes KEYTRUDA SC and will be reviewed by the European Commission for marketing authorization in the EU, Iceland, Liechtenstein and Norway, with a final decision expected by the fourth quarter of 2026.

KEYNOTE‑B15 Phase 3 results

The recommendation is based on the Phase 3 KEYNOTE‑B15 trial (EV‑304), conducted with Pfizer and Astellas, which compared KEYTRUDA plus Padcev as perioperative treatment to neoadjuvant gemcitabine and cisplatin followed by surgery in cisplatin‑eligible patients. The regimen reduced the risk of event‑free survival (EFS) events by 47% (HR=0.53; 95% CI 0.41–0.70; p<0.0001) and reduced the risk of death by 35% (HR=0.65; 95% CI 0.48–0.89; p=0.0029). Pathologic complete response (pCR) was 55.8% versus 32.5% (p<0.0001).

Regulatory context

In June 2026 the European Commission approved KEYTRUDA plus Padcev as perioperative treatment for adults with resectable MIBC who are ineligible for cisplatin based on the Phase 3 KEYNOTE‑905 trial. In July 2026 the U.S. FDA approved KEYTRUDA in combination with Padcev as neoadjuvant then adjuvant treatment for adults with MIBC based on KEYNOTE‑B15, making it the first PD‑1 inhibitor plus antibody‑drug conjugate regimen approved in the U.S. for MIBC regardless of cisplatin eligibility.

Clinical background

Bladder cancer is the eighth most common cancer worldwide, with more than 635,000 diagnoses annually. In Europe there were an estimated 224,700 diagnoses and over 70,300 deaths in 2022, and about 25% of newly diagnosed cases are muscle‑invasive. Standard care is neoadjuvant cisplatin‑based chemotherapy followed by surgery, but nearly half of patients treated this way experience recurrence and up to half of MIBC patients are ineligible for cisplatin.