Merck receives positive CHMP opinion for KEYTRUDA plus Padcev

Merck (MRK) announced the European Medicines Agency’s Committee for Medicinal Products for Human Use adopted a positive opinion recommending approval of KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with Padcev, an antibody-drug conjugate, 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 recommendation, which also includes KEYTRUDA SC, will now be reviewed by the European Commission for marketing authorization in the European Union, Iceland, Liechtenstein and Norway, and a final decision is expected by the third quarter of 2026. The recommendation is based on results from the Phase 3 KEYNOTE-905 trial. In the study, KEYTRUDA plus Padcev, as perioperative treatment, demonstrated statistically significant and clinically meaningful improvements in event-free survival, overall survival and pathologic complete response rate versus surgery alone in patients with MIBC who are not eligible for or declined cisplatin-based chemotherapy. The KEYTRUDA plus Padcev regimen reduced the risk of EFS events by 60% versus surgery alone. Median EFS was not reached for the KEYTRUDA plus Padcev regimen versus 15.7 months for surgery alone. KEYTRUDA plus Padcev also reduced the risk of death by 50% versus surgery alone. Median OS was not reached for the KEYTRUDA plus Padcev regimen versus 41.7 months for surgery alone. The trial demonstrated a statistically significant difference in pCR rate.