Merck's KEYTRUDA Combo Gets EU Nod for Muscle-Invasive Bladder Cancer

Merck has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommending KEYTRUDA plus Padcev for adults with resectable muscle-invasive bladder cancer. The CHMP recommendation is based on results from the Phase 3 KEYNOTE-B15 trial, which showed improvements in event-free survival, overall survival, and pathologic complete response rates.

According to Dr. Marjorie Green, senior vice president of oncology, global clinical development, Merck Research Laboratories, 'Despite advances in the treatment of muscle-invasive bladder cancer, recurrence remains a significant concern for many patients regardless of cisplatin eligibility.'

The KEYNOTE-B15 trial results showed that KEYTRUDA plus Padcev reduced the risk of event-free survival events by 47% compared to neoadjuvant chemotherapy and surgery. The overall survival results also showed a 35% reduction in the risk of death, and pathologic complete response improved to 55.8% from 32.5%. Merck's KEYTRUDA is an anti-PD-1 therapy used in multiple cancer indications.

The European Commission will review the CHMP recommendation for marketing authorization in the European Union, Iceland, Liechtenstein, and Norway, with a final decision expected in the fourth quarter of 2026.