Merck is advancing its cancer treatment offerings in Europe with a significant recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for KEYTRUDA (pembrolizumab) in combination with Padcev (enfortumab vedotin-ejfv) for bladder cancer.
This recommendation targets adults with resectable muscle-invasive bladder cancer (MIBC) who are not eligible for cisplatin-based chemotherapy. The proposed use includes neoadjuvant therapy and continued treatment following radical cystectomy. The next step involves a ruling from the European Commission, anticipated by Q3 2026.
Marjorie Green, a key figure at Merck, highlighted the critical need for new treatment options for patients facing high recurrence risks. The CHMP's backing is based on promising results from the Phase 3 KEYNOTE-905 (EV-303) trial, which demonstrated significant benefits of the combination therapy compared to surgery alone, including improved event-free survival (EFS), overall survival (OS), and pathologic complete response (pCR) rates.
The trial revealed a 60% reduction in the risk of EFS events, while the overall survival rate saw a 50% reduction in mortality risk. These findings underscore the potential of a KEYTRUDA-based regimen to transform treatment paradigms for this patient population, addressing a pressing unmet medical need.