Merck's KEYTRUDA Plus Padcev Wins EU Approval for Muscle-Invasive Bladder Cancer

The European Commission approved Merck & Co.'s (MRK) KEYTRUDA (pembrolizumab) plus Padcev (enfortumab vedotin-ejfv) as perioperative treatment for adults with resectable muscle-invasive bladder cancer, regardless of cisplatin eligibility, the company announced. The approval was based on the Phase 3 KEYNOTE-B15 trial, in which the combination reduced the risk of event-free survival events by 47% and the risk of death by 35% versus chemotherapy and surgery in cisplatin-eligible patients. The trial showed a pathological complete response rate of 55.8% for the combination, compared with 32.5% for chemotherapy. The approval covers all 27 EU member states, plus Iceland, Liechtenstein and Norway. Merck shares closed Tuesday's trade at $148.30, up 3.25%. In premarket trading, the stock is at $147.65, down 0.44%.