Merck reports ‘positive’ results from Phase 3 KEYNOTE-B15 trial

Merck (MRK) announced positive topline results from the Phase 3 KEYNOTE-B15 trial in patients with muscle-invasive bladder cancer who are eligible for cisplatin-based chemotherapy. The trial showed Keytruda plus Padcev, given as neoadjuvant and adjuvant treatment, demonstrated a statistically significant and clinically meaningful improvement in event-free survival, overall survival and pathologic complete response rates versus neoadjuvant chemotherapy and surgery. “The persistent risk of recurrence in cis-eligible patients with muscle-invasive bladder cancer, despite recent advances, underscores the continued need for effective perioperative treatments,” said Dr. Matthew Galsky, Lillian and Howard Stratton Professor of Medicine, director of genitourinary medical oncology, Mount Sinai Tisch Cancer Center, and KEYNOTE-B15 principal study investigator. “The strength of these data demonstrates that pembrolizumab plus enfortumab vedotin-given before and after surgery-has the potential to significantly improve survival outcomes.”