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KEYTRUDA® (pembrolizumab) Plus Padcev® (enfortumab vedotin-ejfv) Significantly Improved Event-Free Survival, Overall Survival and Pathologic Complete Response Rates for Cisplatin-Eligible Patients with MIBC When Given Before and After Surgery
RAHWAY, N.J., December 17, 2025--Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced positive topline results from the Phase 3 KEYNOTE-B15 trial (also known as EV-304) in patients with muscle-invasive bladder cancer (MIBC) who are eligible for cisplatin-based chemotherapy. The trial showed KEYTRUDA® (pembrolizumab) plus Padcev ® (enfortumab vedotin-ejfv), given as neoadjuvant and adjuvant treatment (before and after surgery), demonstrated a statistically signifi
About this update from Merck & Company, Inc.
[{"type":"image","alt":"","displaySize":"","headline":null,"caption":"","credit":null,"className":"","disableSlideshowImg":false,"size":{"original":{"width":480,"height":217,"url":"https://media.zenfs.com/en/business-wire.com/33bebd2e1be5e24a31fbe0216dc69587"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/wOR8bT3uaGe6.wHo9CWEKA--/YXBwaWQ9aGlnaGxhbmRlcjt3PTk2MDtoPTQzNDtjZj13ZWJw/https://media.zenfs.com/en/business-wire.com/33bebd2e1be5e24a31fbe0216dc69587","width":480,"height":217}},"lazy":false},{"type":"text","content":"First and only immunotherapy plus ADC regimen, used perioperatively, to extend survival for cisplatin-eligible patients with MIBC","length":129,"tagName":"p","attribs":{}},{"type":"text","content":"RAHWAY, N.J., December 17, 2025--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced positive topline results from the Phase 3 KEYNOTE-B15 trial (also known as EV-304) in patients with muscle-invasive bladder cancer (MIBC) who are eligible for cisplatin-based chemotherapy. The trial showed KEYTRUDA® (pembrolizumab) plus Padcev ® (enfortumab vedotin-ejfv), given as neoadjuvant and adjuvant treatment (before and after surgery), demonstrated a statistically significant and clinically meaningful improvement in event-free survival (EFS), overall survival (OS) and pathologic complete response (pCR) rates versus neoadjuvant chemotherapy and surgery.","length":701,"tagName":"p"},{"type":"text","content":""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."","length":590,"tagName":"p"},{"type":"text","content":"The trial, evaluating Merck’s KEYTRUDA, an anti-PD-1 therapy, plus Padcev, an antibody-drug conjugate (ADC), was conducted in collaboration with Pfizer and Astellas and builds on the clinical success of this combination in locally advanced or metastatic urothelia...