Merck & Co. Inc. (NYSE:MRK) on Wednesday shared 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.
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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.
The trial, evaluating Merck’s Keytruda plus Padcev, was conducted in collaboration with Pfizer Inc (NYSE:PFE) and Astellas Pharma Inc (OTC:ALPMF) (OTC:ALPMY).
The safety profile of Keytruda plus Padcev in this study was consistent with the known safety profiles of each agent. No new safety signals were identified with the combination.
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The companies plan to share these results with regulatory authorities worldwide for potential regulatory filings and will present the data at an upcoming medical meeting.
Three additional Phase 3 studies are currently evaluating Keytruda across all stages of bladder cancer, including non-muscle-invasive, muscle-invasive, and metastatic.
Two of these studies are in MIBC, including KEYNOTE-866 and KEYNOTE-992.
Keytruda is also being evaluated in combination with Bacillus Calmette-Guerin (BCG) in patients with NMIBC in KEYNOTE-676.
MRK Price Action: Merck stock is up 0.37% at $98.63 at publication on Wednesday.
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