MRK Clinical trials

KEYTRUDA® (pembrolizumab) plus Padcev® (enfortumab vedotin-ejfv) Significantly Improved Event-Free and Overall Survival and Pathologic Complete Response Rate for Certain Patients with Muscle-Invasive Bladder Cancer When Given Before and After Surgery

Published August 12, 2025 at 09:33 AM

RAHWAY, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced positive topline results from the Phase 3 KEYNOTE-905 trial (also known as EV-303) in patients with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-based chemotherapy. In this study, KEYTRUDA® (pembrolizumab) plus Padcev (enfortumab vedotin-ejfv), given before and after surgery (radical cystectomy), demonstrated a statistically significant and clinically me

Related Questions

How will the positive Phase 3 results affect Merck's (MRK) stock price in the short term? What is the expected timeline for FDA submission and potential approval of the pembrolizumab + enfortumab vedotin combination for MIBC? How does this trial outcome compare to existing first‑line therapies for muscle‑invasive bladder cancer, especially cisplatin‑ineligible patients? What market size and revenue potential does Merck anticipate for this indication, and how will it impact overall earnings guidance? Are there any safety or tolerability signals in the topline data that could influence market perception or regulatory review? What are the projected manufacturing and supply‑chain implications for scaling Padcev (enfortumab vedotin) alongside KEYTRUDA? How might this data shift the competitive landscape with other immunotherapy or ADC developers targeting bladder cancer? Will the results trigger any updates to Merck’s partnership agreements or trigger milestone payments to collaborators? What are the key inclusion/exclusion criteria of the KEYNOTE‑905 trial that could affect the broader patient population eligibility? How will the combination’s efficacy metrics (event‑free survival, overall survival, pCR) influence payer reimbursement strategies? Is there any indication that Merck will expand the combination into earlier‑line or adjuvant settings based on these results?