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# Keytruda/Padcev Study in Bladder Cancer Positive: Merck
- URL: https://www.fdaweb.com/keytruda-padcev-study-in-bladder-cancer-positive-merck/
- Published: 2025-08-12T12:00:00.000Z
- Updated: 2026-09-14T15:18:47.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159668

Merck says the combination of Keytruda (pembrolizumab) and Pfizer’s Padcev (enfortumab vedotin-ejfv), given before and after surgery, significantly improved survival outcomes in patients with muscle-invasive bladder cancer who cannot receive cisplatin-based chemotherapy. In the Phase 3 KEYNOTE-905 (EV-303) trial, the regimen achieved statistically significant and clinically meaningful gains in event-free survival, overall survival, and pathologic complete response rate compared with surgery alone — marking the first time a systemic perioperative treatment has extended survival over standard surgical care in this patient group, according to the company.

Merck says the the safety profile matched that of the individual drugs, with no new concerns identified. It plans to share the results with regulators worldwide and present the data at an upcoming medical meeting. The company developed the trial in collaboration with Pfizer (formerly Seagen) and Astellas, building on prior success of the combination in advanced urothelial cancer.

Keytruda plus Padcev is currently approved in the U.S. for treating locally advanced or metastatic urothelial cancer.