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# Merck Keytruda Data Positive in Bladder Cancer
- URL: https://www.fdaweb.com/merck-keytruda-data-positive-in-bladder-cancer/
- Published: 2024-01-26T12:00:00.000Z
- Updated: 2026-09-14T14:21:21.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5156228

Merck says data from its Phase 3 AMBASSADOR (A031501)/KEYNOTE-123 trial evaluating Keytruda (pembrolizumab) are favorable for the therapy as a potential add-on treatment in high-risk patients with localized muscle-invasive urothelial carcinoma and locally advanced resectable urothelial carcinoma.

“At the trial’s first pre-specified interim analysis, after a median follow-up of 22.3 months, Keytruda demonstrated a statistically significant and clinically meaningful improvement in one of the study’s dual primary endpoints of disease-free survival (DFS), reducing the risk of disease recurrence or death by 31% … versus observation in these patients after surgery,” the company says. Median DFS was 29 months for Keytruda and 14 months for observation, it says, adding that the results were consistent regardless of patients’ PD-L1 expression status. The trial’s other primary endpoint, overall survival, did not reach statistical significance at the time of this interim analysis.