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Merck & Co Inc (NYSE:MRK) announced that the Phase 3 AMBASSADOR (A031501) trial (KEYNOTE-123) evaluating Keytruda met one of its dual primary endpoints of disease-free survival for the adjuvant treatment of localized muscle-invasive urothelial carcinoma and locally advanced urothelial carcinoma.
Also Read: Merck-Eisai Partnered Two Keytruda/Lenvima Combo Trials Flunk In Certain Types Of Lung Cancer.
At a pre-specified interim analysis review conducted by an independent Data Monitoring Committee, Keytruda demonstrated a statistically significant and clinically meaningful improvement in disease-free survival versus observation in these patients after surgery.
The trial will continue to evaluate its other dual primary endpoint of overall survival (OS).
Phase 3 studies in muscle-invasive bladder cancer include the KEYNOTE-866 trial and the Phase 3 KEYNOTE-B15 and Phase 3 KEYNOTE-905 trials, which are being conducted in collaboration with Seagen Inc (NASDAQ: SGEN) and Astellas Pharma Inc (OTC: ALPMF) (OTC: ALPMY).
Price Action: MRK shares are up 0.70% at $102.89 on the last check Thursday.
