Merck announces AMBASSADOR trial meets one of two primary endpoints of DFS

Merck (MRK) announced that the Phase 3 AMBASSADOR trial evaluating Keytruda, Merck’s anti-PD-1 therapy, met one of its dual primary endpoints of disease-free survival, or DFS, for the adjuvant treatment of patients with localized muscle-invasive urothelial carcinoma, or MIUC, and locally advanced urothelial carcinoma versus observation. At a pre-specified interim analysis review conducted by an independent Data Monitoring Committee, Keytruda demonstrated a statistically significant and clinically meaningful improvement in DFS versus observation in these patients after surgery. The trial will continue to evaluate its other dual primary endpoint of overall survival, or OS. The safety profile of Keytruda in this trial was consistent with that observed in previously reported studies; no new safety signals were identified. Results will be presented at an upcoming medical meeting and discussed with regulatory authorities. This trial was sponsored by the U.S. National Cancer Institute, or NCI, part of the National Institutes of Health. Alliance for Clinical Trials in Oncology designed and led the trial with funding from the NCI and participation from all the National Clinical Trials Network Groups. Merck provided funding and support through a cooperative research and development agreement between Merck and NCI. Merck has an extensive clinical development program evaluating Keytruda as monotherapy and in combination with other anti-cancer therapies across all stages of bladder cancer, including non-muscle-invasive, muscle-invasive and metastatic. Phase 3 studies in muscle-invasive bladder cancer include the KEYNOTE-866 trial, as well as the Phase 3 KEYNOTE-B15 and Phase 3 KEYNOTE-905 trials, which are being conducted in collaboration with Seagen (SGEN) and Astellas (ALPMY).