Merck & Co., Inc. (MRK) on Thursday announced that its KEYTRUDA (pembrolizumab) in Phase 3 trial met one of its dual primary endpoints of disease-free survival or DFS in certain patients with muscle-invasive urothelial carcinoma or MIUC after surgery. The company said it is the first positive study for KEYTRUDA as adjuvant therapy for these patients.
The trial will now continue to evaluate its other dual primary endpoint of overall survival or OS.
KEYTRUDA is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells.
In the Phase 3 AMBASSADOR (A031501) trial (KEYNOTE-123) evaluating KEYTRUDA, Merck said its anti-PD-1 therapy achieved DFS for the adjuvant treatment of patients with localized MIUC and locally advanced urothelial carcinoma versus observation.
KEYTRUDA demonstrated a statistically significant and clinically meaningful improvement in DFS versus observation in these patients after surgery.
Merck said the safety profile of KEYTRUDA in this trial was consistent with that observed in previously reported studies, and that no new safety signals were identified.
The company plans to present the trial results at an upcoming medical meeting, and will also be discussed with regulatory authorities.
The trial was sponsored by the U.S. National Cancer Institute or NCI, part of the National Institutes of Health. Merck provided funding and support through a Cooperative Research and Development Agreement between Merck and NCI.
Merck noted that it 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.
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