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.<\/p>\n
The trial will now continue to evaluate its other dual primary endpoint of overall survival or OS. <\/p>\n
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.<\/p>\n
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.<\/p>\n
KEYTRUDA demonstrated a statistically significant and clinically meaningful improvement in DFS versus observation in these patients after surgery.<\/p>\n
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.<\/p>\n
The company plans to present the trial results at an upcoming medical meeting, and will also be discussed with regulatory authorities.<\/p>\n
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.<\/p>\n
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.<\/p>\n
For More Such Health News, visit rttnews.com <\/p>\n