Merck & Co., also known as MSD in areas outside the U.S. and Canada, revealed on Thursday that they have begun a Phase 3 clinical trial. The trial is designed to evaluate MK-1084, an exploratory oral selective KRAS G12C inhibitor. This will be combined with KEYTRUDA for initial treatment of some patients suffering from metastatic non-small cell lung cancer (NSCLC). These targeted patients will carry tumors housing KRAS G12C mutations and expressing PD-L1.
The initiated Phase 3 trial is a randomized, double-blind and multicenter clinical trial. Here, MK-1084 will be assessed once every day along with KEYTRUDA, which will be administered every three weeks. This combination will also be compared to a combination of KEYTRUDA and a placebo.
The global trial aims to enroll around 600 participants. It will primarily focus on progression-free survival and overall survival. Additional crucial secondary endpoints are the objective response rate coupled with the duration of the response.
Maintaining development through a partnership with Taiho Pharmaceutical Co. Ltd and Astex Pharmaceuticals (UK), a fully owned subsidiary of Otsuka Pharmaceutical Co., Ltd, MK-1084 first announced this collaboration in January 2020.
