Merck has initiated a Phase 3 clinical trial (NCT06345729) to evaluate MK-1084, an oral KRAS G12C inhibitor, in combination with KEYTRUDA for the first-line treatment of metastatic non-small cell lung cancer (NSCLC) with KRAS G12C mutations and PD-L1 expression (TPS ≥50%).
MK-1084 is a potent and specific KRAS G12C covalent inhibitor being developed through a collaboration between Merck, Taiho Pharmaceutical Co. Ltd, and Astex Pharmaceuticals. KRAS mutations are common in various cancers, including NSCLC, where the KRAS G12C mutation is particularly prevalent.
The Phase 3 trial will enroll approximately 600 patients globally and compare MK-1084 plus KEYTRUDA to KEYTRUDA plus placebo. The primary endpoints are progression-free survival and overall survival, while secondary endpoints include objective response rate and duration of response.
Preliminary data from an earlier Phase 1 trial showed a manageable safety profile and promising anti-tumor activity for the MK-1084 and KEYTRUDA combination. The current Phase 3 trial aims to further evaluate the efficacy and safety of this combination in a larger patient population.
Lung cancer, particularly NSCLC, remains a leading cause of cancer-related deaths globally. This Phase 3 trial represents a significant step towards developing new treatment options for patients with KRAS G12C-mutated metastatic NSCLC.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
