Merck initiates Phase 3 clinical trial of MK-1084

Merck announced it has initiated a Phase 3 clinical trial evaluating MK-1084, an investigational oral selective KRAS G12C inhibitor, in combination with KEYTRUDA for the first-line treatment of certain patients with metastatic non-small cell lung cancer whose tumors harbor KRAS G12C mutations and express PD-L1. Merck has initiated a Phase 3, randomized, double-blind, multicenter clinical trial evaluating once daily MK-1084 in combination with KEYTRUDA administered once every three weeks compared with KEYTRUDA plus placebo in previously untreated patients with KRAS G12C-mutated metastatic NSCLC with a PD-L1 TPS greater than or equal to50%. The trial will enroll approximately 600 patients globally. The primary endpoints of the study are progression-free survival and overall survival, and key secondary endpoints include objective response rate and duration of response. MK-1084 is currently being evaluated in a Phase 1, open-label multicenter clinical trial to assess safety, tolerability, pharmacokinetics and efficacy of MK-1084 as monotherapy and as part of various combination therapies in patients with KRAS G12C mutant advanced solid tumors. Preliminary safety and efficacy data from this trial were previously presented at the European Society for Medical Oncology Congress in 2023.