Dr. Skoulidis on the Results of Subgroup Analyses of the CodeBreaK 100 Trial in KRAS G12C-Mutant NSCLC

Ferdinandos Skoulidis, MD, PhD, MRCP, assistant professor, Department of Thoracic/Head and Neck Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, discusses the results of a subgroup analysis from the phase 2 CodeBreaK 100 trial (NCT03600883) in patients with KRAS G12C-mutant non–small cell lung cancer (NSCLC).

Findings from the registrational CodeBreaK 100 study demonstrated a 37.1% objective response rate (ORR) with sotorasib (Lumakras) in patients with pretreated KRAS G12C-mutant NSCLC. The median progression-free survival was 6.8 months. Notably, based on these findings, sotorasib was approved by the FDA on May 28, 2021, for the treatment of patients with KRAS G12C-mutated NSCLC who have received at least 1 prior systemic therapy.

During the 2021 ASCO Annual Meeting, overall survival (OS) data and exploratory subgroup analyses from the CodeBreaK 100 trial were presented virtually. The results revealed a median overall survival of 12.5 months with sotorasib. Additionally, sotorasib demonstrated efficacy across various prespecified patient and molecular subgroups. Notably, sotorasib was effective in patients whose tumors harbored STK11 mutations, which is a population that has inferior outcomes with standard therapies, concludes Skoulidis.