Sosimerasib for Patients With Locally Advanced or Metastatic KRAS G12C-Mutated Non-Small Cell Lung Cancer
According to results from a phase 2 study, sosimerasib demonstrated promising efficacy and safety among patients with locally advanced or metastatic KRAS G12C-mutated non-small cell lung cancer (NSCLC).
These data were first presented by Jia Zhong, MD, Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, China, at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois.
In this open-label study, researchers enrolled 145 patients who experienced disease progression after treatment with platinum-based chemotherapy and/or anti-PD-1/PD-L1 inhibitors to receive 500 mg of once daily sosimerasib. The primary end point was objective response rate (ORR). Key secondary end points included disease control rate, time to response, progression-free survival (PFS), and safety.
At a median follow-up of 6.8 months, the ORR was 52.4% with a median time to response of 1.4 months and a disease control rate of 87.6%. Median PFS was 7.2 months. Treatment-related adverse events occurred in 95.2% of patients and grade 3/4 treatment-related adverse events occurred in 40% of patients. The most common events included alanine aminotransferase increase (66.2%), aspartate aminotransferase increase (62.8%), anemia (31.7%), gamma-glutamyl transferase increase (26.2%), and blood alkaline phosphatase increase (22.1%). Treatment-related adverse events led to drug interruptions in 24.1% of patients, dose reductions in 10.3%, and permanent discontinuation in 2.1%. No fatal treatment-related adverse events were reported.
“Sosimerasib monotherapy has shown promising anti-tumor activity with manageable safety profile in locally advanced/metastatic NSCLC patients harboring KRAS G12C mutation,” concluded Dr Zhong et al. “This study is still ongoing and longer follow-up will provide more solid evidence.”
Source:
Zhong J, Zhou J, Chu Q, et al. Sosimerasib monotherapy in patients with previously treated KRAS G12C–mutated non-small cell lung cancer: Primary results of a phase 2 study. May 30-June 3, 2025; Chicago, IL. Abstract 8520
