Multicenter phase 2 trial of IBI351 monotherapy for advanced non-small cell lung cancer with KRAS G12C mutation

IBI351 is a covalent and irreversible inhibitor of KRAS G12C. A multicenter phase 2 trial in China evaluated IBI351 monotherapy after failure of standard therapy in patients with advanced non-small cell lung cancer (aNSCLC) with KRAS G12C mutation. Patients received oral IBI351 600 mg twice daily. Objective response rate assessed by independent radiological review committee was 49.1% (95% CI 39.7-58.6) while disease control rate was 90.5% (83.7-95.2). Median duration of response was not reached, and median progression-free survival was 9.7 months (95% CI 5.6-11.0), while overall survival data were immature. Treatment-related adverse events occurred in 92.2% of patients; grade ≥3 TRAEs in 41.4%; TRAEs leading to discontinuation of treatment in 7.8%. The authors conclude that IBI153 monotherapy demonstrated promising and sustained efficacy with manageable safety among previously treated patients with aNSCLC with KRAS G12C mutation.