Garsorasib in patients with KRAS G12C-mutated non-small-cell lung cancer: A pooled analysis of phase 1/2 study

Garsorasib, a KRAS G12C inhibitor, has previously demonstrated its efficacy and safety in patients with KRAS G12C-mutated non-small-cell lung cancer (NSCLC). Here, we present long-term follow-up data from a pooled analysis of the phase 1/2 study.

This multicenter, open-label phase 1/2 study enrolled patients with KRAS G12C-mutated, locally advanced or metastatic NSCLC. The primary endpoints for phase 1 were safety and tolerability and for phase 2 objective response rate (ORR) by a blinded independent review committee per RECIST version 1.1. Data was pooled from patients who received garsorasib 600 mg twice daily.

This pooled dataset included 189 patients (N = 66 in phase 1 and N = 123 in phase 2). The median pooled follow-up time was 13.0 months (IQR: 6.7-17.5). The objective response rate was 48.1 % (95 %CI: 40.8-55.5), and disease control rate was 87.8 % (95 %CI: 82.3-92.1). The median duration of response was 12.45 months (95 % CI: 8.31, 14.49), the median progression-free survival was 9.07 months (95 %CI: 7.39-9.76), and the median overall survival was 14.19 months (95 %CI: 13.08-17.54). Treatment-related adverse events of any grade occurred in 96.3 % of patients, with grade ≥ 3 in 49.2 % of patients. No new safety findings were observed, and most of the adverse events were controllable.

This pooled analysis confirmed the robust efficacy and manageable safety of garsorasib in KRAS G12C-mutated NSCLC.

NCT05383898.