Garsorasib in Patients with KRAS G12C-Mutated Non-Small-Cell Lung Cancer: A Pooled Analysis of Phase 1/2 Study
Mené sur 189 patients atteints d'un cancer du poumon non à petites cellules avec mutation G12C au niveau du gène KRAS (durée médiane de suivi : 13 mois), cet essai de phase I/II évalue l'efficacité, du point de vue du taux de réponse objective, et la toxicité du garsorasib (un inhibiteur de KRAS G12C)
Introduction: 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.
Methods: 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.
Results: 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.
Conclusion: This pooled analysis confirmed the robust efficacy and manageable safety of garsorasib in KRAS G12C-mutated NSCLC.
European Journal of Cancer , résumé, 2025