China-based InxMed has published data from a Phase Ib/II study of ifebemtinib, a FAK inhibitor, combined with KRAS G12C inhibitor garsorasib, as a chemotherapy-free, dual-oral first-line regimen for KRAS G12C-mutant NSCLC. In 31 evaluable treatment-naive patients, the combination achieved an objective response rate (ORR) of 87.1%, a median progression-free survival (PFS) of 22.3 months and a median overall survival (OS) of 27.8 months, with a manageable safety profile (Grade ≥3 TRAEs in 24%).

The synergy is hypothesised to derive from FAK inhibition blocking compensatory FAK-YAP signalling and remodelling the tumour microenvironment (TME) to enhance T-cell infiltration. Ifebemtinib holds three Breakthrough Therapy Designations (BTD) from China's National Medical Products Administration (NMPA) and a Fast Track designation in the US.

A randomised, controlled Phase III confirmatory trial (NCT07174908) is underway across approximately 90 sites in China to support registrational filing. If positive, the data could establish a new targeted standard of care for first-line KRAS G12C-mutant NSCLC and validate FAK inhibition as a rational combination strategy across RAS-mutant tumours.