InxMed compound combination shows promise in NSCLC study published in The Lancet Respiratory Medicine

InxMed Co., Ltd announced the publication of clinical results for its drug combination, ifebemtinib and garsorasib, in The Lancet Respiratory Medicine. The combination was studied as a first-line treatment for non-small cell lung cancer (NSCLC) harboring the KRAS G12C mutation.

Ifebemtinib, a selective focal adhesion kinase (FAK) inhibitor, and garsorasib, a KRAS G12C inhibitor, were evaluated in a Phase Ib/II trial for patients with KRAS G12C-mutated solid tumors. The published data specifically concerns 33 patients with first-line NSCLC and the KRAS G12C mutation, treated with an all-oral, chemotherapy-free regimen. This approach aims to overcome resistance mechanisms that have limited single-agent KRAS G12C inhibitors in first-line settings.

The study reported an objective response rate (cORR) of 82% across all 33 patients and 87% in evaluable patients, with tumor shrinkage observed in all. The median progression-free survival (mPFS) reached 22.3 months, and the median overall survival (OS) was 27.8 months, although the OS data remained immature. Most treatment-emergent adverse events were mild to moderate, with 33% experiencing Grade 3 or 4 events, and no treatment-related deaths were reported.

"The publication of our long-term follow-up data in The Lancet Respiratory Medicine serves as a momentous validation of our translational science," stated Dr. Zaiqi Wang, Chairman and CEO of InxMed. He highlighted that this regimen could represent a paradigm shift for patients with KRAS G12C-mutated NSCLC.

KRAS G12C mutations are found in approximately 12–14% of NSCLC cases. While several KRAS G12C inhibitors exist for later lines of treatment, their use in the first-line setting has been hindered partly due to resistance. InxMed's research indicates that FAK inhibition by ifebemtinib can disrupt adaptive resistance pathways triggered by KRAS G12C inhibition.

Based on these promising data, ifebemtinib has received Breakthrough Therapy Designation from China's National Medical Products Administration for first-line NSCLC with KRAS G12C mutation. InxMed is advancing its clinical development, including an ongoing Phase III trial to potentially support the regimen as a new standard of care.