#China #Nanjing #NSCLC #Ifebemtinib #Garsorasib

InxMed Breakthrough Publication in The Lancet Respiratory Medicine

InxMed Co., Ltd, a biotechnology company focused on innovative cancer therapies, has celebrated a significant milestone with the publication of clinical trial results of Ifebemtinib in combination with Garsorasib in the esteemed journal, The Lancet Respiratory Medicine. This study highlights a promising new approach for treating first-line non-small cell lung cancer (NSCLC) with the KRAS G12C mutation.

The Clinical Study Overview

The publication reports on a phase Ib/II clinical trial (NCT06166836/NCT05379946), analyzing the efficacy and safety of Ifebemtinib, a selective focal adhesion kinase (FAK) inhibitor, paired with Garsorasib, a potent KRASG12C inhibitor. Both medications offer a chemotherapy-free regimen designed to provide significant antitumor effects.

In the trial, 33 patients with first-line KRASG12C-mutant NSCLC were enrolled. Participants received oral doses of Ifebemtinib and Garsorasib for a median follow-up of 21.5 months. Notably, the results revealed these combinations resulted in high response rates – with a confirmed overall response rate (cORR) of 82%, and an astonishing 87% among evaluable patients. Tumor shrinkage was consistently noted, even among those with progressive disease.

Key Findings

The trial's promising findings included:

• - High Response Rates: Of 33 treated patients, 31 were found evaluable, presenting significantly encouraging results.
• - Durable Responses: Among responders, the median duration of response was not reached, indicating remarkable potential for delaying treatment resistance in patients.
• - Survival Benefits: The median progression-free survival (PFS) reached 22.3 months, revealing a significant impact on patient longevity with 12-month and 18-month PFS rates showing 67.9% and 58.2%, respectively.
• - Safety Profile: While all patients experienced treatment-emergent adverse effects, most were manageable and primarily of grade 1 or 2 severity.

Dr. Zaiqi Wang, Chairman and CEO of InxMed, remarked, "The publication of our long-term follow-up data serves as a vital affirmation of our translational science. Pairing the KRASG12C inhibitor with Ifebemtinib illustrates our success in obstructing adaptive resistance pathways, signifying a potential paradigm shift in treatment methodologies for these patients."

Addressing Resistance Mechanisms

KRASG12C mutations are present in approximately 12-14% of NSCLC cases. Until now, existing KRASG12C inhibitors were limited to use in previously-treated patients, often hindered by primary or developed resistance mechanisms. InxMed’s translational research indicates that sole KRASG12C inhibition instigates an adaptive hyperactivation of the FAK-YAP signaling pathway, contributing to tumor cell survival.

However, Ifebemtinib effectively disrupts this resistance, bringing tumor cells back into sensitivity towards KRASG12C inhibition, therefore extending response durations and treatment efficacy. This innovative coupling is paving the way for new therapeutic strategies aimed at targeting RAS mutations in cancer treatment.

Next Steps

Given the success of the clinical outcomes, Ifebemtinib has been awarded Breakthrough Therapy Designation from the China National Medical Products Administration for its use in first-line NSCLC. InxMed is gearing up for a randomized Phase III trial aimed at establishing this treatment regimen as a new standard of care.

Ifebemtinib not only demonstrates promise in the arena of KRASG12C but is also being studied across various RAS-mutant tumors, with ongoing developments exploring combinations with other RAS inhibitors and innovative drug classes.

About InxMed

Founded in 2017, InxMed seeks to revolutionize cancer therapy by tackling drug resistance through innovative treatments targeting the crucial signaling pathways involved in tumor growth and survival. By investing in translational medicine, InxMed is committed to changing treatment paradigms and improving outcomes for cancer patients globally. For further information, please visit their official website.