#China #Nanjing #Cancer Treatment #KRAS G12C #Ifebemtinib

InxMed's Innovative Cancer Treatment Approach

InxMed Co., Ltd, a pioneering clinical-stage biotechnology firm, has recently showcased compelling clinical trial data for its innovative cancer therapy combining the oral focal adhesion kinase (FAK) inhibitor Ifebemtinib (IN10018) with the KRAS G12C inhibitor, garsorasib (D-1533). This data was presented during the 2025 Annual Meeting of the American Society of Clinical Oncology (ASCO) and indicates potential improvements in treating KRAS G12C-mutant solid tumors, a challenging classification known for limited treatment options.

Overview of the Clinical Data

The Phase Ib/II clinical trial, registered under NCT06166836 and NCT05379946, evaluated the safety and efficacy of the Ifebemtinib and garsorasib combination in patients with specific types of cancers, including non-small cell lung cancer (NSCLC) and colorectal cancer (CRC). The results are noteworthy, reflecting substantial response rates and durability of treatment effects.

Key Findings from the NSCLC Cohort

The data from 33 first-line NSCLC patients indicated impressive results, which reflect a median progression-free survival (mPFS) of 22.3 months and a median duration of response (mDOR) of 19.4 months. Previously reported objective response rates (ORR) soared to 90.3%, reinforcing the regimen's potential effectiveness regardless of the PD-L1 expression status. Notably, the median overall survival (mOS) has yet to be determined, but the survival curve demonstrates promising upward trends suggesting long-term benefits.

Insights from the CRC Randomized Study

In a parallel randomized trial involving 36 CRC patients who had undergone previous treatments, those receiving Ifebemtinib combined with garsorasib exhibited a 44.4% ORR compared to 16.7% in the sole garsorasib group. Additionally, the disease control rate (DCR) was notably higher at 100%, with a mPFS of 7.7 months, showcasing the advantages of this combination therapy for previously treated patients.

Expert Commentary

Dr. Zaiqi Wang, CEO of InxMed, expressed excitement about the findings, stating: “These results validate Ifebemtinib as an ideal combination partner for RAS inhibitors in RAS-driven malignancies to boost efficacy significantly.” He emphasized that the significant efficacy and favorable safety profile pave the way for a chemotherapy-free regimen, potentially redefining treatment strategies for KRAS G12C-mutant cancers.

Future Directions

Building on these exciting results, InxMed is poised to initiate a pivotal Phase III trial evaluating the regimen for first-line KRAS G12C-mutant NSCLC patients. Additionally, they are exploring further combinations of Ifebemtinib with other KRAS-targeted therapies, including investigational RAS inhibitors.

About Ifebemtinib

Ifebemtinib is distinguished by its selectivity and oral administration, aiming to disrupt critical tumor defenses mediated by FAK signaling pathways. The favorable safety profile and clinical synergy with established therapies make it a promising candidate for inclusion in treatment paradigms addressing cancer resistance and metastasis.

Conclusion

As InxMed continues its commitment to revolutionize cancer treatment, the promising results from the ongoing clinical trials signal a potential significant breakthrough for patients grappling with KRAS G12C mutations. These developments herald a new era in targeted cancer therapies and underscore the importance of innovative combinations in the fight against cancer.