InxMed Announces Positive Phase Ib/II Results for Ifebemtinib and Garsorasib in NSCLC with KRAS G12C Mutation

InxMed Co., Ltd, a biotechnology company focusing on innovative treatments for tumor resistance and metastasis, has revealed promising results from its Phase Ib/II clinical trial of ifebemtinib combined with garsorasib. This combination is being tested for the first-line treatment of non-small cell lung cancer (NSCLC) with KRAS G12C mutations. The announcement was made on May 30, 2024, and is set to be featured at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.

As of the cutoff date of May 10, 2024, 33 participants were enrolled in the study. Among the 31 evaluable subjects, significant antitumor responses were noted. The objective response rate (ORR) was 90.3%, and the disease control rate (DCR) stood at 96.8%. Among the participants, 28 experienced partial responses, and two had stable disease, with 26 of the partial responses confirmed at the time of reporting. Data on the median duration of response (DOR), progression-free survival (PFS), and overall survival (OS) are not yet fully mature.

The safety profile of the ifebemtinib and garsorasib combination was consistent with the monotherapy profiles of both drugs. Most adverse events were mild to moderate (Grade 1 or 2), although some Grade 3 adverse events were observed.

Dr. Zhengbo Song, Associate Professor at Zhejiang Cancer Hospital and Principal Investigator of the study, expressed optimism about the results. He highlighted that the combination therapy exceeded expectations and was well tolerated with known, manageable side effects. Dr. Song suggested that these findings warrant further exploration to assess the potential of ifebemtinib in improving the standard care for KRAS G12C mutant-driven NSCLC, potentially in conjunction with immunotherapies.

James McLeod, M.D., Chief Medical Officer of InxMed, also expressed enthusiasm about the findings. He noted that KRAS mutations are a significant concern, affecting approximately 30% of all cancer patients. The encouraging results from this study suggest that ifebemtinib could play a crucial role in combination therapies, enhancing clinical responses and safety profiles. Dr. McLeod emphasized the importance of understanding FAK’s role in tumor defense and how ifebemtinib could significantly boost the efficacy of KRAS inhibitors. He also mentioned that while current data on PFS and DOR are still incomplete, the initial findings align with previous trials in other tumor types.

Ifebemtinib, also known as IN10018 or BI853520, is a selective, orally administered focal adhesion kinase inhibitor. It has shown significant synergies with various therapeutic modalities, including chemotherapy, targeted therapy, and immunotherapy. InxMed is currently conducting a registrational trial for ifebemtinib in platinum-resistant ovarian cancer in China and multiple proof-of-concept trials in lung, colorectal, melanoma, and pancreatic cancers. Over 600 patients have been treated with ifebemtinib, demonstrating a favorable safety and tolerability profile.

Ifebemtinib has received Breakthrough Therapy Designation from China's National Medical Products Administration (NMPA) and Fast-Track designation from the U.S. Food and Drug Administration (FDA). InxMed plans to submit a New Drug Application to the NMPA in early 2025.

InxMed Co., Ltd, founded in 2018, is a clinical-stage biotechnology company dedicated to developing innovative therapies targeting tumor resistance and metastasis. The company’s pipeline includes several compounds aimed at various tumor defense mechanisms, offering highly differentiated therapeutic candidates.

The promising results from the ifebemtinib and garsorasib combination therapy trial mark a significant step forward in the treatment of KRAS G12C mutant-driven NSCLC, potentially setting the stage for new standards in cancer treatment.