InxMed's Ifebemtinib Receives Breakthrough Therapy Designation for NSCLC with KRAS G12C Mutation
核心洞察
InxMed (搜索)'s ifebemtinib has been granted Breakthrough Therapy Designation (BTD) by China's NMPA for first-line treatment of NSCLC (搜索) with KRAS G12C mutation (搜索).
The BTD is supported by Phase Ib/II study data, showcasing a 90.3% objective response rate and a 96.8% disease control rate when combined with garsorasib.
Ifebemtinib, a FAK (搜索) inhibitor, has shown synergies with targeted therapies and immunotherapies, with ongoing trials in multiple cancer types.
InxMed (搜索) Co. Ltd announced that its focal adhesion kinase (FAK (搜索)) inhibitor, ifebemtinib (IN10018), has received Breakthrough Therapy Designation (BTD) from the China National Medical Products Administration (NMPA) for the first-line treatment of non-small cell lung cancer (搜索) (NSCLC (搜索)) with KRAS G12C mutation (搜索), in combination with garsorasib. This marks the second BTD for ifebemtinib, the first being for platinum-resistant ovarian cancer (搜索) (PROC).
Promising Clinical Data in NSCLC
The BTD is based on data from a Phase Ib/II study (NCT06166836) evaluating ifebemtinib in combination with garsorasib for first-line NSCLC (搜索) with KRAS G12C mutation (搜索). The results, presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, demonstrated an objective response rate (ORR) of 90.3% and a disease control rate (DCR) of 96.8% in efficacy-evaluable patients (n=31). The study reported 28 confirmed partial responses (PRs) and two stable diseases (SDs). With a 9-month follow-up, the median PFS had not been reached at the time of the report.
Ifebemtinib: A FAK Inhibitor with Broad Potential
Ifebemtinib is a highly selective, orally administered small molecule inhibitor of focal adhesion kinase (FAK (搜索)). It has demonstrated clinical synergies with targeted therapies, immunotherapies, and standard chemotherapies. In addition to KRAS G12C inhibitors, ifebemtinib has shown therapeutic synergies with anti-PD-(L)1 antibodies, other RAS-targeted inhibitors, EGFR inhibitors, and antibody-drug conjugates (ADCs).
Ongoing Clinical Development
InxMed (搜索) is currently conducting a registrational trial in China for platinum-resistant ovarian cancer (搜索), with plans to submit a New Drug Application (NDA) to the NMPA in 2025. The company also has multiple proof-of-concept trials ongoing in lung, colorectal (搜索), melanoma (搜索), and pancreatic cancers (搜索), some of which will progress into pivotal studies. To date, over 600 subjects have been treated with ifebemtinib, showing a favorable safety and tolerability profile.