InxMed's Ifebemtinib Gains Breakthrough Therapy Status for KRAS G12C NSCLC in China
Friday, November 22, 2024
InxMed has announced that its focal adhesion kinase (FAK) inhibitor, Ifebemtinib (IN10018), has received Breakthrough Therapy Designation (BTD) from China’s National Medical Products Administration (NMPA).
Non-Small Cell Lung Cancer (NSCLC) is the most common type of lung cancer, accounting for about 85% of cases. It includes subtypes like adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. NSCLC is often driven by specific genetic mutations, such as KRAS G12C, which impact tumour growth. Advances in targeted therapies, immunotherapies, and combination treatments have improved outcomes, especially for patients with these mutations.
This designation applies to the first-line treatment of non-small cell lung cancer (NSCLC) with the KRAS G12C mutation, in combination with garsorasib, a targeted KRAS G12C inhibitor.
This is the second BTD for Ifebemtinib, following a prior designation in April 2022 for the treatment of platinum-resistant ovarian cancer (PROC) when combined with PEG-liposomal doxorubicin (PLD).
Ifebemtinib is an orally administered, highly selective small molecule FAK inhibitor. It has shown potential to enhance the effectiveness of targeted therapies, immunotherapies, and chemotherapy.
The latest BTD was supported by data from a Phase Ib/II clinical study evaluating Ifebemtinib and garsorasib as a dual-oral regimen for first-line KRAS G12C NSCLC (NCT06166836). The study 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%.
Out of 31 evaluable patients, 28 achieved partial responses, and two had stable disease. At the time of reporting, all participants had been followed for nine months, and the median progression-free survival (PFS) had not yet been reached.
Ifebemtinib has also shown promising results when combined with other cancer treatments, including anti-PD-(L)1 antibodies, RAS-targeted inhibitors, EGFR inhibitors, and antibody-drug conjugates. InxMed is exploring global partnerships to further expand these applications.
The company is conducting a registrational trial for platinum-resistant ovarian cancer in China, with plans to submit a New Drug Application (NDA) in 2025.
Additionally, InxMed is running proof-of-concept studies in lung, colorectal, melanoma, and pancreatic cancers, with some trials expected to advance to pivotal stages. Over 600 patients have been treated with Ifebemtinib to date, with consistent evidence of safety and tolerability.
This milestone highlights InxMed's ongoing commitment to innovative cancer therapies that address unmet medical needs.
Source: prnewswire.com
