NANJING, China, Nov. 21, 2024 /PRNewswire/ -- InxMed Co., Ltd, a clinical-stage biotechnology company developing innovative therapies against cancer treatment resistance and metastasis, announced that China National Medical Products Administration (NMPA) has granted Ifebemtinib (IN10018) Breakthrough Therapy designation (BTD) for the first-line (1L) treatment of non-small cell lung cancer (NSCLC) with KRAS G12C mutation in combination with garsorasib, a specific inhibitor of the KRAS G12C mutation. This is the second BTD ifebemtinib received. In April 2022, ifebemtinib was granted its first BTD for the treatment of platinum-resistant ovarian cancer (PROC) in combination with PEG-liposomal doxorubicin (PLD).
Ifebemtinib is a highly selective, orally administered, small molecule inhibitor for focal adhesion kinase, which has demonstrated significant clinical synergies with targeted therapies, immunotherapies, and standard chemotherapies.
The BTD is supported by the data from the Phase Ib/II study evaluating the efficacy and safety of ifebemtinib in combination with garsorasib for the 1L treatment of NSCLC with KRAS G12C mutation (NCT06166836). The results of the clinical trial were featured at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. The dual-oral regimen showed promising antitumor efficacy with a well-tolerated safety profile in 1L KRASG12C NSCLC. The objective response rate (ORR) was 90.3% and the disease control rate (DCR) was 96.8%. A total of 28 confirmed partial responses (PRs) and two stable diseases (SDs) were reported from 31 efficacy evaluable patients. All treated patients have achieved a follow-up visit of 9 months so far, and the median PFS has not been reached at the time of this report.
Beyond KRAS G12C inhibitors, Ifebemtinib has also shown significant therapeutic synergies when combined with a wide range of standard and emerging cancer treatments, such as anti-PD-(L)1 antibodies, other RAS-targeted inhibitors, EGFR inhibitors, and ADCs. InxMed is actively pursuing collaborations with innovating partners globally。
InxMed is currently conducting a registrational trial in platinum-resistant ovarian cancer in China, for which the company plans to submit a New Drug Application to the NMPA in 2025. InxMed also has multiple proof-of-concept trials ongoing in lung, colorectal, melanoma, and pancreatic cancers, some of which will progress into pivotal studies. Thus far, more than 600 subjects have been treated with ifebemtinib, and a favorable safety and tolerability profile has been observed.
About InxMed
InxMed Co. Ltd is a clinical-stage biotech company developing innovative therapies against tumor treatment resistance and metastasis. Established in 2018, InxMed has built an efficient engine for clinical translational research driven by an in-depth understanding of disease biology. InxMed's pipeline includes several compounds targeting tumor defense mechanisms with highly differentiated therapeutic candidates. For more information, please visit en.inxmed.com.