InxMed FAK Inhibitor Ifebemtinib Received Breakthrough Therapy Designation by China National Medical Products Administration for First-Line Non-Small Cell Lung Cancer (NSCLC) With KRAS G12C Mutation
InxMed FAK Inhibitor Ifebemtinib Received Breakthrough Therapy Designation by China National Medical Products Administration for First-Line Non-Small Cell Lung Cancer (NSCLC) With KRAS G12C Mutation
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.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).
中国南京，2024年11月21日 /PRNewswire/ — 开发抗癌治疗耐药性和转移创新疗法的临床阶段生物技术公司InxMed有限公司宣布，中国国家药品监督管理局（NMPA）已授予伊贝替尼（IN10018）突破性疗法（BTD），用于使用KRAS对非小细胞肺癌（NSCLC）进行一线（1L）治疗 G12C 突变与 KRAS G12C 突变的特异抑制剂 garsorasib 联合使用。这是依贝替尼收到的第二个 BTD。2022年4月，依贝替尼获得了其首个与聚乙二醇脂质体多柔比星（PLD）联合治疗铂耐药卵巢癌（PROC）的BTD。
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.
Ifebemtinib 是一种针对局灶粘附激酶的高选择性口服给药小分子抑制剂，它与靶向疗法、免疫疗法和标准化疗显示出显著的临床协同作用。
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.
BTD得到了Ib/II期研究数据的支持，该研究评估了依贝替尼与加索拉西布联合用于1L治疗具有KRAS G12C突变的非小细胞肺癌（NCT06166836）的疗效和安全性。该临床试验的结果已在2024年美国临床肿瘤学会（ASCO）年会上公布。该双口服方案在1L KRASG12C NSCLC中显示出良好的抗肿瘤疗效和良好的耐受性。客观反应率（ORR）为90.3％，疾病控制率（DCR）为96.8％。从31名疗效可评估的患者中共报告了28例已确认的部分反应（PR）和两种稳定性疾病（SD）。到目前为止，所有接受治疗的患者都进行了9个月的随访就诊，在本报告发布时，尚未达到PFS中位数。
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.
除KRAS G12C抑制剂外，Ifebemtinib与多种标准和新兴的癌症疗法（例如抗PD-（L）1抗体、其他RAS靶向抑制剂、表皮生长因子抑制剂和ADC）联合使用时，还显示出显著的治疗协同作用。InxMed正在积极寻求与全球创新合作伙伴的合作。
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.
InxMed目前正在中国进行一项针对铂耐药卵巢癌的注册试验，该公司计划在2025年向国家药监局提交新药申请。InxMed还正在进行多项针对肺癌、结直肠癌、黑色素瘤和胰腺癌的概念验证试验，其中一些将进入关键研究。到目前为止，已有600多名受试者接受了ifebemtinib的治疗，并且已经观察到良好的安全性和耐受性。
About InxMed
关于 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.
InxMed Co.Ltd 是一家临床阶段的生物技术公司，开发针对肿瘤治疗耐药性和转移的创新疗法。InxMed成立于2018年，在对疾病生物学的深入理解的推动下，为临床转化研究建立了高效的引擎。InxMed的产品线包括几种靶向肿瘤防御机制的化合物，具有高度差异化的候选疗法。欲了解更多信息，请访问 en.inxmed.com。
SOURCE InxMed (Shanghai) Co., Ltd.
来源 InxMed（上海）有限公司
