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).
中國南京，2024年11月21日 /PRNewswire/ -- InxMed有限公司是一家臨床階段的生物技術公司，致力於開發針對癌症治療耐藥性和轉移的新型療法。公司宣佈，中國國家藥品監督管理局（NMPA）已授予Ifebemtinib（IN10018）首要治療指定（BTD），用於第一線（1L）治療具有KRAS G12C突變的非小細胞肺癌（NSCLC），與針對KRAS G12C突變的特定抑制劑garsorasib聯合使用。這是ifebemtinib獲得的第二個BTD。2022年4月，ifebemtinib獲得了其第一個BTD，用於聯合使用PEG-脂質體多柔比星（PLD）治療鉑耐藥性卵巢癌（PROC）。
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是一種高度選擇性的口服小分子抑制劑，針對焦點粘附激酶，已顯示出與靶向療法、免疫療法和標準化學治療的顯著臨床協同作用。
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得到了來自評估ifebemtinib與garsorasib聯合用於1L治療KRAS G12C突變的NSCLC的Ib/II期研究的數據支持（NCT06166836）。臨床試驗的結果在2024年美國臨床腫瘤學會（ASCO）年會上進行了特色展示。雙口服方案在1L KRASG12C NSCLC中顯示出良好的抗腫瘤療效和耐受性良好的安全性。客觀緩解率（ORR）爲90.3%，疾病控制率（DCR）爲96.8%。在31例評估效能的患者中，共報告了28例確認的部分緩解（PR）和2例穩定疾病（SD）。所有接受治療的患者的隨訪訪問至今已達到9個月，而在本報告時，中位無進展生存期（PFS）尚未達到。
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.
除了KRAS G12C抑制劑外，Ifebemtinib在與廣泛的標準及新興癌症治療聯用時也展示了顯著的治療協同作用，例如抗PD-(L)1抗體、其他RAS靶向抑制劑、EGFR抑制劑和ADC。InxMed正在全球範圍內積極尋求與創新夥伴的合作。
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目前正在中國進行一種鉑金耐藥卵巢癌的註冊試驗，公司計劃在2025年向NMPA提交新藥申請。InxMed還在進行多項證據概念試驗，涉及肺癌、結直腸癌、黑色素瘤和胰腺癌，其中一些試驗將進入關鍵研究。目前，已有超過600名受試者接受了ifebemtinib治療，並觀察到良好的安全性和耐受性。
About InxMed
關於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有限公司是一家臨床階段的生物技術公司，專注於開發對抗腫瘤治療耐藥性和轉移的創新療法。InxMed成立於2018年，建立了一套高效的臨床轉化研究引擎，基於對疾病生物學的深入理解。InxMed的產品管線包括若干針對腫瘤防禦機制的化合物，具有高度差異化的治療候選者。欲獲取更多信息，請訪問en.inxmed.com。
SOURCE InxMed (Shanghai) Co., Ltd.
來源 InxMed（上海）有限公司。
