印度代购提示您，本品卡马替尼（Capmatinib,INC280）是一种是一种口服的高度选择性的Ia型MET抑制剂，也是FDA批准的首个针对METex14转移性NSCLC的靶向治疗药物（2020.5），获批的适应症为治疗携带MET外显子14跳跃突变的转移性NSCLC患者，包括一线治疗（初治）患者和先前接受过治疗（经治）的患者。

 Capmatinib (INC280) is an oral, highly selective type Ia MET inhibitor and the first FDA-approved targeted therapy for METex14 metastatic NSCLC (2020.5). The approved indication is for the treatment of patients with metastatic NSCLC who carry a jump mutation in MET exon 14, including first-line (untreated) patients and patients who have previously been treated (treated).

　　印度代购提示您，此次批准是基于II期的GEOMETRY mono-1研究结果。该研究是一项前瞻性，非随机，开放标签的II期研究，共招募94例携带MET外显子14跳跃突变的晚期或转移性NSCLC成人患者，经双盲独立审查委员会（BIRC）评估卡马替尼一线治疗的总缓解率为68%，先前接受过一种治疗方案的患者ORR为48％，先前经历过两种以上方案的METex14患者ORR为41％。中位反应持续时间分别为12.6个月和9.7个月。结果显示，无论患者既往是否接受过治疗（一线和后线），Capmatinib均能带来显著治疗效果。但是无进展生存（PFS）不是特别长，仅4个月左右，所以我们也期待该药后面更多的数据。

　　印度代购提示您，此外，卡马替尼还显示出很好的颅内反应。GEOMETRY mono-1试验中，有13位具有神经放射学数据的患者，有92％的患者合并颅内转移，54％的患者显示出很好的颅内反应（31%的患者显示出完全缓解）。在所有接受卡马替尼治疗的患者中，最常见的AE（任何原因；≥20％）为外周水肿，恶心，呕吐，血肌酐增加，呼吸困难，疲劳和食欲不振。

In addition, camatinib also shows a good intracranial response. The GEOMETRY Mono-1 trial included 13 patients with neuroradiological data, of whom 92% had intracranial metastasis and 54% showed good intracranial response (31% showed complete response). Among all patients treated with camatinib, AE (for any cause; ≥ 20%) peripheral edema, nausea, vomiting, increased serum creatinine, dyspnea, fatigue, and loss of appetite.