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维布列提尼布治疗高级非小细胞肺癌携带c-Met Exon 14跳转突变:一个多中心,单臂,第二阶段KUNPENG研究

Jin-Ji Yang¹, Yan Zhang^2,3, Lin Wu⁴

¹Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Southern Medical University, Guangzhou, China.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology

|July 26, 2024

概括

韦布列提尼布在治疗MET变异的非小细胞肺癌 (NSCLC) 中表现出显著的疗效. 这种MET抑制剂在KUNPENG试验中显示出高客观反应率和良好的安全性.

科学领域:

在瘤学瘤学.
药理学药理学是指药理学的学科.
遗传学遗传学是一个

背景情况:

非小细胞肺癌 (NSCLC) 仍然是全球癌症死亡的主要原因.
在MET信号通路的改变,特别是MET外显子14跳转 (METex14),是NSCLC患者的一个子集的关键瘤驱动因素.
抑制MET的向治疗对于改善这些患者的治疗结果至关重要.

研究的目的:

评估选择性MET抑制剂vebreltinib在患有局部晚期或转移性NSCLC携带MET变化的患者中的疗效和安全性.
评估客观响应率 (ORR) 和响应持续时间 (DoR) 作为主要和关键次要终点.

主要方法:

一个多中心,单臂,II期试验 (KUNPENG研究) 招募了患有c-Met失调的NSCLC的患者.
第1队列的重点是METex14突变NSCLC患者,这些患者从未接受过MET抑制剂的治疗.
患者每天两次服用维布雷尔提尼布200毫克;结果由独立审查委员会根据RECIST v1.1.1.评估.

主要成果:

这项研究招募了52名患者,其中35人 (67.3%) 尚未接受过治疗.
观察到75%的整体客观反应率 (ORR) (77.1%在未经治疗的群体中,70.6%在先前治疗的群体中).
中位数DoR为15.9个月,中位数无进展生存时间为14.1个月,中位数整体生存时间为20.7个月. 常见的不良事件包括外周胀和QT延长.

结论:

韦布列提尼布在患有METex14突变NSCLC的患者中表现出有希望的疗效.
该药物表现出良好的安全性,支持其作为治疗选择的潜力.
这些发现凸显了针对NSCLC中MET变化的治疗潜力.

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