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在KRAS^G12C突变非小细胞肺癌中使用glecirasib:一个2b期试验

Yuankai Shi¹, Jian Fang², Ligang Xing³

¹Department of Medical Oncology, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China. syuankai@cicams.ac.cn.

Nature medicine

|January 6, 2025

概括

一种KRAS-G12C抑制剂Glecirasib在患有晚期非小细胞肺癌的患者中显示出47.9%的客观反应率. 治疗显示出有前途的疗效与可控的副作用.

科学领域:

在瘤学瘤学.
药理学药理学是指药理学的学科.
临床试验临床试验

背景情况:

非小细胞肺癌 (NSCLC) 经常携带KRAS突变,特别是KRAS-G12C.
针对性治疗对于改善晚期NSCLC的结果至关重要.
格莱西拉西布是一种试验中的共价口服KRAS-G12C抑制剂.

研究的目的:

评估glecirasib在患有局部晚期或转移KRAS G12C突变NSCLC的患者中的疗效和安全性.
确定客观响应率 (ORR) 作为主要终点.
评估与治疗相关的不良事件 (TRAEs).

主要方法:

一个多中心,单臂的2b期临床研究.
纳入了119名患有KRAS G12C突变NSCLC的患者.
格莱西拉西布每天服用800毫克口服,有效性由独立审查委员会 (IRC) 评估.

主要成果:

IRC评估的ORR为47.9% (56/117),其95%的置信区间为38.5-57.3%.
与治疗相关的不良事件 (TRAE) 在97.5%的患者中发生;3/4级TRAE在38.7%中观察到.
由于TRAE而停止治疗的比例为5.0%,没有与治疗相关的死亡.

结论:

格莱西拉西布在KRAS G12C突变NSCLC患者中显示出有前途的临床疗效.
在这个患者群体中,glecirasib的安全性概况是可以管理的.
对于先进的NSCLC治疗,需要对glecirasib进行进一步的研究.

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