Glecirasib用于KRAS突变的非小细胞肺癌：一项2b期试验。
Glecirasib in KRAS-mutated nonsmall-cell lung cancer: a phase 2b trial.
作者信息
Shi Yuankai, Fang Jian, Xing Ligang, Yao Yu, Zhang Jian, Liu Lian, Wang Yongsheng, Hu Changlu, Xiong Jianping, Liu Zhihua, Yang Runxiang, Wang Zhen, Zhao Enfeng, Wang Mengzhao, Zhao Yanqiu, Tang Kejing, Li Zhihua, Song Zhengbo, Li Yongsheng, Zhuang Wu, Jin Bo, Cheng Ying, Hu Yanping, Gu Yanhong, Wu Lin, Ma Rui, Yu Qitao, Yu Yan, Zhao Jun, Zhao Hui, Lv Dongqing, Shang Yanhong, Xing Puyuan, Zhou Jin, Li Xingya, Liu Zhe, Dai Zhaoxia, Xia Guohao, Chen Xueqin, Ba Yi, Bai Chunmei, Li Qingshan, An Guangyu, Hu Weiguo, Wang Yinxiang, Wang-Gillam Andrea, Ding Yuli, Li Qiao, Rao Zhiyue
机构信息
Department 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.
Beijing Cancer Hospital, Beijing, China.
出版信息
Nat Med. 2025 Mar;31(3):894-900. doi: 10.1038/s41591-024-03401-z. Epub 2025 Jan 6.
Glecirasib (JAB-21822) is a new covalent oral KRAS-G12C inhibitor. This multicenter, single-arm phase 2b study assessed the efficacy and safety of glecirasib administered orally at 800 mg daily in patients with locally advanced or metastatic KRAS-mutated nonsmall-cell lung cancer. The primary endpoint was the objective response rate (ORR) assessed by an independent review committee (IRC). Between 15 September 2022 and 28 September 2023, 119 patients with a median age of 62 years were enrolled. As of the data cut-off date on 28 March 2024, the ORR assessed by IRC was 47.9% (56/117; 95% confidence interval: 38.5-57.3%). The incidence of treatment-related adverse events (TRAEs) of any grade was 97.5% (116/119). The incidence of grades 3 and 4 TRAEs was 38.7% (46/119). A total of 5.0% (6/119) of patients discontinued the treatment due to TRAEs. No treatment-related deaths occurred. Glecirasib exhibited promising clinical efficacy and manageable safety profiles in these patient populations. ClinicalTrials.gov identifier: NCT05009329 .
格来西拉西布（JAB - 21822）是一种新型的共价口服KRAS - G12C抑制剂。这项多中心、单臂2b期研究评估了每日口服800毫克格来西拉西布对局部晚期或转移性KRAS突变非小细胞肺癌患者的疗效和安全性。主要终点是由独立审查委员会（IRC）评估的客观缓解率（ORR）。在2022年9月15日至2023年9月28日期间，纳入了119例患者，中位年龄为62岁。截至2024年3月28日的数据截止日期，IRC评估的ORR为47.9%（56/117；95%置信区间：38.5 - 57.3%）。任何级别的治疗相关不良事件（TRAEs）发生率为97.5%（116/119）。3级和4级TRAEs的发生率为38.7%（46/119）。共有5.0%（6/119）的患者因TRAEs停止治疗。未发生与治疗相关的死亡。格来西拉西布在这些患者群体中显示出有前景的临床疗效和可控的安全性。ClinicalTrials.gov标识符：NCT05009329 。
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