Glecirasib in KRAS-mutated Nonsmall-cell Lung Cancer: a Phase 2b Trial

Overview

Journal Nat Med

Specialties General Medicine
Molecular Biology

Date 2025 Jan 6

PMID 39762419

Authors

Yuankai Shi

Jian Fang

Ligang Xing

Yu Yao

Jian Zhang

Lian Liu

Yongsheng Wang

Changlu Hu

Jianping Xiong

Zhihua Liu

Runxiang Yang

Zhen Wang

Enfeng Zhao

Mengzhao Wang

Yanqiu Zhao

Kejing Tang

Zhihua Li

Zhengbo Song

Yongsheng Li

Wu Zhuang

Bo Jin

Ying Cheng

Yanping Hu

Yanhong Gu

Lin Wu

Rui Ma

Qitao Yu

Yan Yu

Jun Zhao

Hui Zhao

Dongqing Lv

Yanhong Shang

Puyuan Xing

Jin Zhou

Xingya Li

Zhe Liu

Zhaoxia Dai

Guohao Xia

Xueqin Chen

Yi Ba

Chunmei Bai

Qingshan Li

Guangyu An

Weiguo Hu

Yinxiang Wang

Andrea Wang-Gillam

Yuli Ding

Qiao Li

Zhiyue Rao

Affiliations

Soon will be listed here.

Abstract

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 .

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