机构:[1]Chinese Acad Med Sci & Peking Union Med Coll, Beijing Key Lab Clin Study Anticanc Mol Targeted D, Natl Canc Ctr, Natl Clin Res Ctr Canc,Canc Hosp,Dept Med Oncol, Beijing, Peoples R China[2]Beijing Canc Hosp, Beijing, Peoples R China[3]Shandong Canc Hosp, Jinan, Peoples R China[4]Xi An Jiao Tong Univ, Affiliated Hosp 1, Xian, Peoples R China[5]Fudan Univ, Shanghai Canc Ctr, Shanghai, Peoples R China[6]Shandong Univ, Dept Orthoped, Jinan, Peoples R China[7]Sichuan Univ, West China Hosp, Chengdu, Peoples R China四川大学华西医院[8]Anhui Prov Canc Hosp, Hefei, Peoples R China[9]Nanchang Univ, Affiliated Hosp 1, Nanchang, Peoples R China[10]Jiangxi Canc Hosp, Nanchang, Peoples R China[11]Yunnan Canc Hosp, Kunming, Peoples R China[12]Linyi Canc Hosp, Linyi, Peoples R China[13]Hebei Prov Cangzhou Hosp Integrated Tradit Chinese, Cangzhou, Peoples R China[14]Peking Union Med Coll Hosp, Beijing, Peoples R China[15]Henan Canc Hosp, Zhengzhou, Peoples R China河南省肿瘤医院[16]Sun Yat Sen Univ, Affiliated Hosp 1, Dept Rheumatol, Guangzhou, Peoples R China中山大学附属第一医院[17]Sun Yat Sen Univ, Sun Yat Sen Mem Hosp, Guangzhou, Peoples R China中山大学附属第二医院[18]Zhejiang Canc Hosp, Hangzhou, Peoples R China浙江省肿瘤医院[19]Chongqing Canc Hosp, Chongqing, Peoples R China[20]Fujian Canc Hosp, Fuzhou, Peoples R China[21]China Med Univ, Affiliated Hosp 1, Shenyang, Peoples R China[22]Jilin Canc Hosp, Changchun, Peoples R China[23]Hubei Canc Hosp, Wuhan, Peoples R China[24]Jiangsu Prov Hosp, Nanjing, Peoples R China江苏省人民医院[25]Hunan Canc Hosp, Changsha, Peoples R China[26]Liaoning Canc Hosp & Inst, Shenyang, Peoples R China[27]Guangxi Med Univ, Canc Hosp, Nanning, Peoples R China[28]Harbin Med Univ, Canc Hosp, Harbin, Peoples R China[29]Anhui Med Univ, Hosp 2, Hefei, Peoples R China[30]Taizhou Hosp Zhejiang Prov, Taizhou, Peoples R China台州恩泽医疗中心台州医院[31]Hebei Univ, Affiliated Hosp, Baoding, Peoples R China河北大学附属医院[32]Sichuan Canc Hosp, Chengdu, Peoples R China四川省肿瘤医院[33]Zhengzhou Univ, Affiliated Hosp 1, Zhengzhou, Peoples R China[34]Capital Med Univ, Affiliated Beijing Chest Hosp, Beijing, Peoples R China[35]Dalian Med Univ, Hosp 2, Dalian, Peoples R China[36]Jiangsu Canc Hosp, Nanjing, Peoples R China[37]Hangzhou Canc Hosp, Hangzhou, Peoples R China[38]Tianjin Med Univ Canc Inst & Hosp, Tianjin, Peoples R China[39]Chengde Med Univ, Dept Pathol, Chengde, Peoples R China[40]Capital Med Univ, Affiliated Beijing Chaoyang Hosp, Beijing, Peoples R China北京朝阳医院[41]Wuhan Univ, Renmin Hosp, Wuhan, Peoples R China[42]Jacobio Pharmaceut Co Ltd, Beijing, Peoples R China[43]Jacobio US Pharmaceut Inc, Burlington, MA USA
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 KRASG12C-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.
基金:
Jacobio (Beijing)
语种:
外文
WOS:
PubmedID:
中科院(CAS)分区:
出版当年[2025]版:
无
最新[2023]版:
大类|1 区医学
小类|1 区生化与分子生物学1 区细胞生物学1 区医学:研究与实验
JCR分区:
出版当年[2025]版:
无
最新[2023]版:
Q1BIOCHEMISTRY & MOLECULAR BIOLOGYQ1CELL BIOLOGYQ1MEDICINE, RESEARCH & EXPERIMENTAL
第一作者机构:[1]Chinese Acad Med Sci & Peking Union Med Coll, Beijing Key Lab Clin Study Anticanc Mol Targeted D, Natl Canc Ctr, Natl Clin Res Ctr Canc,Canc Hosp,Dept Med Oncol, Beijing, Peoples R China
通讯作者:
推荐引用方式(GB/T 7714):
Shi Yuankai,Fang Jian,Xing Ligang,et al.Glecirasib in KRASG12C-mutated nonsmall-cell lung cancer: a phase 2b trial[J].NATURE MEDICINE.2025,doi:10.1038/s41591-024-03401-z.
APA:
Shi, Yuankai,Fang, Jian,Xing, Ligang,Yao, Yu,Zhang, Jian...&Rao, Zhiyue.(2025).Glecirasib in KRASG12C-mutated nonsmall-cell lung cancer: a phase 2b trial.NATURE MEDICINE,,
MLA:
Shi, Yuankai,et al."Glecirasib in KRASG12C-mutated nonsmall-cell lung cancer: a phase 2b trial".NATURE MEDICINE .(2025)