AENEAS: A Randomized Phase III Trial of Aumolertinib Versus Gefitinib as First-Line Therapy for Locally Advanced or MetastaticNon–Small-Cell Lung Cancer With EGFR Exon 19 Deletion or L858R Mutations

Aumolertinib (formerly almonertinib; HS-10296) is a novel third-generation epidermal growth factor receptor tyrosine kinase inhibitor approved in China. This double-blind phase III trial evaluated the efficacy and safety of aumolertinib compared with gefitinib as a first-line treatment for locally a...

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Detalles Bibliográficos
Autores principales: Lu, Shun, Dong, Xiaorong, Jian, Hong, Chen, Jianhua, Chen, Gongyan, Sun, Yuping, Ji, Yinghua, Wang, Ziping, Shi, Jianhua, Lu, Junguo, Chen, Shaoshui, Lv, Dongqing, Zhang, Guojun, Liu, Chunling, Li, Juan, Yu, Xinmin, Lin, Zhong, Yu, Zhuang, Wang, Zhehai, Cui, Jiuwei, Xu, Xingxiang, Fang, Jian, Feng, Jifeng, Xu, Zhi, Ma, Rui, Hu, Jie, Yang, Nong, Zhou, Xiangdong, Wu, Xiaohong, Hu, Chengping, Zhang, Zhihong, Lu, You, Hu, Yanping, Jiang, Liyan, Wang, Qiming, Guo, Renhua, Zhou, Jianying, Li, Baolan, Hu, Chunhong, Tong, Wancheng, Zhang, Helong, Ma, Lin, Chen, Yuan, Jie, Zhijun, Yao, Yu, Zhang, Longzhen, Jie, Weng, Li, Weidong, Xiong, Jianping, Ye, Xianwei, Duan, Jianchun, Yang, Haihua, Sun, Meili, Sun, Changan, Wei, Hongying, Li, Chuan, Ali, Siraj M., Miller, Vincent A., Wu, Qiong
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Wolters Kluwer Health 2022
Materias:
ORIGINAL REPORTS
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9509093/
https://www.ncbi.nlm.nih.gov/pubmed/35580297
http://dx.doi.org/10.1200/JCO.21.02641
Descripción
Sumario:Aumolertinib (formerly almonertinib; HS-10296) is a novel third-generation epidermal growth factor receptor tyrosine kinase inhibitor approved in China. This double-blind phase III trial evaluated the efficacy and safety of aumolertinib compared with gefitinib as a first-line treatment for locally advanced or metastatic EGFR-mutated non–small-cell lung cancer (NSCLC; ClinicalTrials.gov identifier: NCT03849768). METHODS: Patients at 53 sites in China were randomly assigned 1:1 to receive either aumolertinib (110 mg) or gefitinib (250 mg) once daily. The primary end point was progression-free survival (PFS) per investigator assessment. RESULTS: A total of 429 patients who were naïve to treatment for locally advanced or metastatic NSCLC were enrolled. PFS was significantly longer with aumolertinib compared with gefitinib (hazard ratio, 0.46; 95% CI, 0.36 to 0.60; P < .0001). The median PFS with aumolertinib was 19.3 months (95% CI, 17.8 to 20.8) versus 9.9 months with gefitinib (95% CI, 8.3 to 12.6). Objective response rate and disease control rate were similar in the aumolertinib and gefitinib groups (objective response rate, 73.8% and 72.1%, respectively; disease control rate, 93.0% and 96.7%, respectively). The median duration of response was 18.1 months (95% CI, 15.2 to not applicable) with aumolertinib versus 8.3 months (95% CI, 6.9 to 11.1) with gefitinib. Adverse events of grade ≥ 3 severity (any cause) were observed in 36.4% and 35.8% of patients in the aumolertinib and gefitinib groups, respectively. Rash and diarrhea (any grade) were observed in 23.4% and 16.4% of patients who received aumolertinib compared with 41.4% and 35.8% of those who received gefitinib, respectively. CONCLUSION: Aumolertinib is a well-tolerated third-generation epidermal growth factor receptor tyrosine kinase inhibitor that could serve as a treatment option for EGFR-mutant NSCLC in the first-line setting.

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