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Efficacy of Aumolertinib (HS-10296) in Patients with Advanced EGFR T790M+ NSCLC: Updated Post NMPA-approval Results from the APOLLO Registrational Trial.

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作者：
Shun Lu[1,*1] * ; Qiming Wang[2] ; Guojun Zhang[3] ; Xiaorong Dong[5] ; Cheng-Ta Yang[5] ; Yong Song[6] ; Gee-Chen Chang[7] ; You Lu[8] ; Hongming Pan[9] ; Chao-Hua Chiu[10] ; Zhehai Wang[11] ; Jifeng Feng[12] ; Jianying Zhou[13] ; Xingxiang Xu[14] ; Renhua Guo[15] ; Jianhua Chen[16] ; Haihua Yang[17] ; Yuan Chen[18] ; Zhuang Yu[19] ; Her-Shyong Shiah[20] ; Chin-Chou Wang[21] ; Nong Yang[22] ; Jian Fang[23] ; Ping Wang[24] ; Kai Wang[25] ; Yanping Hu[26] ; Jianxing He[27] ; Ziping Wang[23] ; Jianhua Shi[28] ; Shaoshui Chen[29] ; Qiong Wu[30] ; Changan Sun[31] ; Chuan Li[30] ; Hongying Wei[30] ; Ying Cheng[32] ; Wu-Chou Su[33] ; Te-Chun Hsia[34] ; Jiuwei Cui[35] ; Yuping Sun[36] ; Sai-Hong Ignatius Ou[37] ; Viola W. Zhu[37] ; James Chih-Hsin Yang[38] ;
机构： [1]Department of Medical Oncology, Shanghai Chest Hospital,Shanghai JiaoTong University, Shanghai, China [2]Department of Internal Medicine, Henan Cancer Hospital Affiliated to Zhengzhou University,Zhengzhou, China [3]Department of Respiration, The First Affiliated Hospital ofZhengzhou University, Zhengzhou, China [4]Cancer Center, Union Hospital Tongji Medical College Huazhong University of Science and Technology,Wuhan, China [5]Department of Thoracic Medicine, Linkou Chang Gung Memorial Hospital, Taoyuan, [6]Department of Respiration, General Hospital of The PLA Eastern Theater Command, Nanjing,China [7]Division of Chest Medicine, Department of Internal Medicine, TaichungVeterans General Hospital, Taichung, Taiwan, Republic of China [8]Department of Thoracic Oncology, West China Hospital of Sichuan University, Chengdu,China [9]Department of Oncology, Sir Run Shaw Hospital, School of Medicine,Zhejiang University, Hangzhou, China [10]Division of Thoracic Oncology, Department of Chest Medicine, Taipei Veterans General Hospital, Taipei,Taiwan, Republic of China [11]Department of Oncology, Shandong CancerHospital, Jinan, China [12]Department of Internal Medicine, Jiangsu Cancer Hospital, Jiangsu Institute of Cancer Research, The Affiliated Cancer Hospitalof Nanjing Medical University, Nanjing, China [13]Department of Respiratory Medicine, The First Affiliated Hospital, Zhejiang University School of Medicine,Hangzhou, China [14]Department of Respiration, Northern Jiangsu People's Hospital, The Affiliated Hospital to Yangzhou University, Yangzhou, China [15]Department of Medical Oncology, Jiangsu Province Hospital, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China [16]Department of Medical Oncology-Chest, Hunan Cancer Hospital & The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha,China [17]Department of Radiotherapy, Taizhou Hospital of Zhejiang Province,Taizhou, China [18]Department of Oncology, Tongji Medical College Huazhong University of Science & Technology, Wuhan, China [19]Department of Oncology,The Affiliated Hospital of Qingdao University, Qingdao, China [20]Graduate Institute of Cancer Biology and Drug Discovery, College of Medical Science and Technology, Taipei Medical University, Taipei, Taiwan, Republic of China [21]Department of Occupational Medicine, Kaohsiung Chang Gung MemorialHospital, Kaohsiung, Taiwan, Republic of China [22]Department of Pulmonary Gastroenterology, Hunan Cancer Hospital & The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China [23]Department of Chest Medicine, Beijing Cancer Hospital, Beijing, China [24]Department of Radiotherapy, Tianjin Medical University Cancer Institute &Hospital, Tianjin, China [25]Department of Respiration, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China [26]Department of Thoracic Oncology, Hubei Cancer Hospital, Wuhan [27]Department of Thoracic Surgery, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China [28]Department of Internal Medicine,Linyi Cancer Hospital, Linyi, China [29]Department of Oncology, BinzhouMedical University Hospital, Binzhou, China [30]Clinical Medical Group,Jiangsu Hansoh Pharmaceutical Group Co.L.td.,Shanghai, China [31]Clinical Operation Group, Jiangsu Hansoh Pharmaceutical Group Co.L.td.,Shanghai, China [32]Department of Internal Medicine, Jilin Cancer Hospital,Changchun, China [33]Division of Hematology/Oncology, Department of Internal Medicine, National Cheng Kung University Hospital, Taipei, Taiwan,Republic of China [34]Division of Pulmonary and Critical Care Medicine, China Medical University Hospital, Taichung, Taiwan, Republic of China [35]Department of Oncology, The First Bethune Hospital of Jilin University,Changchun, China [36]Department of Oncology, Jinan Central Hospital, Jinan,China [37]Chao Family Comprehensive Cancer Center, Department of Medicine, Division of Hematology/Oncology, University of California, Irvine School ofMedicine, Orange, CA, USA [38]Department of Oncology, National Taiwan University Hospital, Taipei, Taiwan, Republic of China
出处：
DOI： 10.1016/j.jtho.2021.10.024
ISSN：

关键词： aumolertinib almonertinib HS-10296 EGFR T790M mutation third-generation EGFR TKI

摘要：
Aumolertinib (formerly almonertinib; HS-10296) is a novel third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) with demonstrated activity against EGFR sensitizing mutations and EGFR T790M mutation.Patients with locally advanced or Metastatic non-small cell lung cancer (NSCLC) who developed an EGFR T790M mutation after progression on first- or second-generation EGFR TKI therapy were enrolled into this registrational phase 2 trial of aumolertinib at 110 mg orally once daily (NCT02981108). The primary endpoint was objective response rate (ORR) by independent central review (ICR).A total of 244 patients with EGFR T790M-positive NSCLC were enrolled. The ORR by ICR was 68.9% (95% CI: 62.6-74.6). The disease control rate (DCR) was 93.4% (95% CI: 89.6-96.2). The median duration of response (DOR) was 15.1 months (95% CI: 12.5-16.6). The median progression-free survival was12.4 months (95% CI: 9.7-15.0). Among 23 patients with evaluable central nervous system (CNS) metastases, the CNS-ORR and CNS-DCR were 60.9% (95% CI: 38.5-80.3) and 91.3% (95% CI: 72.0-98.9), respectively. The median CNS-DOR was 12.5 months (95% CI: 5.6-NR). Treatment-related adverse events of ≥ grade 3 occurred in 16.4% of patients, with the most common being blood creatine phosphokinase increased (7%) and alanine aminotransferase increased (1.2%). The relative dose density of aumolertinib was 99.2% in this study.Aumolertinib is an effective and well-tolerated third-generation EGFR TKI for patients with EGFR T790M-positive advanced NSCLC after disease progression on first- and second-generation EGFR TKI therapy. Based on these findings, aumolertinib was approved in China for EGFR T790M-positive patients.Copyright © 2021 International Association for the Study of Lung Cancer. Published by Elsevier Inc. All rights reserved.

基金：
This work was supported by Hansoh Pharmaceutical Group Co. Ltd., The National Key R&D Program of China (2016YFC1303300), and Shanghai Science and Technology Innovation Program (19411950500).
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外文
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出版当年[2022]版：
大类 | 1 区 医学
小类 | 1 区 肿瘤学 1 区 呼吸系统
最新[2023]版：
大类 | 1 区 医学
小类 | 1 区 肿瘤学 1 区 呼吸系统
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出版当年[2022]版：
Q1 ONCOLOGY Q1 RESPIRATORY SYSTEM
最新[2023]版：
Q1 ONCOLOGY Q1 RESPIRATORY SYSTEM

影响因子： 最新[2023版] 最新五年平均 出版当年[2022版] 出版当年五年平均 出版前一年[2021版] 出版后一年[2023版]

第一作者：
第一作者机构： [1]Department of Medical Oncology, Shanghai Chest Hospital,Shanghai JiaoTong University, Shanghai, China [*1]Department of Medical Oncology,74 Shanghai Chest Hospital, Shanghai JiaoTong University, Shanghai,200030, China.
通讯作者：
通讯机构： [1]Department of Medical Oncology, Shanghai Chest Hospital,Shanghai JiaoTong University, Shanghai, China [*1]Department of Medical Oncology,74 Shanghai Chest Hospital, Shanghai JiaoTong University, Shanghai,200030, China.
推荐引用方式(GB/T 7714)：
Shun Lu,Qiming Wang,Guojun Zhang,et al.Efficacy of Aumolertinib (HS-10296) in Patients with Advanced EGFR T790M+ NSCLC: Updated Post NMPA-approval Results from the APOLLO Registrational Trial.[J].JOURNAL OF THORACIC ONCOLOGY.2022,17(3):411-422.doi:10.1016/j.jtho.2021.10.024.
APA：
Shun Lu,Qiming Wang,Guojun Zhang,Xiaorong Dong,Cheng-Ta Yang...&James Chih-Hsin Yang.(2022).Efficacy of Aumolertinib (HS-10296) in Patients with Advanced EGFR T790M+ NSCLC: Updated Post NMPA-approval Results from the APOLLO Registrational Trial..JOURNAL OF THORACIC ONCOLOGY,17,(3)
MLA：
Shun Lu,et al."Efficacy of Aumolertinib (HS-10296) in Patients with Advanced EGFR T790M+ NSCLC: Updated Post NMPA-approval Results from the APOLLO Registrational Trial.".JOURNAL OF THORACIC ONCOLOGY 17..3(2022):411-422

相关文献

[1]Safety, Efficacy and Pharmacokinetics of Almonertinib (HS-10296) in Pretreated Patients with EGFR-mutated Advanced NSCLC: a Multicenter, Open-label, Phase I Trial. [2]Central nervous system efficacy of aumolertinib versus gefitinib in patients with untreated, EGFR-mutated, advanced non-small cell lung cancer: data from a randomized phase III trial (AENEAS) [3]Efficacy and safety of aumolertinib combined with or without chemotherapy as an adjuvant treatment for stage II-IIIA non-small cell lung cancer following complete tumour resection: The first third-generation EGFR-TKI versus chemotherapy phase III clinical study (APEX) [4]Development and validation of a UPLC-MS/MS method for quantification of C-005, a novel third-generation EGFR TKI, and its major metabolite in plasma: Application to its first-in-patient study. [5]EGFR T790M ctDNA testing platforms and their role as companion diagnostics: Correlation with clinical outcomes to EGFR-TKIs [6]Efficacy of Aumolertinib (HS-10296) in Patients With Advanced EGFR T790M+ NSCLC: Updated Post-National Medical Products Administration Approval Results From the APOLLO Registrational Trial. [7]Randomized phase III trial of aumolertinib (HS-10296, Au) versus gefitinib (G) as first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) and EGFR exon 19 del or L858R mutations (EGFRm) [8]Real-world efficacy of osimertinib in previously EGFR-TKI treated NSCLC patients without identification of T790M mutation. [9]EGFR T790M ctDNA testing platforms and their role as companion diagnostics: Correlation with clinical outcomes to EGFR-TKIs [10]Discovery and structural optimization of potent epidermal growth factor receptor (EGFR) inhibitors against L858R/T790M/C797S resistance mutation for lung cancer treatment.

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