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)
Corresponding Author
Shun Lu
Department of Medical Oncology, Shanghai Chest Hospital Shanghai JiaoTong University, Shanghai, P. R. China
Correspondence
Shun Lu, MD PhD, Department of Medical Oncology, Shanghai Chest Hospital, Shanghai JiaoTong University, Shanghai, 200030, China.
Email: [email protected]
Search for more papers by this authorXiaorong Dong
Cancer Center, Union Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan, Hubei, P. R. China
Search for more papers by this authorHong Jian
Department of Medical Oncology, Shanghai Chest Hospital Shanghai JiaoTong University, Shanghai, P. R. China
Search for more papers by this authorJianhua Chen
Department of Medical Oncology-Chest, Hunan Cancer Hospital & The Affiliated Cancer Hospital of Central South University Xiangya School of Medicine, Changsha, Hunan, P. R. China
Search for more papers by this authorGongyan Chen
Thoracic Oncology Medicine, Harbin Medical University Cancer Hospital, Harbin, Heilongjiang, P. R. China
Search for more papers by this authorYuping Sun
Department of Oncology, Jinan Central Hospital, Jinan, Shandong, P. R. China
Search for more papers by this authorYinghua Ji
Department of Oncology, First Affiliated Hospital of Xinxiang Medical University, Xinxiang, Henan, P. R. China
Search for more papers by this authorZiping Wang
Department of Chest Medicine, Beijing Cancer Hospital, Beijing, P. R. China
Search for more papers by this authorJianhua Shi
Department of Internal Medicine, Linyi Cancer Hospital, Linyi, Shandong, P. R. China
Search for more papers by this authorJunguo Lu
Department of Respiratory Medicine, Nantong Tumor Hospital, Nantong, Jiangsu, P. R. China
Search for more papers by this authorShaoshui Chen
Department of Oncology, Binzhou Medical University Hospital, Binzhou, Shandong, P. R. China
Search for more papers by this authorDongqing Lv
Breath Internal Medicine, Taizhou Hospital of Zhejiang Province, Linhai, Zhejiang, P. R. China
Search for more papers by this authorGuojun Zhang
Department of Respiration, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, P. R. China
Search for more papers by this authorChunling Liu
Department of Lung Internal Medicine, Affiliated Tumor Hospital of Xinjiang Medical University, Urumqi, Xinjiang, P. R. China
Search for more papers by this authorJuan Li
Department of Thoracic Oncology, Sichuan Cancer Hospital, Chengdu, Sichuan, P. R. China
Search for more papers by this authorXinmin Yu
Thoracic Medical Oncology, Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Hangzhou, Zhejiang, P. R. China
Search for more papers by this authorZhong Lin
Department of Thoracic Oncology, The Fifth Subsidiary Sun Yat-sen University Hospital, Zhuhai, Guangdong, P. R. China
Search for more papers by this authorZhuang Yu
Department of Oncology, The Affiliated Hospital of Qingdao University, Qingdao, Shandong, P. R. China
Search for more papers by this authorZhehai Wang
Department of Oncology, Shandong Cancer Hospital, Jinan, Shandong, P. R. China
Search for more papers by this authorJiuwei Cui
Department of Oncology, The First Bethune Hospital of Jilin University, Changchun, Jilin, P. R. China
Search for more papers by this authorXingxiang Xu
Department of Respiration, Northern Jiangsu People's Hospital Affiliated to Yangzhou University, Yangzhou, Jiangsu, P. R. China
Search for more papers by this authorJian Fang
Department of Chest Medicine, Beijing Cancer Hospital, Beijing, P. R. China
Search for more papers by this authorJifeng Feng
Department of Internal Medicine, Jiangsu Cancer Hospital, Nanjing, Jiangsu, P. R. China
Search for more papers by this authorZhi Xu
Department of Respiration, The Second Affiliated Hospital of Army Medical University, Chongqing, P. R. China
Search for more papers by this authorRui Ma
Department of Chest Internal Medicine, Liaoning Cancer Hospital & Institute, Shenyang, Liaoning, P. R. China
Search for more papers by this authorJie Hu
Respiratory Medicine, Zhongshan Hospital Fudan University, Shanghai, P. R. China
Search for more papers by this authorNong Yang
Lung & Gastrointestinal Oncology Department, Hunan Cancer Hospital & The Affiliated Cancer Hospital of Central South University Xiangya School of Medicine, Changsha, Hunan, P. R. China
Search for more papers by this authorXiangdong Zhou
Department of Respiratory and Critical Care Medicine, The Southwest Hospital of AMU, Chongqing, P. R. China
Search for more papers by this authorXiaohong Wu
Department of Oncology, Affiliated Hospital of Jiangnan University, Wuxi, Jiangsu, P. R. China
Search for more papers by this authorChengping Hu
Respiratory Medicine, Xiangya Hospital Central South University, Changsha, Hunan, P. R. China
Search for more papers by this authorZhihong Zhang
Department of Respiration Oncology, Anhui Provincial Cancer Hospital, Hefei, Anhui, P. R. China
Search for more papers by this authorYou Lu
Department of Thoracic Oncology, West China Hospital of Sichuan University, Chengdu, Sichuan, P. R. China
Search for more papers by this authorYanping Hu
Department of Thoracic Oncology, Hubei Cancer Hospital, Wuhan, Hubei, P. R. China
Search for more papers by this authorLiyan Jiang
Department of Respiration, Shanghai Chest Hospital, Shanghai JiaoTong University, Shanghai, P. R. China
Search for more papers by this authorQiming wang
Department of Respiration, Henan Cancer hospital, Zhengzhou, Henan, P. R. China
Search for more papers by this authorRenhua Guo
Department of Oncology, Jiangsu Province Hospital, Nanjing, Jiangsu, P. R. China
Search for more papers by this authorJianying Zhou
Department of Respiratory Medicine, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, P. R. China
Search for more papers by this authorBaolan Li
Department of Oncology Internal Medicine, Beijing Chest Hospital, Capital Medical University, Beijing, P. R. China
Search for more papers by this authorChunhong Hu
Department of Oncology, Xiangya Second Hospital of Central South University, Changsha, Hunan, P. R. China
Search for more papers by this authorWancheng Tong
Department of Infection Internal Medicine, Nanfang Hospital, Nanfang Medical University, Guangzhou, Guangdong, P. R. China
Search for more papers by this authorHelong Zhang
Department of Oncology, The Second Affiliated Hospital of Air Force Military Medical University, Xi'an, Shanxi, P. R. China
Search for more papers by this authorLin Ma
Department of Respiration, The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, P. R. China
Search for more papers by this authorYuan Chen
Department of Oncology, Tongji Medical College Huazhong University of Science & Technology, Wuhan, Hubei, P. R. China
Search for more papers by this authorZhijun Jie
Department of Respiratory and Critical Care Medicine, Shanghai Fifth People's Hospital, Fudan University, Shanghai, P. R. China
Search for more papers by this authorYu Yao
Department of Oncology Internal Medicine, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shanxi, P. R. China
Search for more papers by this authorLongzhen Zhang
Radiotherapy Department, The Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu, P. R. China
Search for more papers by this authorJie Weng
Department of Oncology, Yueyang Central Hospital, Yueyang, Hunan, P. R. China
Search for more papers by this authorWeidong Li
Department of Internal Medicine, Affiliated Cancer Hospital and Institute of Guangzhou Medical University, Guangzhou, Guangdong, P. R. China
Search for more papers by this authorJianping Xiong
Department of Oncology, The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, P. R. China
Search for more papers by this authorXianwei Ye
Department of Respiratory and Critical Care Medicine, Guizhou Provincial People's Hospital, Guiyang, Guizhou, P. R. China
Search for more papers by this authorJianchun Duan
Department of Internal Medicine, Cancer Hospital Chinese Academy of Medical Sciences, Beijing, P. R. China
Search for more papers by this authorHaihua Yang
Radiotherapy Section, Taizhou Hospital of Zhejiang Province, Linhai, Zhejiang, P. R. China
Search for more papers by this authorMeili Sun
Department of Oncology Internal Medicine, Jinan Central Hospital Affiliated to Shandong University, Jinan, Shandong, P. R. China
Search for more papers by this authorHongying Wei
Hansoh Pharmaceutical Group Co. Ltd., Shanghai, P. R. China
Search for more papers by this authorJiawei Wei
Hansoh Pharmaceutical Group Co. Ltd., Shanghai, P. R. China
Search for more papers by this authorZheyu Zhang
Hansoh Pharmaceutical Group Co. Ltd., Shanghai, P. R. China
Search for more papers by this authorQiong Wu
Hansoh Pharmaceutical Group Co. Ltd., Shanghai, P. R. China
Search for more papers by this authorCorresponding Author
Shun Lu
Department of Medical Oncology, Shanghai Chest Hospital Shanghai JiaoTong University, Shanghai, P. R. China
Correspondence
Shun Lu, MD PhD, Department of Medical Oncology, Shanghai Chest Hospital, Shanghai JiaoTong University, Shanghai, 200030, China.
Email: [email protected]
Search for more papers by this authorXiaorong Dong
Cancer Center, Union Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan, Hubei, P. R. China
Search for more papers by this authorHong Jian
Department of Medical Oncology, Shanghai Chest Hospital Shanghai JiaoTong University, Shanghai, P. R. China
Search for more papers by this authorJianhua Chen
Department of Medical Oncology-Chest, Hunan Cancer Hospital & The Affiliated Cancer Hospital of Central South University Xiangya School of Medicine, Changsha, Hunan, P. R. China
Search for more papers by this authorGongyan Chen
Thoracic Oncology Medicine, Harbin Medical University Cancer Hospital, Harbin, Heilongjiang, P. R. China
Search for more papers by this authorYuping Sun
Department of Oncology, Jinan Central Hospital, Jinan, Shandong, P. R. China
Search for more papers by this authorYinghua Ji
Department of Oncology, First Affiliated Hospital of Xinxiang Medical University, Xinxiang, Henan, P. R. China
Search for more papers by this authorZiping Wang
Department of Chest Medicine, Beijing Cancer Hospital, Beijing, P. R. China
Search for more papers by this authorJianhua Shi
Department of Internal Medicine, Linyi Cancer Hospital, Linyi, Shandong, P. R. China
Search for more papers by this authorJunguo Lu
Department of Respiratory Medicine, Nantong Tumor Hospital, Nantong, Jiangsu, P. R. China
Search for more papers by this authorShaoshui Chen
Department of Oncology, Binzhou Medical University Hospital, Binzhou, Shandong, P. R. China
Search for more papers by this authorDongqing Lv
Breath Internal Medicine, Taizhou Hospital of Zhejiang Province, Linhai, Zhejiang, P. R. China
Search for more papers by this authorGuojun Zhang
Department of Respiration, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, P. R. China
Search for more papers by this authorChunling Liu
Department of Lung Internal Medicine, Affiliated Tumor Hospital of Xinjiang Medical University, Urumqi, Xinjiang, P. R. China
Search for more papers by this authorJuan Li
Department of Thoracic Oncology, Sichuan Cancer Hospital, Chengdu, Sichuan, P. R. China
Search for more papers by this authorXinmin Yu
Thoracic Medical Oncology, Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Hangzhou, Zhejiang, P. R. China
Search for more papers by this authorZhong Lin
Department of Thoracic Oncology, The Fifth Subsidiary Sun Yat-sen University Hospital, Zhuhai, Guangdong, P. R. China
Search for more papers by this authorZhuang Yu
Department of Oncology, The Affiliated Hospital of Qingdao University, Qingdao, Shandong, P. R. China
Search for more papers by this authorZhehai Wang
Department of Oncology, Shandong Cancer Hospital, Jinan, Shandong, P. R. China
Search for more papers by this authorJiuwei Cui
Department of Oncology, The First Bethune Hospital of Jilin University, Changchun, Jilin, P. R. China
Search for more papers by this authorXingxiang Xu
Department of Respiration, Northern Jiangsu People's Hospital Affiliated to Yangzhou University, Yangzhou, Jiangsu, P. R. China
Search for more papers by this authorJian Fang
Department of Chest Medicine, Beijing Cancer Hospital, Beijing, P. R. China
Search for more papers by this authorJifeng Feng
Department of Internal Medicine, Jiangsu Cancer Hospital, Nanjing, Jiangsu, P. R. China
Search for more papers by this authorZhi Xu
Department of Respiration, The Second Affiliated Hospital of Army Medical University, Chongqing, P. R. China
Search for more papers by this authorRui Ma
Department of Chest Internal Medicine, Liaoning Cancer Hospital & Institute, Shenyang, Liaoning, P. R. China
Search for more papers by this authorJie Hu
Respiratory Medicine, Zhongshan Hospital Fudan University, Shanghai, P. R. China
Search for more papers by this authorNong Yang
Lung & Gastrointestinal Oncology Department, Hunan Cancer Hospital & The Affiliated Cancer Hospital of Central South University Xiangya School of Medicine, Changsha, Hunan, P. R. China
Search for more papers by this authorXiangdong Zhou
Department of Respiratory and Critical Care Medicine, The Southwest Hospital of AMU, Chongqing, P. R. China
Search for more papers by this authorXiaohong Wu
Department of Oncology, Affiliated Hospital of Jiangnan University, Wuxi, Jiangsu, P. R. China
Search for more papers by this authorChengping Hu
Respiratory Medicine, Xiangya Hospital Central South University, Changsha, Hunan, P. R. China
Search for more papers by this authorZhihong Zhang
Department of Respiration Oncology, Anhui Provincial Cancer Hospital, Hefei, Anhui, P. R. China
Search for more papers by this authorYou Lu
Department of Thoracic Oncology, West China Hospital of Sichuan University, Chengdu, Sichuan, P. R. China
Search for more papers by this authorYanping Hu
Department of Thoracic Oncology, Hubei Cancer Hospital, Wuhan, Hubei, P. R. China
Search for more papers by this authorLiyan Jiang
Department of Respiration, Shanghai Chest Hospital, Shanghai JiaoTong University, Shanghai, P. R. China
Search for more papers by this authorQiming wang
Department of Respiration, Henan Cancer hospital, Zhengzhou, Henan, P. R. China
Search for more papers by this authorRenhua Guo
Department of Oncology, Jiangsu Province Hospital, Nanjing, Jiangsu, P. R. China
Search for more papers by this authorJianying Zhou
Department of Respiratory Medicine, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, P. R. China
Search for more papers by this authorBaolan Li
Department of Oncology Internal Medicine, Beijing Chest Hospital, Capital Medical University, Beijing, P. R. China
Search for more papers by this authorChunhong Hu
Department of Oncology, Xiangya Second Hospital of Central South University, Changsha, Hunan, P. R. China
Search for more papers by this authorWancheng Tong
Department of Infection Internal Medicine, Nanfang Hospital, Nanfang Medical University, Guangzhou, Guangdong, P. R. China
Search for more papers by this authorHelong Zhang
Department of Oncology, The Second Affiliated Hospital of Air Force Military Medical University, Xi'an, Shanxi, P. R. China
Search for more papers by this authorLin Ma
Department of Respiration, The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, P. R. China
Search for more papers by this authorYuan Chen
Department of Oncology, Tongji Medical College Huazhong University of Science & Technology, Wuhan, Hubei, P. R. China
Search for more papers by this authorZhijun Jie
Department of Respiratory and Critical Care Medicine, Shanghai Fifth People's Hospital, Fudan University, Shanghai, P. R. China
Search for more papers by this authorYu Yao
Department of Oncology Internal Medicine, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shanxi, P. R. China
Search for more papers by this authorLongzhen Zhang
Radiotherapy Department, The Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu, P. R. China
Search for more papers by this authorJie Weng
Department of Oncology, Yueyang Central Hospital, Yueyang, Hunan, P. R. China
Search for more papers by this authorWeidong Li
Department of Internal Medicine, Affiliated Cancer Hospital and Institute of Guangzhou Medical University, Guangzhou, Guangdong, P. R. China
Search for more papers by this authorJianping Xiong
Department of Oncology, The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, P. R. China
Search for more papers by this authorXianwei Ye
Department of Respiratory and Critical Care Medicine, Guizhou Provincial People's Hospital, Guiyang, Guizhou, P. R. China
Search for more papers by this authorJianchun Duan
Department of Internal Medicine, Cancer Hospital Chinese Academy of Medical Sciences, Beijing, P. R. China
Search for more papers by this authorHaihua Yang
Radiotherapy Section, Taizhou Hospital of Zhejiang Province, Linhai, Zhejiang, P. R. China
Search for more papers by this authorMeili Sun
Department of Oncology Internal Medicine, Jinan Central Hospital Affiliated to Shandong University, Jinan, Shandong, P. R. China
Search for more papers by this authorHongying Wei
Hansoh Pharmaceutical Group Co. Ltd., Shanghai, P. R. China
Search for more papers by this authorJiawei Wei
Hansoh Pharmaceutical Group Co. Ltd., Shanghai, P. R. China
Search for more papers by this authorZheyu Zhang
Hansoh Pharmaceutical Group Co. Ltd., Shanghai, P. R. China
Search for more papers by this authorQiong Wu
Hansoh Pharmaceutical Group Co. Ltd., Shanghai, P. R. China
Search for more papers by this authorPrior presentation: Presented in part at the 2022 American Society of Clinical Oncology conference in Chicago, IL, USA as Poster # 9096.
Abstract
Background
The initial randomized, double-blinded, actively controlled, phase III ANEAS study (NCT03849768) demonstrated that aumolertinib showed superior efficacy relative to gefitinib as first-line therapy in epidermal growth factor receptor (EGFR)-mutated advanced non-small cell lung cancer (NSCLC). Metastatic disease in the central nervous system (CNS) remains a challenge in the management of NSCLC. This study aimed to compare the efficacy of aumolertinib versus gefitinib among patients with baseline CNS metastases in the ANEAS study.
Methods
Eligible patients were enrolled and randomly assigned in a 1:1 ratio to orally receive either aumolertinib or gefitinib in a double-blinded fashion. Patients with asymptomatic, stable CNS metastases were included. Follow-up imaging of the same modality as the initial CNS imaging was performed every 6 weeks for 15 months, then every 12 weeks. CNS response was assessed by a neuroradiological blinded, independent central review (neuroradiological-BICR). The primary endpoint for this subgroup analysis was CNS progression-free survival (PFS).
Results
Of the 429 patients enrolled and randomized in the ANEAS study, 106 patients were found to have CNS metastases (CNS Full Analysis Set, cFAS) at baseline by neuroradiological-BICR, and 60 of them had CNS target lesions (CNS Evaluable for Response, cEFR). Treatment with aumolertinib significantly prolonged median CNS PFS compared with gefitinib in both cFAS (29.0 vs. 8.3 months; hazard ratio [HR] = 0.31; 95% confidence interval [CI], 0.17-0.56; P < 0.001) and cEFR (29.0 vs. 8.3 months; HR = 0.26; 95% CI, 0.11-0.57; P < 0.001). The confirmed CNS overall response rate in cEFR was 85.7% and 75.0% in patients treated with aumolertinib and gefitinib, respectively. Competing risk analysis showed that the estimated probability of CNS progression without prior non-CNS progression or death was consistently lower with aumolertinib than with gefitinib in patients with and without CNS metastases at baseline. No new safety findings were observed.
Conclusions
These results indicate a potential advantage of aumolertinib over gefitinib in terms of CNS PFS and the risk of CNS progression in patients with EGFR-mutated advanced NSCLC with baseline CNS metastases.
Trial registration
ClinicalTrials.gov number, NCT03849768
CONFLICTS OF INTEREST STATEMENT
Disclosures provided by the authors are available with this article at DOI https://doi.org/10.1200/JCO.21.02641
Open Research
DATA AVAILABILITY STATEMENT
Upon request and subject to certain criteria, conditions, and exceptions, Hansoh will provide access to individual de-identified participant data from Hansoh-sponsored interventional clinical studies conducted for medicines for indications that have been approved. Data requests may be submitted to [email protected].
Supporting Information
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