{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,22]],"date-time":"2026-10-22T15:29:43Z","timestamp":1792682983457,"version":"4.5.0"},"reference-count":11,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"27","content-domain":{"domain":["ascopubs.org"],"crossmark-restriction":true},"short-container-title":["JCO"],"published-print":{"date-parts":[[2022,9,20]]},"abstract":"<jats:sec><jats:title>PURPOSE<\/jats:title><jats:p> 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\u2013small-cell lung cancer (NSCLC; ClinicalTrials.gov identifier: NCT03849768 ). <\/jats:p><\/jats:sec><jats:sec><jats:title>METHODS<\/jats:title><jats:p> 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. <\/jats:p><\/jats:sec><jats:sec><jats:title>RESULTS<\/jats:title><jats:p> A total of 429 patients who were na\u00efve 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 &lt; .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 \u2265 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. <\/jats:p><\/jats:sec><jats:sec><jats:title>CONCLUSION<\/jats:title><jats:p> 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. <\/jats:p><\/jats:sec>","DOI":"10.1200\/jco.21.02641","type":"journal-article","created":{"date-parts":[[2022,5,17]],"date-time":"2022-05-17T20:00:21Z","timestamp":1652817621000},"page":"3162-3171","update-policy":"https:\/\/doi.org\/10.1200\/crossmark","source":"Crossref","is-referenced-by-count":292,"title":["AENEAS: A Randomized Phase III Trial of Aumolertinib Versus Gefitinib as First-Line Therapy for Locally Advanced or MetastaticNon\u2013Small-Cell Lung Cancer With <i>EGFR<\/i> Exon 19 Deletion or L858R Mutations"],"prefix":"10.1200","volume":"40","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8833-7262","authenticated-orcid":false,"given":"Shun","family":"Lu","sequence":"first","affiliation":[{"name":"Department of Medical Oncology, Shanghai Chest Hospital, Shanghai JiaoTong University, Shanghai, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiaorong","family":"Dong","sequence":"additional","affiliation":[{"name":"Cancer Center, Union Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hong","family":"Jian","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Shanghai Chest Hospital, Shanghai JiaoTong University, Shanghai, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jianhua","family":"Chen","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology-Chest, Hunan Cancer Hospital & The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gongyan","family":"Chen","sequence":"additional","affiliation":[{"name":"Thoracic Oncology Medicine, Harbin Medical University Cancer Hospital, Harbin, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuping","family":"Sun","sequence":"additional","affiliation":[{"name":"Department of Oncology, Jinan Central Hospital, Jinan, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yinghua","family":"Ji","sequence":"additional","affiliation":[{"name":"Department of Oncology, First Affiliated Hospital of Xinxiang Medical University, Xinxiang, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ziping","family":"Wang","sequence":"additional","affiliation":[{"name":"Department of Chest Medicine, Beijing Cancer Hospital, Beijing, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jianhua","family":"Shi","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Linyi Cancer Hospital, Linyi, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Junguo","family":"Lu","sequence":"additional","affiliation":[{"name":"Departments of Respiratory Medicine, Nantong Tumor Hospital, Nantong, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shaoshui","family":"Chen","sequence":"additional","affiliation":[{"name":"Department of Oncology, Binzhou Medical University Hospital, Binzhou, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dongqing","family":"Lv","sequence":"additional","affiliation":[{"name":"Breath Internal Medicine, Taizhou Hospital of Zhejiang Province, Linhai, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Guojun","family":"Zhang","sequence":"additional","affiliation":[{"name":"Department of Respiration, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chunling","family":"Liu","sequence":"additional","affiliation":[{"name":"Department of Lung Internal Medicine, Affiliated Tumor Hospital of Xinjiang Medical University, Urumqi, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Juan","family":"Li","sequence":"additional","affiliation":[{"name":"Department of Thoracic Oncology, Sichuan Cancer Hospital, Chengdu, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xinmin","family":"Yu","sequence":"additional","affiliation":[{"name":"Thoracic Medical Oncology, Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Hangzhou, 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China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xingxiang","family":"Xu","sequence":"additional","affiliation":[{"name":"Department of Respiration, Northern Jiangsu People's Hospital, The Affiliated Hospital to Yangzhou University, Yangzhou, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jian","family":"Fang","sequence":"additional","affiliation":[{"name":"Department of Chest Medicine, Beijing Cancer Hospital, Beijing, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jifeng","family":"Feng","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Jiangsu Cancer Hospital, Jiangsu Institute of Cancer Research, The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhi","family":"Xu","sequence":"additional","affiliation":[{"name":"Department of Respiration, Xinqiao Hospital, The Second Affiliated Hospital of China PLA Army Medical University, Chongqing, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rui","family":"Ma","sequence":"additional","affiliation":[{"name":"Department of Chest Internal Medicine, Liaoning Cancer Hospital & Institute, Shenyang, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jie","family":"Hu","sequence":"additional","affiliation":[{"name":"Respiratory Medicine, Zhongshan Hospital, Fudan University, Shanghai, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nong","family":"Yang","sequence":"additional","affiliation":[{"name":"Lung & Gastrointestinal Oncology Department, Hunan Cancer Hospital (The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University), Changsha, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiangdong","family":"Zhou","sequence":"additional","affiliation":[{"name":"Department of Respiratory and Critical Care Medicine, the Southwest 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