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

Author:

Lu Shun1ORCID,Dong Xiaorong2,Jian Hong1,Chen Jianhua3,Chen Gongyan4,Sun Yuping5,Ji Yinghua6,Wang Ziping7,Shi Jianhua8,Lu Junguo9,Chen Shaoshui10,Lv Dongqing11,Zhang Guojun12,Liu Chunling13,Li Juan14,Yu Xinmin15,Lin Zhong16,Yu Zhuang17ORCID,Wang Zhehai18,Cui Jiuwei19,Xu Xingxiang20,Fang Jian7,Feng Jifeng21,Xu Zhi22,Ma Rui23,Hu Jie24,Yang Nong25,Zhou Xiangdong26,Wu Xiaohong27,Hu Chengping28,Zhang Zhihong29,Lu You30ORCID,Hu Yanping31,Jiang Liyan32,Wang Qiming33ORCID,Guo Renhua34,Zhou Jianying35,Li Baolan36,Hu Chunhong37,Tong Wancheng38,Zhang Helong39,Ma Lin40,Chen Yuan41,Jie Zhijun42,Yao Yu43,Zhang Longzhen44,Jie Weng45,Li Weidong46,Xiong Jianping47,Ye Xianwei48,Duan Jianchun49ORCID,Yang Haihua50ORCID,Sun Meili51,Sun Changan52,Wei Hongying52,Li Chuan52,Ali Siraj M.53ORCID,Miller Vincent A.53,Wu Qiong52

Affiliation:

1. Department of Medical Oncology, Shanghai Chest Hospital, Shanghai JiaoTong University, Shanghai, China

2. Cancer Center, Union Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan, China

3. Department of Medical Oncology-Chest, Hunan Cancer Hospital & The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China

4. Thoracic Oncology Medicine, Harbin Medical University Cancer Hospital, Harbin, China

5. Department of Oncology, Jinan Central Hospital, Jinan, China

6. Department of Oncology, First Affiliated Hospital of Xinxiang Medical University, Xinxiang, China

7. Department of Chest Medicine, Beijing Cancer Hospital, Beijing, China

8. Department of Internal Medicine, Linyi Cancer Hospital, Linyi, China

9. Departments of Respiratory Medicine, Nantong Tumor Hospital, Nantong, China

10. Department of Oncology, Binzhou Medical University Hospital, Binzhou, China

11. Breath Internal Medicine, Taizhou Hospital of Zhejiang Province, Linhai, China

12. Department of Respiration, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China

13. Department of Lung Internal Medicine, Affiliated Tumor Hospital of Xinjiang Medical University, Urumqi, China

14. Department of Thoracic Oncology, Sichuan Cancer Hospital, Chengdu, China

15. Thoracic Medical Oncology, Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Hangzhou, China

16. Department of Thoracic Oncology, The Fifth Subsidiary Sun Yat-sen University Hospital, Zhuhai, China

17. Department of Oncology, The Affiliated Hospital of Qingdao University, Qingdao, China

18. Department of Oncology, Shandong Cancer Hospital, Jinan, China

19. Department of Oncology, The First Bethune Hospital of Jilin University, Changchun, China

20. Department of Respiration, Northern Jiangsu People's Hospital, The Affiliated Hospital to Yangzhou University, Yangzhou, China

21. Department of Internal Medicine, Jiangsu Cancer Hospital, Jiangsu Institute of Cancer Research, The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, China

22. Department of Respiration, Xinqiao Hospital, The Second Affiliated Hospital of China PLA Army Medical University, Chongqing, China

23. Department of Chest Internal Medicine, Liaoning Cancer Hospital & Institute, Shenyang, China

24. Respiratory Medicine, Zhongshan Hospital, Fudan University, Shanghai, China

25. Lung & Gastrointestinal Oncology Department, Hunan Cancer Hospital (The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University), Changsha, China

26. Department of Respiratory and Critical Care Medicine, the Southwest Hospital of AMU, The First Affiliated Hospital of PLA Army Medical University, Chongqing, China

27. Department of Oncology, Affiliated Hospital of Jiangnan University, Wuxi, China

28. Respiratory Medicine, Xiangya Hospital Central South University, Changsha, China

29. Department of Respiration Oncology, Anhui Provincial Cancer Hospital, Hefei, China

30. Department of Thoracic Oncology, West China Hospital of Sichuan University, Chengdu, China

31. Department of Thoracic Oncology, Hubei Cancer Hospital, Wuhan, China

32. Department of Respiration, Shanghai Chest Hospital, Shanghai JiaoTong University, Shanghai, China

33. Department of Respiration, Henan Cancer Hospital, Zhengzhou, China

34. Department of Oncology, Jiangsu Province Hospital, Nanjing, China

35. Department of Respiratory Medicine, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China

36. Department of Oncology Internal Medicine, Beijing Chest Hospital, Capital Medical Hospital, Beijing, China

37. Department of Oncology, Xiangya Second Hospital of Central South University, Changsha, China

38. Department of Infection Internal Medicine, Nanfang Hospital, Nanfang Medical University, Guangzhou, China

39. Department of Oncology, The Second Affiliated Hospital of Air Force Military Medical University, Xi'An, China

40. Department of Respiration, The First Affiliated Hospital of Nanchang University, Nanchang, China

41. Department of Oncology, Tongji Medical College Huazhong University of Science & Technology, Wuhan, China

42. Department of Respiratory and Critical Care Medicine, Shanghai Fifth People's Hospital, Fudan University Shanghai, China

43. Department of Oncology Internal Medicine, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'An, China

44. Radiotherapy Department, The Affiliated Hospital of Xuzhou Medical University, Xuzhou, China

45. Department of Oncology, Yueyang Central Hospital, Yueyang, China

46. Department of Internal Medicine, Affiliated Cancer Hospital and Institute of Guangzhou Medical University, Guangzhou, China

47. Department of Oncology, The First Affiliated Hospital of Nanchang University, Nanchang, China

48. Department of Respiratory and Critical Care Medicine, GuiZhou Provincial People's Hospital, Guiyang, China

49. Department of Internal Medicine, Cancer Hospital Chinese Academy of Medical Sciences, Beijing, China

50. Radiotherapy Section, Taizhou Hospital of Zhejiang Province, Linhai, China

51. Department of Oncology Internal Medicine, Jinan Central Hospital Affiliated to Shandong University, Jinan, China

52. Hansoh Pharmaceutical Group Co. Ltd, Shanghai, China

53. EQRx, Inc, Cambridge, MA

Abstract

PURPOSE 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.

Publisher

American Society of Clinical Oncology (ASCO)

Subject

Cancer Research,Oncology

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