Ensartinib in Resected ALK-Positive Non–Small-Cell Lung Cancer

Author(s): Dongsheng Yue, M.D.1; Meijuan Huang, M.D.2; Pingping Song, M.D.3; Yuejun Chen, M.D.4; Bin Li, M.D.5; Junke Fu, M.D.6; Jianji Guo, M.M.7; Chao Cheng, M.D.8; Qixun Chen, M.D.9; Shidong Xu, Ph.D.10; Hongxu Liu, Ph.D.11; Fang Lv, M.D.12; Jian Hu, M.D.13; Ke Jiang, M.D.14; Weimin Mao, M.D.15; Bo Shen, M.D.16; Feng Ye, M.D.17; Jie Li, M.D.18; Xueying Zhang, M.D.19; Shiping Guo, M.D.20; Bentong Yu, M.D.21; Yuming Zhu, M.D.22; Ming Wu, M.D.23; Wei Zheng, M.D.24; Fang Chen, M.M.25; Zhengfu He, M.D.26; Yuansong Bai, M.D., Ph.D.27; Hua Xin, M.D.28; Keneng Chen, M.D.29; Naiquan Mao, B.M.30; Yu Zhang, M.D.31; Bo Wang, M.D.32; Lei Zhang, M.D.33; Xingwu Chen, M.D.34; Xinyu Mei, M.D.35; Liyun Miao, M.D., Ph.D.36; Runjie Wang, M.D.37; Gaofeng Li, M.D.38; Juntao Yao, M.M.39; Jun Zhao, M.D.40; Chun Chen, M.D.41; Junfeng Liu, M.D.42; Li Wei, M.D.43; Xiaolong Yan, M.D.44; Bo Jin, M.D.45; Xianling Liu, M.D.46; Zhidong Liu, M.D., Ph.D.47; Hui Tian, M.D.48; Wenqun Xing, B.S.49; Lin Yang, M.D.50; Di Ge, M.D.51; Xiangnan Li, M.D.52; Shanqing Li, M.D.53; Yongxiang Song, M.M.54; Aimin Zang, M.D.55; Dahai Zhang, B.S.56; Wu Zhuang, B.S.57; Zijin Liu, M.Sc.58; Xiaobin Yuan, M.M.58; Tao Fu, M.Sc.58; Zhilin Shen, M.Sc.58; Xiaojun Zhang, B.S.58; Qiuyue Cao, M.D.58; Luyang Zhao, M.Sc.58; Li Mao, M.D.58; Lieming Ding, M.D.58; You Lu, M.D.2; Changli Wang, M.D.1; the ELEVATE Study Group*;
Source: DOI: 10.1056/NEJMoa2518990
Original Article
Professional photo of Anjan J Patel, MD

Dr. Anjan Patel's Thoughts

It seems the old cliche of more drugs than patients is becoming true for most providers here. The data needs to mature further here but likely this will be another option for Anaplastic lymphoma kinase (ALK)+ non–small-cell lung cancer (NSCLC) patients in the adjuvant setting. It does look like CNS protection benefits are meaningful as well.

BACKGROUND

Anaplastic lymphoma kinase (ALK) inhibitors have emerged as promising agents for patients with resectable ALK-positive non–small-cell lung cancer (NSCLC). Whether ensartinib, a second-generation ALK inhibitor, is safe and effective in such patients is unknown.

METHODS

In this phase 3, double-blind, randomized trial involving patients with completely resected, ALK-positive stage IB to IIIB NSCLC after adjuvant chemotherapy, we randomly assigned patients in a 1:1 ratio to receive ensartinib a dose of 225 mg once daily or placebo for 24 months. The primary end point was disease-free survival in patients with stage II to IIIB NSCLC. The key secondary end point was disease-free survival in the overall patient population. Research Summary Ensartinib in Resected ALK-Positive Non–Small-Cell Lung Cancer

RESULTS

A total of 274 patients were randomly assigned to receive ensartinib or placebo (137 patients in each group). 24 months, the percentage of patients with stage II to IIIB disease who were alive and disease-free was 86.4% in the ensartinib group and 53.5% in the placebo group (hazard ratio for disease recurrence or death, 0.20; 95% confidence interval [CI], 0.11 to 0.38; P

CONCLUSIONS

Among patients with completely resected stage IB to IIIB ALK-positive NSCLC, the percentage of patients who were alive and disease-free 24 months was significantly higher with ensartinib than with placebo. (Funded by Betta Pharmaceuticals; ELEVATE ClinicalTrials.gov number, NCT05341583.) Quick Take Ensartinib in Resected ALK-Positive NSCLC 2m 4s

Author Affiliations

1Department of Lung Cancer, Tianjin Medical University Institute and Hospital, Tianjin, China; 2Division of Thoracic Tumor Multimodality Treatment and Department of Medical Oncology, Cancer Center, West China Hospital, Sichuan University, Chengdu; 3Department of Thoracic Surgery, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, China; 4Department of Thoracic Surgery, Hunan Cancer Hospital, Changsha, China; 5Department of Thoracic Surgery, Second Hospital and Clinical Medical School, Lanzhou University, Lanzhou, China; 6Department of Thoracic Surgery, First Affiliated Hospital of Xi’an Jiaotong University, Xi’an, China; 7Department of Cardiothoracic Surgery, First Affiliated Hospital of Guangxi Medical University, Nanning, China; 8Department of Thoracic Surgery, First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China; 9Department of Thoracic Oncological Surgery, Zhejiang Cancer Hospital, Hangzhou, China; 10Department of Thoracic Surgery, Harbin Medical University Cancer Hospital, Harbin, China; 11Department of Thoracic Surgery, Cancer Hospital of Dalian University of Technology, Liaoning Cancer Hospital and Institute, Shenyang, China; 12Department of Thoracic Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing; 13Department of Thoracic Surgery, First Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China; 14Department of Thoracic Surgery, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; 15Department of Thoracic Surgery, Jiangxi Cancer Hospital, Nanchang, China; 16Department of Oncology, Jiangsu Cancer Hospital, Nanjing, China; 17Department of Medical Oncology, First Affiliated Hospital of Xiamen University, Xiamen, China; 18Department of General Surgery, First Medical Center of Chinese People’s Liberation Army (PLA) General Hospital, Beijing; 19Department of Oncology, Jilin Cancer Hospital, Jilin, Changchun, China; 20Department of Thoracic Surgery, Shanxi Provincial Cancer Hospital, Taiyuan, China; 21Department of Thoracic Surgery, First Affiliated Hospital of Nanchang University, Nanchang, China; 22Department of Thoracic Surgery, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai; 23Department of Thoracic Surgery, Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China; 24Department of Oncology, Shengjing Hospital of China Medical University, Shenyang, China; 25Department of Respiratory and Critical Care Medicine, General Hospital of Ningxia Medical University, Yinchuan, China; 26Department of Thoracic Surgery, Sir Run Run Shaw Hospital, Zhejiang University, Hangzhou, China; 27Department of Hematology, China-Japan Union Hospital of Jilin University, Changchun, China; 28Department of Thoracic Surgery, China-Japan Union Hospital of Jilin University, Changchun, China; 29Department I of Thoracic Surgery, Peking University Cancer Hospital and Institute, Beijing; 30Department of Thoracic Surgery, the Tumor Hospital Affiliated to Guangxi Medical University, Nanning, China; 31Department of Oncology, Guizhou Provincial People’s Hospital, Guiyang, China; 32Department of Thoracic Surgery, Renmin Hospital of Wuhan University, Wuhan, China; 33Department of Thoracic Surgery, First Affiliated Hospital of Bengbu Medical University, Bengbu, China; 34Department of Respiratory Medicine, First Affiliated Hospital of Wannan Medical College, Wuhu, China; 35Department of Thoracic Surgery, First Affiliated Hospital of University of Science and Technology of China (USTC), Hefei, China; 36Department of Respiratory Medicine, Nanjing Drum Tower Hospital, Nanjing, China; 37Department of Oncology, Affiliated Wuxi People’s Hospital of Nanjing Medical University, Wuxi People’s Hospital, Wuxi, China; 38Department of Thoracic Surgery, Yunnan Cancer Hospital, Kunming, China; 39Department of Integrated Chinese and Western Medicine, Shaanxi Provincial Cancer Hospital Affiliated to Medical College of Xi’an Jiaotong University, Xi’an, China; 40Department of Thoracic Surgery, First Affiliated Hospital of Soochow University, Suzhou, China; 41Department of Thoracic Surgery, Fujian Medical University Union Hospital, Fuzhou, China; 42Department of Thoracic Surgery, Fourth Hospital of Hebei Medical University, Shijiazhuang, China; 43Department of Thoracic Surgery, Henan Provincial People’s Hospital, Zhengzhou, China; 44Department of Thoracic Surgery, Tangdu Hospital, Xi’an, China; 45Department of Medical Oncology, First Hospital of China Medical University, Shenyang, China; 46Department of Oncology, Second Xiangya Hospital, Central South University, Changsha, China; 47Department of Thoracic Surgery, Beijing Chest Hospital, Beijing; 48Department of Thoracic Surgery, Qilu Hospital of Shandong University, Jinan, China; 49Department of Thoracic Surgery, Henan Cancer Hospital, Zhengzhou, China; 50Department of Thoracic Surgery, Shenzhen People’s Hospital, Shenzhen, China; 51Department of Thoracic Surgery, Zhongshan Hospital, Fudan University, Shanghai; 52Department of Thoracic Surgery, First Affiliated Hospital of Zhengzhou University, Zhengzhou, China; 53Department of Thoracic Surgery, Peking Union Medical College Hospital, Beijing; 54Department of Thoracic Surgery, Affiliated Hospital of Zunyi Medical University, Zunyi, China; 55Department of Oncology, Affiliated Hospital of Hebei University, Baoding, China; 56Department of Radiotherapy, Dongyang People’s Hospital, Jinhua, China; 57Department of Thoracic Oncology, Fujian Cancer Hospital, Fuzhou, China; 58Betta Pharmaceuticals, Hangzhou, China

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