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Clinical Trials: Targeted Therapy

Flumatinib versus Imatinib for Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia: A Phase III, Randomized, Open-label, Multi-center FESTnd Study

Li Zhang, Li Meng, Bingcheng Liu, Yanli Zhang, Huanling Zhu, Jiuwei Cui, Aining Sun, Yu Hu, Jie Jin, Hao Jiang, Xi Zhang, Yan Li, Li Liu, Wanggang Zhang, Xiaoli Liu, Jian Gu, Jianhui Qiao, Guifang Ouyang, Xin Liu, Jianmin Luo, Ming Jiang, Xiaobao Xie, Jianyong Li, Chunting Zhao, Mei Zhang, Tonghua Yang and Jianxiang Wang
Li Zhang
1State Key Laboratory of Experimental Hematology, National Clinical Research Center for Blood Diseases, Institute of Hematology, Chinese Academy of Medical Sciences, Tianjin, P.R. China.
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Li Meng
2Tongji Hospital Tongji Medical College of Huazhong University of Science &Technology, Wuhan, Hubei, P.R. China.
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Bingcheng Liu
1State Key Laboratory of Experimental Hematology, National Clinical Research Center for Blood Diseases, Institute of Hematology, Chinese Academy of Medical Sciences, Tianjin, P.R. China.
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Yanli Zhang
3Henan Cancer Hospital, Zhengzhou, Henan, P.R. China.
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Huanling Zhu
4The West China College of Medicine, Sichuan University, Chengdu, Sichuan, P.R. China.
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Jiuwei Cui
5The First Hospital of Jilin University, Changchun, Jilin, P.R. China.
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Aining Sun
6The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology, Suzhou, Jiangsu, P.R. China.
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Yu Hu
7Union Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan, Hubei, P.R. China.
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Jie Jin
8The First Affiliated Hospital Zhejiang University, Hangzhou, Zhejiang, P.R. China.
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Hao Jiang
9Peking University People's Hospital, Peking University Institute of Hematology, Beijing, P.R. China.
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Xi Zhang
10The Second Affiliated Hospital of Army Medical University, Chongqing, P.R. China.
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Yan Li
11The First Hospital of China Medical University, Shenyang, P.R. China.
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Li Liu
12Tangdu Hospital, Fourth Military Medical University, Xi'an, Shaanxi, P.R. China.
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Wanggang Zhang
13The Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, P.R. China.
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Xiaoli Liu
14Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, P.R. China.
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Jian Gu
15Clinical Medical College of Yangzhou University/Yangzhou Institute of Hematology, Yangzhou, Jiangsu, P.R. China.
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Jianhui Qiao
16The 307th Hospital of Military Chinese People's Liberation Army, Beijing, P.R. China.
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Guifang Ouyang
17Ningbo First Hospital, Ningbo, Zhejiang, P.R. China.
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Xin Liu
18AnHui Provincial Hospital, Hefei, Anhui, P.R. China.
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Jianmin Luo
19Hebei Medical University Second Hospital, Shijiazhuang, Hebei, P.R. China.
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Ming Jiang
20The First Affiliated Hospital of Xinjiang Medical University, Urumqi, P.R. China.
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Xiaobao Xie
21The First People's Hospital of Changzhou, Changzhou, Jiangsu, P.R. China.
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Jianyong Li
22The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, P.R. China.
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Chunting Zhao
23The Affiliated Hospital of Qingdao University, Qingdao, Shandong, P.R. China.
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Mei Zhang
24The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, P.R. China.
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Tonghua Yang
25The First People's Hospital of Yunnan Province, Kunming, Yunnan, P.R. China.
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Jianxiang Wang
1State Key Laboratory of Experimental Hematology, National Clinical Research Center for Blood Diseases, Institute of Hematology, Chinese Academy of Medical Sciences, Tianjin, P.R. China.
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  • ORCID record for Jianxiang Wang
  • For correspondence: wangjx@ihcams.ac.cn
DOI: 10.1158/1078-0432.CCR-20-1600 Published January 2021
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Abstract

Purpose: Flumatinib has been shown to be a more potent inhibitor of BCR-ABL1 tyrosine kinase than imatinib. We evaluated the efficacy and safety of flumatinib versus imatinib, for first-line treatment of chronic phase Philadelphia chromosome–positive chronic myeloid leukemia (CML-CP).

Patients and Methods: In this study, 394 patients were randomized 1:1 to flumatinib 600 mg once daily (n = 196) or imatinib 400 mg once daily (n = 198) groups.

Results: The rate of major molecular response (MMR) at 6 months (primary endpoint) was significantly higher with flumatinib than with imatinib (33.7% vs. 18.3%; P = 0.0006), as was the rate of MMR at 12 months (52.6% vs. 39.6%; P = 0.0102). At 3 months, the rate of early molecular response (EMR) was significantly higher in patients receiving flumatinib than in those receiving imatinib (82.1% vs. 53.3%; P < 0.0001). Compared with patients receiving imatinib, more patients receiving flumatinib achieved molecular remission 4 (MR4) at 6, 9, and 12 months (8.7% vs. 3.6%, P = 0.0358; 16.8% vs. 5.1%, P = 0.0002; and 23.0% vs. 11.7%, P = 0.0034, respectively). No patients had progression to accelerated phase or blast crisis in the flumatinib arm versus 4 patients in the imatinib arm by 12 months. Adverse events of edema, pain in extremities, rash, neutropenia, anemia, and hypophosphatemia were more frequent in imatinib arm, whereas diarrhea and alanine transaminase elevation were more frequent in flumatinib arm.

Conclusions: Patients receiving flumatinib achieved significantly higher rates of responses, and faster and deeper responses compared with those receiving imatinib, indicating that flumatinib can be an effective first-line treatment for CML-CP. This trial was registered at www.clinicaltrials.gov as NCT02204644.

See related commentary by Müller, p. 3

Footnotes

  • Note: Supplementary data for this article are available at Clinical Cancer Research Online (http://clincancerres.aacrjournals.org/).

  • Prior presentation: Presented, in part, at 2019 American Society of Clinical Oncology (ASCO) Annual Meeting, 31 May–4 June 2019, Chicago, Illinois. Abstract 7004.

  • Clin Cancer Res 2021;27:70–7

  • Received April 30, 2020.
  • Revision received June 26, 2020.
  • Accepted September 10, 2020.
  • Published first September 14, 2020.
  • ©2020 American Association for Cancer Research.
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Clinical Cancer Research: 27 (1)
January 2021
Volume 27, Issue 1
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Flumatinib versus Imatinib for Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia: A Phase III, Randomized, Open-label, Multi-center FESTnd Study
Li Zhang, Li Meng, Bingcheng Liu, Yanli Zhang, Huanling Zhu, Jiuwei Cui, Aining Sun, Yu Hu, Jie Jin, Hao Jiang, Xi Zhang, Yan Li, Li Liu, Wanggang Zhang, Xiaoli Liu, Jian Gu, Jianhui Qiao, Guifang Ouyang, Xin Liu, Jianmin Luo, Ming Jiang, Xiaobao Xie, Jianyong Li, Chunting Zhao, Mei Zhang, Tonghua Yang and Jianxiang Wang
Clin Cancer Res January 1 2021 (27) (1) 70-77; DOI: 10.1158/1078-0432.CCR-20-1600

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Flumatinib versus Imatinib for Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia: A Phase III, Randomized, Open-label, Multi-center FESTnd Study
Li Zhang, Li Meng, Bingcheng Liu, Yanli Zhang, Huanling Zhu, Jiuwei Cui, Aining Sun, Yu Hu, Jie Jin, Hao Jiang, Xi Zhang, Yan Li, Li Liu, Wanggang Zhang, Xiaoli Liu, Jian Gu, Jianhui Qiao, Guifang Ouyang, Xin Liu, Jianmin Luo, Ming Jiang, Xiaobao Xie, Jianyong Li, Chunting Zhao, Mei Zhang, Tonghua Yang and Jianxiang Wang
Clin Cancer Res January 1 2021 (27) (1) 70-77; DOI: 10.1158/1078-0432.CCR-20-1600
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