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1797 Flumatinib Versus Nilotinib for Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia

Program: Oral and Poster Abstracts
Session: 632. Chronic Myeloid Leukemia: Clinical and Epidemiological: Poster I
Hematology Disease Topics & Pathways:
Research, Therapies
Saturday, December 9, 2023, 5:30 PM-7:30 PM

Suning Chen1*, Yanli Zhang, MD2*, Na Xu3*, Hui Sun4*, Li Weiming, MD5*, Yunfan Yang6*, Zunmin Zhu, MD, PhD7*, Minghui Duan8*, Sixuan Qian9*, Yu Zhu9*, Jianmin Luo10*, Xiaodong Wang11*, Wei Yang12*, Weiying Gu13*, Fei Li14*, Bingcheng Liu, MD15*, Yunxiao Xu16*, Zhenfang Liu, MD17*, Chunling Wang, MD18*, Yirong Jiang19*, Li Meng20*, Qin Wen, MD21*, Yanli Xu22*, Xingli Zou23*, Wei Wang, MD24*, Yan Xue25*, Hao Xu26*, Kehong Bi27*, Fuling Zhou28*, Liangming Ma29*, Rong Fu30*, Guifang Ouyang31*, Kaiyang Ding32* and Depei Wu33

1National Clinical Research Center for Hematologic Diseases, Jiangsu Institute of Hematology, Collaborative Innovation Center of Hematology, the First Affiliated Hospital of Soochow University, Soochow University, Suzhou, China
2Department of Hematology, Henan Cancer Hospital, Zhengzhou, China
3Department of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China
4Department of Hematology, First Affiliated Hospital of Zhengzhou University, Zhengzhou, China
5Department of Hematology, Union Hospital, Tongji Medical Collage, Huazhong University of Science and Technology, Wuhan, China
6Department of Hematology, West China Hospital of Sichuan University, Chengdu, China
7Department of Hematology, Henan Provincial People’s Hospital, Zhengzhou, China
8Department of Hematology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, China
9Department of Hematology, Jiangsu Provincial People's Hospital, Nanjing, China
10Department of Hematology, The Second Hospital of Hebe Medical University, Shijiazhuang, Hebei, China, Shijiazhuang, China
11Department of Hematology, Sichuan Provincial People's Hospital, Chengdu, China
12Department of Hematology, Shengjing Hospital of China Medical University, Shenyang, China
13Department of Hematology, Changzhou First People's Hospital, Changzhou, China
14Department of Hematology, The First Affiliated Hospital of Nanchang University, Nanchang, China
15National Clinical Research Center for Blood Diseases, State Key Laboratory of Experimental Hematology, Haihe Laboratory of Cell Ecosystem, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences &Peking Union Medical College, Tianjin, China
16Department of Hematology, Second Xiangya Hospital of Central South University, Changsha, China
17Department of Hematology, The First Affiliated Hospital of Guangxi Medical University, Nanning, China
18Department of Hematology, Huai'an First People's Hospital, Huai'an, China
19Department of Hematology, Dongguan Hospital Affiliated to Southern Medical University, Dongguan, China
20Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
21Medical Center of Hematology, Xinqiao Hospital, State Key Laboratory of Trauma, Burn and Combined Injury, Army Medical University, Chongqing, China
22Department of Hematology, Nanjing First Hospital, Nanjing, China
23Department of Hematology, Affiliated Hospital of North Sichuan Medical College, Nanchong, China
24The Affiliated Hospital of Qingdao University, Qingdao, China
25Department of Hematology, Xuzhou Central Hospital, Xuzhou, China
26Department of Hematology, Yancheng First People's Hospital, Yancheng, China
27Department of Hematology, The First Affiliated Hospital of Shandong First Medical University, Jinan, China
28Department of Hematology, Zhongnan Hospital of Wuhan University, Wuhan, China
29Department of Hematology, Shanxi Bethune Hospital, Taiyuan, China
30Department of Hematology, Tianjin Medical University General Hospital, Tianjin, China
31Department of Hematology, Ningbo First Hospital, Ningbo, China
32Department of Hematology, The First Affiliated Hospital of University of Science and Technology of China, Hefei, China
33The First Affiliated Hospital of Soochow University, Suzhou, China


Tyrosine kinase inhibitors (TKIs) have considerably improved the long-term clinical outcomes in patients with chronic phase chronic myeloid leukemia (CML-CP). Most of these patients receive 1st generation TKI imatinib as first-line therapy; however, an increasing number of patients are now receiving 2nd generation TKIs as first-line therapy, because of the more potent BCR-ABL1 inhibition with proven efficacy in patients resistant or intolerant to imatinib. Flumatinib is a novel 2nd generation BCR-ABL1 TKI with promising efficacy and manageable safety in newly diagnosed CML-CP. Compared to imatinib, patients treated with flumatinib have achieved significantly higher rates of 12-month major molecular response (MMR) and complete cytogenetic response were observed in patients with CML-CP and that too within a shorter time duration. Though there have been many studies comparing 2nd generation TKIs vs imatinib in CML-CP, studies comparing clinical outcomes between different 2nd generation TKIs are scarce. Here, we report the real-world effectiveness and safety of flumatinib and nilotinib in patients with newly diagnosed CML-CP.


In this study, adult patients (≥18 years old) with newly diagnosed Philadelphia chromosome-positive (Ph+) CML-CP who received either 300 mg nilotinib twice daily or 600 mg flumatinib once daily, were included, with a follow-up duration of roughly 3 years (NCT04739826). The primary endpoint was the rate of MMR at 12 months as defined by European LeukemiaNet 2020 recommendations (BCR-ABL1 transcript level ≤0.1% in peripheral blood on RT-PCR assay on International Scale [IS]). The secondary endpoints were the rate of early molecular response (EMR) at 3 months (BCR-ABL1IS ≤10%), the rate of molecular response at 6 months (BCR-ABL1IS ≤ 1%) and safety (adverse events [AEs] reports in accordance to Common Terminology Criteria for Adverse Events, version 4.03).


A total of 446 patients were enrolled in the study between November 2020 and August 2022, of which 150 and 296 patients were enrolled in nilotinib and flumatinib groups, respectively. The baseline characteristics were comparable between the two groups (Table 1).

No significant difference in the rate of MMR was observed at 12 months between nilotinib and flumatinib (78% vs 80%; P=0.68). Similarly, no significant difference was observed in the rate of EMR at 3 months (85% vs 89%; P=0.26) and the rate of optimal molecular response at 6 months (93% vs 92%; P=0.70; BCR-ABL1 is ≤1%) between the two groups. The overall safety profile was similar between the two groups. However, hyperbilirubinemia (47% vs 7%), increased ALT (33% vs 12%), increased AST (24% vs 9%), rash (30% vs 18%) and anemia (19% vs 10%) were more frequent in nilotinib group than flumatinib group, whereas diarrhea was lower in nilotinib than flumatinib (2.7% vs 8.8%). The incidence rate of grade 3-4 AEs were reported to be 13% in nilotinib group and 10% in flumatinib group. The safety of flumatinib was more favorable compared to nilotinib in terms of hepatic toxicities, skin toxicities, etc. (Figure 1).


The efficacy of flumatinib is comparable to nilotinib in Chinese patients with newly diagnosed Ph+ CML-CP. The overall incidences of grade 3-4 AEs were also accessible for the two drugs, nevertheless, a few AEs inclusively hepatic toxicity, anemia and skin toxicity were remarkably lower with flumatinib intervention.

Disclosures: No relevant conflicts of interest to declare.

*signifies non-member of ASH