Flumatinib for Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia: An Open-Label, Multi-Center Study

Xu, Na

Oral and Poster Abstracts
632. Chronic Myeloid Leukemia: Clinical and Epidemiological: Poster II

Research, clinical trials, Clinical Research

Ziyu Wen¹^*, Ying Zhao²^*, Guowei Li³^*, YongZhong Su⁴^*, FeiHeng Chen⁴^*, HongFang Tao⁴^*, ZhengJin Zheng⁵^*, Wuqiang Lin⁶^*, XiuLi Chen⁶^*, Meili Meng⁷^*, Lian Yu⁸^*, LongTian Chen⁸^*, JianQing Huang⁸^*, Guocai Wu⁹^*, Mengxia Zhao¹⁰^*, Zhenfang Liu, MD¹¹^*, Hongqian Zhu¹²^*, Yirong Jiang¹⁰^*, Qifa Liu, MD¹³, Xiaoli Liu¹⁴^* and Na Xu¹⁴^*

¹Department of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, AL, China
²Department of Hematology, The First People’s Hospital of Foshan, Foshan, China
³Department of Hematology, Huizhou Municipal Central Hospital, Huizhou, China
⁴Department of Hematology, The First Affiliated Hospital of Shantou University Medical College, Shantou, China
⁵Department of Hematology, Fujian Medical University Union Hospital, Fuzhou, China
⁶Department of Hematology, The First Hospital of Putian City, Putian, China
⁷Department of Hematology, Ganzhou People’s Hospital, Ganzhou, China
⁸Department of Hematology, Longyan First Hospital Affiliated Fujian Medical University, Longyan, China
⁹Department of Hematology, Central People’s Hospital of Zhanjiang, Zhanjiang, China
¹⁰Department of Hematology, Dongguan Hospital Affiliated to Southern Medical University, Dongguan, China
¹¹Department of Hematology, The First Affiliated Hospital of Guangxi Medical University, Nanning, China
¹²Department of Hematology, Guizhou Provincial People’s Hospital, Guiyang, China
¹³Nanfang Hospital, Southern Medical University, Guangzhou, China
¹⁴Department of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China

Background Tyrosine kinase inhibitors (TKIs) ushered in the era of targeted therapy for chronic myeloid leukemia(CML), which greatly improved the prognosis of patients with CML. Flumatinib is a second-generation tyrosine kinase inhibitor (TKI), which is currently approved for patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in China. And some current clinical trials revealed that flumatinib has been shown to be a more potent inhibitor of BCR::ABL than imatinib.

Methods In this open label, single-arm, multicenter study, 127 patients with newly diagnosed chronic-phase chronic myeloid leukemia (CP-CML) treated with flumatinib were enrolled. The primary endpoint of this study was early molecular response (EMR) rates at 3 months. The secondary were the rates of complete cytogenic response (CCyR), major molecular response (MMR) at 3, 6, 12 months and treatment-related adverse events (AEs). The trial is registered with ClinicalTrials.gov NCT04591197.

Results From October 2020 to December 2022, a total of 158 patients with CP-CML were assessed for eligibility, of whom 127 were followed up for more than 3 months. 79(62%) patients were men and 48 (38%) were women. The median age was 47 years (range, 19-82 years), The median time from diagnosis to treatment was 6 days (0-176 days) and the median follow-up was 9.7 months (range 3.1-26.6 months). Of evaluable 127 patients, EMR was achieved by 85% (95% confidence interval [CI], 77.6%-90.7%) of patients at 3 months. After the initiation of flumatinib treatment, the incidence of MMR at 3, 6, and 12 months was 24%, 59%, and 73%, respectively. Patients receiving flumatinib had higher rates of CCyR at 6 months and MMR 12 months than the data from DASISION (dasatinib) and ENESTnd (nilotinib) therapy (85% vs 73% vs 67% and 73% vs 46% vs 44%). Progression-free survival (PFS) rate at 1-year was 97.2%. Diarrhea (34%) were the most commonly reported adverse events. Most treatment-related adverse events were grade 1/2. None of the patients discontinued or died due to AEs.

Conclusion Flumatinib as first-line therapy in patients with newly diagnosed CP-CML was not inferior to nilotinib and dasatinib and well tolerated.

Disclosures: No relevant conflicts of interest to declare.

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3175 Flumatinib for Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia: An Open-Label, Multi-Center Study