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Improved efficacy and safety of zanubrutinib versus ibrutinib in patients with relapsed/refractory chronic lymphocytic leukemia (R/R CLL) in China: a subgroup of ALPINE

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机构： [1]Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China. [2]National Clinical Research Center for Hematological Disorders, State Key Laboratory of Experimental Hematology, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Tianjin, China. [3]Tianjin Institutes of Health Science, Tianjin, China. [4]West China Hospital, Sichuan University, Sichuan, China. [5]Jiangsu Province Hospital, Zhejiang, China. [6]The First Hospital of Zhejiang Province, Zhejiang, China. [7]Peking Union Medical College Hospital, Beijing, China. [8]Union Hospital of Tongji Medical College, Wuhan, China. [9]Fujian Medical University Union Hospital, Fuzhou, China. [10]Nanfang Hospital of Southern Medical University, Guangzhou, China. [11]Tongji Hospital of Tongji University, Wuhan, China. [12]Shengjing Hospital of China Medical University, Shenyang, China. [13]Zhongshan Hospital of Fudan University, Shanghai, China. [14]Peking University Third Hospital, Beijing, China. [15]The First Hospital of Jilin University, Changchun, China. [16]Tianjin Medical University Cancer Institute & Hospital, Tianjin, China. [17]The First Affiliated Hospital of Wenzhou Medical University, Zhejiang, China. [18]Beijing Friendship Hospital, Beijing, China. [19]Quanzhou First Hospital of Fujian Province, Quanzhou, China. [20]Anhui Provincial Hospital, Hefei, China. [21]The First Affiliated Hospital of Nanchang University, Nanchang, China. [22]The Affiliated Hospital of Xuzhou Medical University, Jiangsu, China. [23]Guangdong Provincial People's Hospital, Guangzhou, China. [24]BeiGene, Ltd, Beijing, China. [25]BeiGene International GmbH, Basel, Switzerland. [26]BeiGene USA, Inc, San Mateo, CA, USA. [27]National Clinical Research Center for Hematological Disorders, State Key Laboratory of Experimental Hematology, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Tianjin, China. [28]Tianjin Institutes of Health Science, Tianjin, China.

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关键词： Zanubrutinib Ibrutinib Chronic lymphocytic leukemia Small lymphocytic lymphoma Chinese population

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Chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) has different epidemiology in Chinese vs. Western patients, but there are few studies of CLL/SLL in large populations of Chinese patients. ALPINE is a global phase 3 trial investigating Bruton tyrosine kinase inhibitors zanubrutinib vs. ibrutinib to treat relapsed/refractory (R/R) CLL/SLL. Here we report results from the subgroup of Chinese patients. Adults with R/R CLL/SLL were randomized 1:1 to receive zanubrutinib (160 mg twice-daily) or ibrutinib (420 mg once-daily) until disease progression or unacceptable toxicity. Endpoints included overall response rate (ORR), progression-free survival (PFS), overall survival (OS), and safety. Data were analyzed descriptively. Ninety patients were randomized in China (zanubrutinib, n = 47; ibrutinib, n = 43). Baseline characteristics were balanced between groups, with fewer male patients in the zanubrutinib vs. ibrutinib group (55.3% vs. 69.8%). Median age was 60.5 years, 11% had del(17p) mutation, and 32% had tumor protein 53 (TP53) mutation. With median 25.3 months follow-up, ORR was 80.9% with zanubrutinib vs. 72.1% with ibrutinib. PFS was improved with zanubrutinib vs. ibrutinib (HR = 0.34 [95% CI, 0.15, 0.77]), and the HR for OS was 0.45 (95% CI, 0.14, 1.50). Rates of Grade ≥ 3 treatment-emergent adverse events (TEAEs; 64.4% vs. 72.1%), AEs leading to discontinuation (6.4% vs. 14.0%), and serious TEAEs (35.6% vs. 51.2%) were lower with zanubrutinib vs. ibrutinib. Zanubrutinib demonstrated improved ORR, PFS, and OS vs. ibrutinib and a more favorable safety profile in patients with R/R CLL/SLL in China. These results are consistent with the full global population of ALPINE. ClinicalTrials.gov: NCT03734016, registered November 7, 2018.© 2024. The Author(s).

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大类 | 3 区医学

小类 | 3 区血液学

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Q2 HEMATOLOGY

影响因子： 3 最新[2023版] 3.1 最新五年平均 3 出版当年[2023版] 0 出版当年五年平均 3 出版前一年[2023版]

第一作者：

第一作者机构： [1]Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.

通讯作者：

通讯机构： [27]National Clinical Research Center for Hematological Disorders, State Key Laboratory of Experimental Hematology, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Tianjin, China. [28]Tianjin Institutes of Health Science, Tianjin, China.

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Improved efficacy and safety of zanubrutinib versus ibrutinib in patients with relapsed/refractory chronic lymphocytic leukemia (R/R CLL) in China: a subgroup of ALPINE

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