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Zanubrutinib Monotherapy for Naïve and Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma: A Pooled Analysis of Three Studies

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机构： [1]Department of Hematology, The First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital, Collaborative Innovation Center for Personalized Cancer Medicine, Nanjing Medical University, 300 Guangzhou Road, Nanjing, 210029, Jiangsu, China. xuwei10000@hotmail.com. [2]Peking University People's Hospital, Peking University Institute of Hematology, Beijing, China. [3]Peter MacCallum Cancer Centre, Royal Melbourne Hospital, Melbourne, VIC, Australia. [4]University of Melbourne, Parkville, VIC, Australia. [5]St Vincent's Hospital, Fitzroy, VIC, Australia. [6]Victorian Comprehensive Cancer Centre, Melbourne, VIC, Australia. [7]Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China. [8]Monash Health, Monash University, Clayton, VIC, Australia. [9]Institute of Hematology, Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Tianjin, China. [10]Concord Repatriation General Hospital, Concord, NSW, Australia. [11]University of Sydney, Concord, NSW, Australia. [12]West China Hospital of Sichuan University, Chengdu, China. [13]The First Hospital of Jilin University, Changchun, China. [14]Tongji Hospital, Tongji Medical College, Wuhan, China. [15]Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing, China. [16]Peking University Cancer Hospital, Institute (Beijing Cancer Hospital), Beijing, China. [17]Fujian Medical University Union Hospital, Fuzhou, China. [18]Nanfang Hospital of Southern Medical University, Guangzhou, China. [19]The First Hospital of Soochow University, Suzhou, China. [20]BeiGene (Beijing) Co., Ltd., Beijing, China. [21]Department of Hematology, The First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital, Collaborative Innovation Center for Personalized Cancer Medicine, Nanjing Medical University, 300 Guangzhou Road, Nanjing, 210029, Jiangsu, China.

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Zanubrutinib is a highly selective irreversible inhibitor of Bruton tyrosine kinase which has shown significant activity in lymphoid malignancies in early phase studies. We report here the long-term follow-up outcomes of zanubrutinib in various lines of therapy in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).This post hoc analysis pooled patients with treatment-naïve (TN) or relapsed/refractory (R/R) CLL/SLL receiving zanubrutinib monotherapy from three phase 1/2 studies (BGB-3111-1002, BGB-3111-AU-003, BGB-3111-205).A total of 211 patients with CLL/SLL (TN 19, R/R 192) were included. After weighting (TN 19, R/R 24), the overall response rate (ORR) was 95.4% and significantly higher in the TN group than in the R/R group (100 vs. 91.0%, p < 0.0001). ORR was also significantly higher in the TN group than in the one prior line of therapy group (100 vs. 98.9%, p < 0.0001). Among those with R/R disease, the ORR was 97.8% in patients with one prior line of therapy (n = 79) and 90.7% in those with > 1 prior lines of therapy (n = 85; p = 0.080). The median follow-up times were 50.1, 35.7, and 45.9 months for TN, R/R and all cohorts, respectively. Progression-free survival and overall survival were significantly longer in the TN group and only one prior line of therapy group compared with the > 1 prior lines of therapy group (all p < 0.05) and were similar in the TN group compared with the one prior line therapy group. Efficacy was similar regardless of the presence of genomic aberrations. Most frequent grade ≥ 3 adverse events were infections (41.7%), neutropenia (34.1%), and thrombocytopenia (9.4%). Atrial fibrillation occurred in only 1.9% of patients.With extended follow-up, zanubrutinib yielded long-term benefits and demonstrated a favorable safety profile for patients with TN or RR CLL/SLL. Earlier utilization of zanubrutinib was associated with better outcomes.Clinical Trials.gov identifiers, NCT03189524, NCT02343120 (retrospectively registered), and NCT03206918 (retrospectively registered).© 2022. The Author(s), under exclusive licence to Springer Healthcare Ltd., part of Springer Nature.

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出版当年[2022]版：

大类 | 3 区医学

小类 | 3 区医学：研究与实验 3 区药学

最新[2023]版：

大类 | 3 区医学

小类 | 3 区医学：研究与实验 3 区药学

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出版当年[2022]版：

Q2 PHARMACOLOGY & PHARMACY Q3 MEDICINE, RESEARCH & EXPERIMENTAL

最新[2023]版：

Q2 MEDICINE, RESEARCH & EXPERIMENTAL Q2 PHARMACOLOGY & PHARMACY

影响因子： 3.4 最新[2023版] 4 最新五年平均 3.8 出版当年[2022版] 4.2 出版当年五年平均 4.07 出版前一年[2021版] 3.4 出版后一年[2023版]

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第一作者机构： [1]Department of Hematology, The First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital, Collaborative Innovation Center for Personalized Cancer Medicine, Nanjing Medical University, 300 Guangzhou Road, Nanjing, 210029, Jiangsu, China. xuwei10000@hotmail.com.

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