Zanubrutinib in Japanese treatment-naive and relapsed/refractory patients with Waldenström macroglobulinemia and CLL/SLL

被引：0

作者：

Izutsu, Koji ^{[1
]}

Ishikawa, Takayuki ^{[2
]}

Shimada, Kazuyuki ^{[3
]}

Kubo, Kohmei ^{[4
]}

Kondo, Takeshi ^{[5
]}

Fujimoto, Katsuya ^{[6
]}

Fujisaki, Tomoaki ^{[7
]}

Kurahashi, Shingo ^{[8
]}

Nagafuji, Koji ^{[9
]}

Sakai, Rika ^{[10
]}

Jo, Tatsuro ^{[11
]}

Nakazato, Tomonori ^{[12
]}

Sunami, Kazutaka ^{[13
]}

Kasahara, Senji ^{[14
]}

Cohen, Aileen ^{[15
]}

Takai, Motohisa ^{[15
]}

Zhong, Jinhua ^{[16
]}

Takeuchi, Masahiro ^{[17
]}

机构：

[1] Natl Canc Ctr, 5-1-1 TsukijiChuo Ku, Tokyo, Japan

[2] Kobe City Med Ctr Gen Hosp, Kobe, Japan

[3] Nagoya Univ Hosp, Nagoya, Japan

[4] Aomori Prefectural Cent Hosp, Aomori, Japan

[5] Aiiku Hosp, Sapporo, Japan

[6] NHO Hokkaido Canc Ctr, Sapporo, Hokkaido, Japan

[7] Matsuyama Red Cross Hosp, Matsuyama, Ehime, Japan

[8] Toyohashi Municipal Hosp, Toyohashi, Japan

[9] Kurume Univ Hosp, Kurume, Fukuoka, Japan

[10] Kanagawa Canc Ctr, Yokohama, Kanagawa, Japan

[11] Japanese Red Cross Nagasaki Genbaku Hosp, Nagasaki, Japan

[12] Yokohama Municipal Citizens Hosp, Yokohama, Kanagawa, Japan

[13] Okayama Med Ctr, Natl Hosp Org, Okayama, Japan

[14] Gifu Municipal Hosp, Gifu, Japan

[15] BeiGene USA Inc, San Mateo, CA USA

[16] BeiGene Shanghai Co Ltd, Shanghai, Peoples R China

[17] Chiba Ken Canc Ctr, Chiba, Japan

来源：

INTERNATIONAL JOURNAL OF HEMATOLOGY | 2025年 / 121卷 / 04期

关键词：

Waldenstr & ouml; m Macroglobulinemia; Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma; Zanubrutinib; Bruton tyrosine kinase; Japanese; CHRONIC LYMPHOCYTIC-LEUKEMIA; RESPONSE ASSESSMENT; IBRUTINIB; LYMPHOMA; BTK;

D O I：

10.1007/s12185-025-03925-1

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Zanubrutinib is a selective second-generation Bruton tyrosine kinase inhibitor approved in various B-cell malignancies globally. The phase 1/2 BGB-3111-111 study evaluated the efficacy and safety of zanubrutinib 160 mg twice daily orally in Japanese patients with treatment-naive or relapsed/refractory mature B-cell malignancies. Here, efficacy results from Part 2 in chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL; n = 19) and Waldenstr & ouml;m macroglobulinemia (WM; n = 19), and safety results from Parts 1 (N = 6) and 2 (N = 49) are presented, with the first dose between 30 January, 2020, and 31 October, 2022. As of 10 May, 2023, investigator-assessed overall response rates were 100% (19/19) and 94.7% (18/19) in CLL/SLL and WM, respectively, with median follow-up of 27.9 and 26.8 months; 24-month progression-free survival rates were 71.4% and 100% in treatment-naive and relapsed/refractory CLL/SLL and 83.9% and 100% in treatment-naive and relapsed/refractory WM, respectively. In patients with B-cell malignancies, any-grade treatment-emergent adverse events (TEAEs) occurred in 53 (96.4%) and serious TEAEs in 18 (32.7%). Common TEAEs were platelet count decreased (18.2%), pyrexia (18.2%), COVID-19 (14.5%), and neutrophil count decreased (12.7%). With median follow-up > 2 years, zanubrutinib demonstrated durable efficacy in Japanese patients with CLL/SLL or WM and a favorable safety profile consistent with global phase 3 studies.

引用

页码：483 / 493

页数：11

共 23 条

[1]

[Anonymous], 2023, BRUKINSA ZANUBRUTINI

[2] Zanubrutinib or Ibrutinib in Relapsed or Refractory Chronic Lymphocytic Leukemia [J].

Brown, J. R. ;

Eichhorst, B. ;

Hillmen, P. ;

Jurczak, W. ;

Kazmierczak, M. ;

Lamanna, N. ;

O'Brien, S. M. ;

Tam, C. S. ;

Qiu, L. ;

Zhou, K. ;

Simkovic, M. ;

Mayer, J. ;

Gillespie-Twardy, A. ;

Ferrajoli, A. ;

Ganly, P. S. ;

Weinkove, R. ;

Grosicki, S. ;

Mital, A. ;

Robak, T. ;

Osterborg, A. ;

Yimer, H. A. ;

Salmi, T. ;

Wang, M. -D. -Y. ;

Fu, L. ;

Li, J. ;

Wu, K. ;

Cohen, A. ;

Shadman, M. .

NEW ENGLAND JOURNAL OF MEDICINE, 2023, 388 (04) :319-332

[3] Sustained benefit of zanubrutinib vs ibrutinib in patients with R/R CLL/SLL: final comparative analysis of ALPINE [J].

Brown, Jennifer R. ;

Eichhorst, Barbara ;

Lamanna, Nicole ;

O'Brien, Susan M. ;

Tam, Constantine S. ;

Qiu, Lugui ;

Jurczak, Wojciech ;

Zhou, Keshu ;

Simkovic, Martin ;

Mayer, Jiri ;

Gillespie-Twardy, Amanda ;

Ferrajoli, Alessandra ;

Ganly, Peter S. ;

Weinkove, Robert ;

Grosicki, Sebastian ;

Mital, Andrzej ;

Robak, Tadeusz ;

Osterborg, Anders ;

Yimer, Habte A. ;

Wang, Megan ;

Salmi, Tommi ;

Wang, Liping ;

Li, Jessica ;

Wu, Kenneth ;

Cohen, Aileen ;

Shadman, Mazyar .

BLOOD, 2024, 144 (26) :2706-2717

[4]

Brukinsa (zanubrutinib), 2023, SUMMARY PRODUCT CHAR

[5]

Brukinsa (zanubrutinib), 2023, PACKAGING INSERT

[6] Bruton Tyrosine Kinase (BTK) and Its Role in B-cell Malignancy [J].

Buggy, Joseph J. ;

Elias, Laurence .

INTERNATIONAL REVIEWS OF IMMUNOLOGY, 2012, 31 (02) :119-132

[7] Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification [J].

Cheson, Bruce D. ;

Fisher, Richard I. ;

Barrington, Sally F. ;

Cavalli, Franco ;

Schwartz, Lawrence H. ;

Zucca, Emanuele ;

Lister, T. Andrew .

JOURNAL OF CLINICAL ONCOLOGY, 2014, 32 (27) :3059-+

[8] Novel Targeted Agents and the Need to Refine Clinical End Points in Chronic Lymphocytic Leukemia [J].

Cheson, Bruce D. ;

Byrd, John C. ;

Rai, Kanti R. ;

Kay, Neil E. ;

O'Brien, Susan M. ;

Flinn, Ian W. ;

Wiestner, Adrian ;

Kipps, Thomas J. .

JOURNAL OF CLINICAL ONCOLOGY, 2012, 30 (23) :2820-2822

[9]

Dimopoulos MA, 2023, J Clin Oncol

[10] Multicenter phase 2 trial of rituximab for Waldenstrom macroglobulinemia (WM): An eastern cooperative oncology group study (E3A98) [J].

Gertz, MA ;

Rue, M ;

Blood, E ;

Kaminer, LS ;

Vesole, DH ;

Greipp, PR .

LEUKEMIA & LYMPHOMA, 2004, 45 (10) :2047-2055

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