Zanubrutinib for the treatment of relapsed or refractory mantle cell lymphoma

Blood Advances - Tập 5 Số 12 - Trang 2577-2585 - 2021
Constantine S. Tam1,2,3,4, Stephen Opat5,6, David Simpson7,8, Gavin Cull9,10, Javier Muñoz11, Tycel Phillips12, Won Seog Kim13, Simon Rule14, Siminder Atwal7, Rachel Wei7, William Novotny7, Jane Huang7, Michael Wang15, Judith Trotman16
1Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Parkville, VIC, Australia
2Peter MacCallum Cancer Centre, Melbourne, VIC, Australia
3Royal Melbourne Hospital, Parkville, VIC, Australia
4St Vincent's Hospital, Fitzroy, VIC, Australia
5Department of Haematology, Monash University, Clayton, VIC, Australia;
6Department of Haematology, Monash University, Clayton, VIC, Australia;; Monash Health, Clayton, VIC, Australia;
7BeiGene USA, Inc., San Mateo, CA
8BeiGene USA, Inc., San Mateo, CA;; North Shore Hospital, Auckland, New Zealand;
9Pathology and Laboratory Medicine, University of Western Australia, Perth, WA, Australia
10Pathology and Laboratory Medicine, University of Western Australia, Perth, WA, Australia;; Sir Charles Gairdner Hospital, Perth, WA, Australia;
11Banner MD Anderson Cancer Center, Gilbert, AZ
12Division of Hematology and Oncology, University of Michigan, Ann Arbor, MI
13Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea
14Peninsula Medical School, University of Plymouth, Plymouth, United Kingdom
15The University of Texas MD Anderson Cancer Center, Houston, TX; and
16Concord Repatriation Hospital, The University of Sydney, Sydney, NSW, Australia

Tóm tắt

Abstract Zanubrutinib, a highly selective Bruton tyrosine kinase inhibitor, was evaluated in a phase 1/2 study in patients with various B-cell malignancies. In the subgroup of patients with relapsed/refractory (R/R) mantle cell lymphoma (MCL), zanubrutinib was administered as 160 mg twice daily (n = 14), 320 mg once daily (n = 18), or ≤160 mg total dose (n = 5). Herein, we report results for patients receiving a total daily dose of 320 mg (N = 32). Median study follow-up was 18.8 months. Eighteen patients discontinued treatment, 10 because of progressive disease and 8 because of adverse events (AEs); 1 AE (peripheral edema) was considered to be related to zanubrutinib treatment. The most common AEs were diarrhea (43.8%), contusion (37.5%), constipation (31.3%), and upper respiratory tract infection (31.3%). Infection was the most commonly reported AE of interest (18.8% of patients experienced grade ≥3 infection). At least 1 AE of grade ≥3 was reported in 59.4% of patients; grade ≥3 AEs that were reported in >2 patients were anemia (12.5%), pneumonia (9.4%), and myalgia (9.4%). Overall response rate was 84%, with 25% achieving a complete response. Median duration of response was 18.5 months. Median progression-free survival (PFS) was 21.1 months. Zanubrutinib was well tolerated and demonstrated activity in patients with R/R MCL. The trial is registered at www.clinicaltrials.gov as #NCT02343120.

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Blood Advances

Tập 5 Số 12

2577-2585

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