Please use this identifier to cite or link to this item: https://repository.monashhealth.org/monashhealthjspui/handle/1/44024
Title: Zanubrutinib for the treatment of relapsed or refractory mantle cell lymphoma.
Authors: Tam C.S.;Opat S. ;Simpson D.;Cull G.;Munoz J.;Phillips T.J.;Kim W.S.;Rule S.;Atwal S.K.;Wei R.;Novotny W.;Huang J.;Wang M.;Trotman J.
Monash Health Department(s): Haematology
Institution: (Opat) Monash Health, Clayton, VIC, Australia
(Tam) Peter MacCallum Cancer Centre, Melbourne, VIC, Australia
(Tam) St Vincent s Hospital, Fitzroy, VIC, Australia
(Tam) Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Parkville, VIC, Australia
(Tam) Royal Melbourne Hospital, Parkville, VIC, Australia
(Opat) Department of Haematology, Monash University, Clayton, VIC, Australia
(Simpson) North Shore Hospital, Auckland, New Zealand
(Simpson, Atwal, Wei, Novotny, Huang) BeiGene USA, Inc, San Mateo, CA, United States
(Cull) Sir Charles Gairdner Hospital, Perth, WA, Australia
(Cull) Pathology and Laboratory Medicine, University of Western Australia, Perth, WA, Australia
(Munoz) Banner MD Anderson Cancer Center, Gilbert, AZ, United States
(Phillips) Division of Hematology and Oncology, University of Michigan, Ann Arbor, MI, United States
(Kim) Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea
(Rule) Peninsula Medical School, University of Plymouth, Plymouth, United Kingdom
(Wang) University of Texas MD Anderson Cancer Center, Houston, TX, United States
(Trotman) Concord Repatriation Hospital, University of Sydney, Sydney, NSW, Australia
Issue Date: 17-Dec-2021
Copyright year: 2021
Publisher: American Society of Hematology
Place of publication: United States
Publication information: Blood Advances. 5(12) (pp 2577-2585), 2021. Date of Publication: 22 Jun 2021.
Journal: Blood Advances
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 5 14), 320 mg once daily (n 5 18), or #160 mg total dose (n 5 5). Herein, we report results for patients receiving a total daily dose of 320 mg (N 5 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.Copyright © 2021 American Society of Hematology. All rights reserved.
DOI: http://monash.idm.oclc.org/login?url=https://dx.doi.org/10.1182/bloodadvances.2020004074
PubMed URL: 34152395 [https://www.ncbi.nlm.nih.gov/pubmed/?term=34152395]
URI: https://repository.monashhealth.org/monashhealthjspui/handle/1/44024
Type: Article
Subjects: acute kidney failure
allogeneic stem cell transplantation
ANCA associated vasculitis
anemia
apoptosis
atrial fibrillation
bone marrow biopsy
brain infarction
cancer survival
computer assisted tomography
congestive heart failure
constipation
contusion
diarrhea
diffuse large B cell lymphoma
drug dose reduction
drug efficacy
drug safety
drug tolerability
drug withdrawal
epistaxis
hematoma
hematuria
hypertension
ischemic heart disease
mantle cell lymphoma
maximum tolerated dose
myalgia
myelodysplastic syndrome
neutropenia
peripheral edema
pneumonia
progression free survival
recommended drug dose
septic shock
thrombocytopenia
upper respiratory tract infection
bendamustine
bilirubin
bortezomib
rituximab
voriconazole
warfarin
zanubrutinib
zanubrutinib/ct
computed tomography scanner
PET-CT scanner
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