Please use this identifier to cite or link to this item:
https://repository.monashhealth.org/monashhealthjspui/handle/1/26861
Title: | Zanubrutinib for the treatment of patients with Waldenstrom macroglobulinemia: 3 years of follow-up. | Authors: | Trotman J.;Marlton P.;Cull G.;Munoz J.;Tedeschi A.;Roberts A.W.;Seymour J.F.;Atwal S.K.;Yu Y.;Novotny W.;Holmgren E.;Tan Z.;Hilger J.D.;Huang J.;Tam C.S.;Simpson D.;Gottlieb D.;Opat S. | Monash Health Department(s): | Haematology | Institution: | (Trotman) Department of Haematology, Concord Repatriation General Hospital and Faculty of Medicine and Health, University of Sydney, Concord, NSW, Australia (Opat) Clinical Haematology Unit, Monash Health and Monash University, Clayton, VIC, Australia (Gottlieb) Faculty of Medicine and Health, University of Sydney, Westmead Hospital Sydney, Sydney, NSW, Australia (Simpson) North Shore Hospital, Auckland, New Zealand (Simpson, Atwal, Novotny, Holmgren, Hilger, Huang) BeiGene USA, Inc., San Mateo, CA, United States (Marlton) Department of Haematology, Princess Alexandra Hospital, Woolloongabba, Brisbane, QLD, Australia (Marlton) University of Queensland Faculty of Medicine, Brisbane, QLD, Australia (Cull) Haematology Department, Sir Charles Gairdner Hospital, Nedlands, WA, Australia (Cull) Department of Lymphoma/Myeloma, University of Western Australia, Perth, WA, Australia (Munoz) Banner Md Anderson Cancer Center, Gilbert, AZ, United States (Tedeschi) Asst Grande Ospedale Metropolitano Niguarda, Milan, Italy (Roberts, Seymour, Tam) Haematology Department, PeterMacCallum Cancer Centre and Royal Melbourne Hospital, Melbourne, VIC, Australia (Seymour, Tam) Department of Medicine, University of Melbourne, Melbourne, VIC, Australia (Yu, Tan) BeiGene (Shanghai) Co., Ltd., Shanghai, China (Tam) St. Vincent's Hospital, Fitzroy, VIC, Australia | Issue Date: | 28-Mar-2021 | Copyright year: | 2020 | Publisher: | American Society of Hematology | Place of publication: | United States | Publication information: | Blood. 136 (18) (pp 2027-2037), 2020. Date of Publication: 29 Oct 2020. | Journal: | Blood | Abstract: | Inhibitors of Bruton's tyrosine kinase (BTK) have established therapeutic activity in patients with Waldenstrom macroglobulinemia (WM). Zanubrutinib, a potent and selective BTK inhibitor, was evaluated in a phase 1/2 study in patients withWM who were either treatmentna ive (TN) or had relapsed/refractory (R/R) disease. Patients had disease requiring treatment per InternationalWorkshop onWaldenstromMacroglobulinemia (IWWM) criteria. Treatment was 160 mg of oral zanubrutinib twice daily (n 5 50) or 320 mg once daily (n 5 23). Efficacy endpoints included overall response rate (ORR) and very good partial response/complete response (VGPR/CR) rates per IWWM-6 criteria (with modification of VGPR definition published previously). Between September 2014 and March 2018, 77 patients (24 TN and 53 R/R) began treatment. At a median follow-up of 36.0months for patientswith R/R disease and 23.5 months for TN, 72.7% remained on treatment. Reasons for treatment discontinuation included any adverse events in 13.0% of patients (1 treatment related), disease progression (10.4%), and other (3.9%). The ORR was 95.9%, and the VGPR/CR rate was 45.2%, which increased over time: 20.5% at 6 months, 32.9% at 12 months, and 43.8% at 24months. Estimated 3-year progression-free survival rate was 80.5%, and overall survival rate was 84.8%. Adverse events of interest included contusion (32.5%, all grade 1), neutropenia (18.2%), major hemorrhage (3.9%), atrial fibrillation/flutter (5.2%), and grade 3 diarrhea (2.6%). Long-term treatment with singleagent zanubrutinib resulted in deep and durable responses in some patients with WM. The safety profile of long-term zanubrutinib therapy in these patients was acceptable. This trial was registered at www.clinicaltrials.gov as #NCT02343120.Copyright © 2020 by The American Society of Hematology. | DOI: | http://monash.idm.oclc.org/login?url= http://monash.idm.oclc.org/login?url=http://dx.doi.org/10.1182/BLOOD.2020006449 |
PubMed URL: | 32698195 [http://www.ncbi.nlm.nih.gov/pubmed/?term=32698195] | ISSN: | 0006-4971 | URI: | https://repository.monashhealth.org/monashhealthjspui/handle/1/26861 | Type: | Article | Type of Clinical Study or Trial: | Randomised controlled trial |
Appears in Collections: | Articles |
Show full item record
Items in Monash Health Research Repository are protected by copyright, with all rights reserved, unless otherwise indicated.