Please use this identifier to cite or link to this item: https://repository.monashhealth.org/monashhealthjspui/handle/1/36597
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dc.contributor.authorWei R.en
dc.contributor.authorAtwal S.en
dc.contributor.authorHuang J.en
dc.contributor.authorTrotman J.en
dc.contributor.authorElstrom R.en
dc.contributor.authorTam C.S.en
dc.contributor.authorWang M.en
dc.contributor.authorSimpson D.en
dc.contributor.authorOpat S.en
dc.contributor.authorCull G.en
dc.contributor.authorMunoz J.en
dc.contributor.authorPhillips T.J.en
dc.contributor.authorKim W.en
dc.date.accessioned2021-05-14T12:25:03Zen
dc.date.available2021-05-14T12:25:03Zen
dc.date.copyright2019en
dc.date.created20190813en
dc.date.issued2019-08-13en
dc.identifier.citationHematological Oncology. Conference: 15th International Conference on Malignant Lymphoma Palazzo dei Congressi. Lugano Switzerland. 37 (Supplement 2) (pp 245-247), 2019. Date of Publication: June 2019.en
dc.identifier.issn1099-1069en
dc.identifier.urihttps://repository.monashhealth.org/monashhealthjspui/handle/1/36597en
dc.description.abstractIntroduction: Zanubrutinib, an investigational BTK inhibitor, has demonstrated greater selectivity for BTK vs other TEC- and EGFR-family kinases in biochemical assays and shown favorable PK/PD properties in preclinical studies. In phase 1 testing, high plasma concentrations were achieved, resulting in complete and sustained 24-hour BTK inhibition in blood and lymph nodes in patients (pts) treated at 160 mg twice daily (bid; Tam. Blood 2016;128:642). Here, we present updated safety and efficacy data from pts with MCL. Method(s): This is a global, phase 1 study investigating zanubrutinib in pts with B-cell malignancies with indication-specific expansion cohorts. In the expansion phase, enrolled pts received zanubrutinib 320 mg daily or 160 mg bid (the RP2D). Treatment emergent adverse events (TEAEs) were summarized according to NCI CTCAE v4.03 and responses were assessed by CT scans as per Lugano Classification (Cheson. J Clin Oncol 2014;32:3059). Result(s): As of 16 Sep 2018, 48 MCL pts were enrolled: 37 relapsed/refractory (R/R) and 11 treatment-naive (TN) (Table). Of the 48 pts, 45 were evaluable for efficacy; 3 were not efficacy evaluable as they had not yet reached the first 12-week efficacy assessment. Median follow-up for efficacy evaluable pts was 16.0 mo (range, 1.6-38.2). Twenty-six pts discontinued treatment (16 due to progressive disease [PD]; 10 due to TEAEs including peripheral edema, small cell lung cancer, renal hematoma, ANCA-positive vasculitis with acute kidney injury, subdural hematoma, and myelodysplastic syndrome, pneumonia (2 pts), congestive cardiac failure, thalamic infarction). Five pts died due to TEAEs (1 pneumonia, 1 congestive cardiac failure, 1 thalamic infarction, and 2 sepsis/septic shock), none of which were assessed by investigator as related to zanubrutinib. Most common TEAEs of any cause (>=15% of pts) included diarrhea (35%), petechiae/purpura/contusion (31%), upper respiratory tract infection (27%), fatigue (25%), constipation (21%), rash (19%), back pain (17%), headache (17%) and peripheral edema (17%). Overall response rate (ORR) for TN, R/R and overall was 87.5% (7/8), 86.5% (32/37) and 86.7% (39/45) respectively (Table). Responses were based on computed tomography scans for most pts, as positronemission tomography was not required. Median progression-free survival was 15.4 mo (Table). Conclusion(s): Zanubrutinib monotherapy was shown to be well tolerated and highly active in pts with MCL, with high ORR and rate of CR. (Table Presented).en
dc.languageEnglishen
dc.languageenen
dc.publisherJohn Wiley and Sons Ltden
dc.titleUpdated safety and efficacy data in the phase 1 trial of patients with mantle cell lymphoma (MCL) treated with bruton tyrosine kinase (BTK) inhibitor zanubrutinib (BGB-3111).en
dc.typeConference Abstracten
dc.identifier.affiliationHaematologyen
dc.type.studyortrialObservational study (cohort, case-control, cross sectional or survey)-
dc.identifier.doihttp://monash.idm.oclc.org/login?url=http://dx.doi.org/10.1002/hon.55_2630en
local.date.conferencestart2019-06-18en
dc.identifier.source628868170en
dc.identifier.institution(Tam) Department of Haematology, St. Vincent's Hospital, University of Melbourne, Melbourne, VIC, Australia (Wang) Department of Lymphoma and Myeloma, Division of Cancer Medicine, MD Anderson Cancer Center, Houston, TX, United States (Simpson) Waitemata DHB Haematology Service, North Shore Hospital, Auckland, New Zealand (Opat) Clinical Haematology,Monash Health, Monash University, Clayton, VIC, Australia (Cull) Department of Haematology, Sir Charles Gairdner Hospital, University of Western Australia, Perth, WA, Australia (Munoz) Hematology-Oncology, Banner MD Anderson Cancer Center, Gilbert, AZ, United States (Phillips) Michigan Medicine Hematology Clinic, Rogel Cancer Center, University of Michigan, Ann Arbor, MI, United States (Kim) Samsung Medical Center, Sungkyunkwan University, School of Medicine, Seoul, South Korea (Atwal, Wei, Huang, Elstrom) Research and Development Center, BeiGene (Beijing) Co., Ltd, Beijing, China (Trotman) Department of Haematology, Concord Repatriation Hospital, University of Sydney, Concord, NSW, Australiaen
dc.description.addressC.S. Tam, Department of Haematology, St. Vincent's Hospital, University of Melbourne, Melbourne, VIC, Australiaen
dc.description.publicationstatusCONFERENCE ABSTRACTen
local.date.conferenceend2019-06-22en
dc.rights.statementCopyright 2019 Elsevier B.V., All rights reserved.en
dc.subect.keywordsBTK inhibitors Mantle cell lymphoma (MCL)en
dc.identifier.affiliationext(Tam) Department of Haematology, St. Vincent's Hospital, University of Melbourne, Melbourne, VIC, Australia-
dc.identifier.affiliationext(Wang) Department of Lymphoma and Myeloma, Division of Cancer Medicine, MD Anderson Cancer Center, Houston, TX, United States-
dc.identifier.affiliationext(Simpson) Waitemata DHB Haematology Service, North Shore Hospital, Auckland, New Zealand-
dc.identifier.affiliationext(Cull) Department of Haematology, Sir Charles Gairdner Hospital, University of Western Australia, Perth, WA, Australia-
dc.identifier.affiliationext(Munoz) Hematology-Oncology, Banner MD Anderson Cancer Center, Gilbert, AZ, United States-
dc.identifier.affiliationext(Phillips) Michigan Medicine Hematology Clinic, Rogel Cancer Center, University of Michigan, Ann Arbor, MI, United States-
dc.identifier.affiliationext(Kim) Samsung Medical Center, Sungkyunkwan University, School of Medicine, Seoul, South Korea-
dc.identifier.affiliationext(Atwal, Wei, Huang, Elstrom) Research and Development Center, BeiGene (Beijing) Co., Ltd, Beijing, China-
dc.identifier.affiliationext(Trotman) Department of Haematology, Concord Repatriation Hospital, University of Sydney, Concord, NSW, Australia-
dc.identifier.affiliationmh(Opat) Clinical Haematology,Monash Health, Monash University, Clayton, VIC, Australia-
item.cerifentitytypePublications-
item.fulltextNo Fulltext-
item.grantfulltextnone-
item.openairetypeConference Abstract-
item.openairecristypehttp://purl.org/coar/resource_type/c_18cf-
crisitem.author.deptHaematology-
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