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    The Magnolia Trial: Zanubrutinib, a next-generation bruton tyrosine kinase inhibitor, demonstrates safety and efficacy in relapsed/refractory marginal zone lymphoma

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    Authors
    Opat, S.
    Tedeschi, A.
    Linton, Kim M
    McKay, P.
    Hu, B.
    Chan, H.
    Jin, J.
    Sobieraj-Teague, M.
    Zinzani, P. L.
    Coleman, M.
    Thieblemont, C.
    Browett, P.
    Ke, X.
    Sun, M.
    Marcus, R.
    Portell, C. A.
    Ardeshna, K.
    Bijou, F.
    Walker, P.
    Hawkes, E. A.
    Mapp, S.
    Ho, S. J.
    Talaulikar, D.
    Zhou, K. S.
    Co, M.
    Li, X.
    Zhou, W.
    Cappellini, M.
    Tankersley, C.
    Huang, J.
    Trotman, J.
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    Affiliation
    Clinical Haematology, Monash Health Department of Hematology, Niguarda Hospital
    Issue Date
    2021
    
    Metadata
    Show full item record
    Abstract
    Purpose: Marginal zone lymphoma (MZL) is an uncommon non-Hodgkin lymphoma with malignant cells that exhibit a consistent dependency on B-cell receptor signaling. We evaluated the efficacy and safety of zanubrutinib, a next-generation selective Bruton tyrosine kinase inhibitor, in patients with relapsed/refractory (R/R) MZL. Experimental design: Patients with R/R MZL were enrolled in the phase 2 MAGNOLIA (BGB-3111-214) study. The primary endpoint was overall response rate (ORR) as determined by an independent review committee (IRC) based on the Lugano 2014 classification. Results: Sixty-eight patients were enrolled. After a median follow-up of 15.7 months (range, 1.6 to 21.9 months), the IRC-assessed ORR was 68.2% and complete response (CR) was 25.8%. The ORR by investigator assessment was 74.2%, and the CR rate was 25.8%. The median duration of response (DOR) and median progression-free survival (PFS) by independent review was not reached. The IRC-assessed DOR rate at 12 months was 93.0%, and IRC-assessed PFS rate was 82.5% at both 12 and 15 months.with the majority of adverse events (AEs) being grade 1 or 2. The most common AEs were diarrhea (22.1%), contusion (20.6%), and constipation (14.7%). Atrial fibrillation/flutter was reported in two patients; one patient had grade 3 hypertension. No patient experienced major hemorrhage. In total, four patients discontinued treatment due to AEs, of which was considered treatment-related by the investigators. Conclusions: Zanubrutinib demonstrated high ORR and CR rate with durable disease control and a favorable safety profile in patients with R/R MZL.
    Citation
    Opat S, Tedeschi A, Linton K, McKay P, Hu B, Chan H, et al. The Magnolia Trial: Zanubrutinib, A Next-Generation Bruton Tyrosine Kinase Inhibitor, Demonstrates Safety and Efficacy in Relapsed/Refractory Marginal Zone Lymphoma. Clin Cancer Res. 2021 Sep 15;clincanres.1704.2021.
    Journal
    Clinical Cancer Research
    URI
    http://hdl.handle.net/10541/624653
    DOI
    10.1158/1078-0432.Ccr-21-1704
    PubMed ID
    34526366
    Additional Links
    https://dx.doi.org/10.1158/1078-0432.Ccr-21-1704
    Type
    Article
    Language
    en
    ae974a485f413a2113503eed53cd6c53
    10.1158/1078-0432.Ccr-21-1704
    Scopus Count
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