The Magnolia Trial: Zanubrutinib, a next-generation bruton tyrosine kinase inhibitor, demonstrates safety and efficacy in relapsed/refractory marginal zone lymphoma
Opat, S. Tedeschi, A. Linton, Kim M McKay, P. Hu, B. Chan, H. Jin, J. Sobieraj-Teague, M. Zinzani, P. L. Coleman, M.
Opat, S.
Tedeschi, A.
Linton, Kim M
McKay, P.
Hu, B.
Chan, H.
Jin, J.
Sobieraj-Teague, M.
Zinzani, P. L.
Coleman, M.
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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.
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.
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.
Description
Date
2021
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Article
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.