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Title: Safety and efficacy of zanubrutinib in relapsed/refractory marginal zone lymphoma: final analysis of the MAGNOLIA study.
Austin Authors: Opat, Stephen S;Tedeschi, Alessandra;Hu, Bei;Linton, Kim M;McKay, Pamela;Leitch, Sophie;Coleman, Morton;Zinzani, Pier Luigi;Jin, Jie;Sun, Mingyuan;Sobieraj-Teague, Magdalena;Browett, Peter J;Ke, Xiaoyan;Thieblemont, Catherine;Ardeshna, Kirit M;Bijou, Fontanet;Walker, Patricia A;Hawkes, Eliza A ;Ho, Shir-Jing;Zhou, Keshu;Liang, Zhiyu;Xu, Jianfeng;Tankersley, Chris;Delarue, Richard;Co, Melannie;Trotman, Judith
Affiliation: Monash Health, Clayton, Australia.
ASST Grande Ospedale Metropolitano Niguarda, Niguarda Cancer Center, Milano, Italy.
Atrium Health Levine Cancer Institute, Charlotte, North Carolina, United States.
The Manchester Cancer Research Centre, Manchester, United Kingdom.
Beatson West of Scotland Cancer Centre, Glasgow, United Kingdom.
North Shore Hospital, Auckland, New Zealand.
Clinical Reliance Alliance, Lake Success, New York, United States.
University of Bologna, Bologna, Italy.
First Affiliated Hospital of Zhejiang University College of Medicine, Hangzhou, China.
nstitute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Tianjin, China.
Flinders Medical Centre, Bedford Park, Australia.
The University of Auckland, Auckland, New Zealand.
Peking University Third Hospital.
AP-HP, Hôpital Saint-Louis, Hemato-oncologie, DMU DHI,F-75010 Paris, France, Paris, France.
UCLH, London, United Kingdom.
Institut Bergonie, Bordeaux, France.
Peninsula Health, PARKDALE, VI, Australia.
Olivia Newton-John Cancer Research Institute
St George Hospital, Kogarah, Australia.
Henan Cancer Hospital, Zhengzhou, China, Zhengzhou, China.
BeiGene, Shanghai, China.
BeiGene, Ridgefield Park, New Jersey, United States.
Beigene, San Mateo, California, United States.
BeiGene Switzerland GmbH, Basel, Switzerland.
Beigene, San Mateo, California, United States.
Concord Repatriation General Hospital and University of Sydney, Concord, United Kingdom.
Issue Date: 28-Nov-2023
Date: 2023
Publication information: Blood Advances 2023-11-28; 7(22)
Abstract: The primary analysis of MAGNOLIA, an open-label, single-arm, multicenter, phase 2 study, demonstrated that the next-generation Bruton tyrosine kinase inhibitor zanubrutinib provided a high overall response rate (ORR) in patients with relapsed/refractory marginal zone lymphoma (R/R MZL), with a favorable safety/tolerability profile. Presented here is the final analysis of MAGNOLIA, performed to characterize the durability of response and longer-term safety and tolerability. Zanubrutinib (160 mg twice daily) was evaluated in 68 patients with R/R MZL who had received at least 1 anti-CD20-directed regimen. The primary endpoint was independent review committee (IRC)-assessed ORR. Secondary endpoints included investigator-assessed ORR, duration of response (DOR), progression-free survival (PFS), overall survival (OS), health-related quality of life, safety, and tolerability. With a median follow-up of 27.4 months, the IRC-assessed ORR was 68.2% (95% confidence interval [CI], 55.6%-79.1%), with a 24-month DOR event-free rate of 72.9% (95% CI, 54.4%-84.9%). PFS and OS at 24 months were 70.9% (95% CI, 57.2%-81.0%) and 85.9% (95% CI, 74.7%-92.4%), respectively. The zanubrutinib safety profile was consistent with the primary analysis, with no new safety signals observed. Atrial fibrillation/flutter (n = 2 [2.9%]) and hypertension (n = 3 [4.4%]) were uncommon. Neutropenia (n = 8 [11.8%]) was the most common grade ≥3 adverse event. In this final analysis of MAGNOLIA, zanubrutinib demonstrated sustained clinical responses beyond 2 years, with 73% of responders alive and progression-free. Zanubrutinib continued to demonstrate a favorable safety/tolerability profile with the additional time on treatment. This trial was registered at as #NCT03846427.
DOI: 10.1182/bloodadvances.2023010668
ORCID: 0000-0002-0308-6458
Journal: Blood Advances
PubMed URL: 37682792
ISSN: 2473-9537
Type: Journal Article
Appears in Collections:Journal articles

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