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dc.contributor.authorOpat, Stephen S-
dc.contributor.authorTedeschi, Alessandra-
dc.contributor.authorHu, Bei-
dc.contributor.authorLinton, Kim M-
dc.contributor.authorMcKay, Pamela-
dc.contributor.authorLeitch, Sophie-
dc.contributor.authorColeman, Morton-
dc.contributor.authorZinzani, Pier Luigi-
dc.contributor.authorJin, Jie-
dc.contributor.authorSun, Mingyuan-
dc.contributor.authorSobieraj-Teague, Magdalena-
dc.contributor.authorBrowett, Peter J-
dc.contributor.authorKe, Xiaoyan-
dc.contributor.authorThieblemont, Catherine-
dc.contributor.authorArdeshna, Kirit M-
dc.contributor.authorBijou, Fontanet-
dc.contributor.authorWalker, Patricia A-
dc.contributor.authorHawkes, Eliza A-
dc.contributor.authorHo, Shir-Jing-
dc.contributor.authorZhou, Keshu-
dc.contributor.authorLiang, Zhiyu-
dc.contributor.authorXu, Jianfeng-
dc.contributor.authorTankersley, Chris-
dc.contributor.authorDelarue, Richard-
dc.contributor.authorCo, Melannie-
dc.contributor.authorTrotman, Judith-
dc.identifier.citationBlood Advances 2023-11-28; 7(22)en_US
dc.description.abstractThe 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.en_US
dc.titleSafety and efficacy of zanubrutinib in relapsed/refractory marginal zone lymphoma: final analysis of the MAGNOLIA study.en_US
dc.typeJournal Articleen_US
dc.identifier.journaltitleBlood Advancesen_US
dc.identifier.affiliationMonash Health, Clayton, Australia.en_US
dc.identifier.affiliationASST Grande Ospedale Metropolitano Niguarda, Niguarda Cancer Center, Milano, Italy.en_US
dc.identifier.affiliationAtrium Health Levine Cancer Institute, Charlotte, North Carolina, United States.en_US
dc.identifier.affiliationThe Manchester Cancer Research Centre, Manchester, United Kingdom.en_US
dc.identifier.affiliationBeatson West of Scotland Cancer Centre, Glasgow, United Kingdom.en_US
dc.identifier.affiliationNorth Shore Hospital, Auckland, New Zealand.en_US
dc.identifier.affiliationClinical Reliance Alliance, Lake Success, New York, United States.en_US
dc.identifier.affiliationUniversity of Bologna, Bologna, Italy.en_US
dc.identifier.affiliationFirst Affiliated Hospital of Zhejiang University College of Medicine, Hangzhou, China.en_US
dc.identifier.affiliationnstitute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Tianjin, China.en_US
dc.identifier.affiliationFlinders Medical Centre, Bedford Park, Australia.en_US
dc.identifier.affiliationThe University of Auckland, Auckland, New Zealand.en_US
dc.identifier.affiliationPeking University Third Hospital.en_US
dc.identifier.affiliationAP-HP, Hôpital Saint-Louis, Hemato-oncologie, DMU DHI,F-75010 Paris, France, Paris, France.en_US
dc.identifier.affiliationUCLH, London, United Kingdom.en_US
dc.identifier.affiliationInstitut Bergonie, Bordeaux, France.en_US
dc.identifier.affiliationPeninsula Health, PARKDALE, VI, Australia.en_US
dc.identifier.affiliationOlivia Newton-John Cancer Research Instituteen_US
dc.identifier.affiliationSt George Hospital, Kogarah, Australia.en_US
dc.identifier.affiliationHenan Cancer Hospital, Zhengzhou, China, Zhengzhou, China.en_US
dc.identifier.affiliationBeiGene, Shanghai, China.en_US
dc.identifier.affiliationBeiGene, Ridgefield Park, New Jersey, United States.en_US
dc.identifier.affiliationBeigene, San Mateo, California, United States.en_US
dc.identifier.affiliationBeiGene Switzerland GmbH, Basel, Switzerland.en_US
dc.identifier.affiliationBeigene, San Mateo, California, United States.en_US
dc.identifier.affiliationConcord Repatriation General Hospital and University of Sydney, Concord, United Kingdom.en_US
item.fulltextNo Fulltext-
item.openairetypeJournal Article-
item.languageiso639-1en- Haematology- Newton-John Cancer Wellness and Research Centre- Newton-John Cancer Research Institute-
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