@article{e2bdc26c6cc84e4c90acc8a9d65312fd,
title = "A Phase III study of zanubrutinib plus rituximab versus bendamustine plus rituximab in transplant-ineligible, untreated mantle cell lymphoma",
abstract = "Mantle cell lymphoma is an aggressive B-cell malignancy. Current frontline chemoimmunotherapies produce high response rates but relapse is inevitable. Furthermore, the elderly and those with comorbidities are precluded from standard regimens and stem cell transplant, leaving them with limited options. Targeted therapies, including Bruton tyrosine kinase inhibitors, are an effective treatment strategy in mantle cell lymphoma. Zanubrutinib is a potent next-generation Bruton tyrosine kinase inhibitor that has demonstrated complete and sustained Bruton tyrosine kinase occupancy, minimal off-target effects and favorable pharmacokinetic/pharmacodynamic properties. Described herein is an ongoing Phase III study comparing the efficacy and safety of zanubrutinib plus rituximab followed by zanubrutinib monotherapy versus bendamustine plus rituximab followed by observation in transplant-ineligible patients with previously untreated mantle cell lymphoma. Clinical Trial Registration: NCT04002297 (ClinicalTrials.gov.",
keywords = "Bruton tyrosine kinase, BTK inhibitor, clinical trial, mantle cell lymphoma, zanubrutinib",
author = "Martin Dreyling and Tam, {Constantine S.} and Michael Wang and Smith, {Stephen D.} and Marco Ladetto and Huiqiang Huang and William Novotny and Melannie Co and Alfredo Romano and Eric Holmgren and Jane Huang and Gouill, {Steven Le}",
note = "Funding Information: This clinical trial is supported by BeiGene USA, Inc., CA, USA. M Dreyling has received honoraria from Bayer, Celgene, Gilead, Janssen and Roche; served as consultant/advisor for Acerta, Bayer, Celgene, Gilead, Janssen, Novartis, Roche and Sandoz; and received research funding from Celgene, Janssen and Roche. CS Tam has served as consultant/advisor for BeiGene, Janssen, Roche, AbbVie and Loxo; and received research funding from Janssen, AbbVie, BeiGene, Pharmacyclics and TG Therapeutics. M Wang owns stock in MORE Health; has received honoraria from Pharmacyclics, Janssen, AstraZeneca, OMI, Targeted Oncology and OncLive; served as consultant/advisor for Pharmacyclics, Celgene, Janssen, AstraZeneca, MORE Health and Pulse; received research funding from Pharmacyclics, Janssen, AstraZeneca, Kite Pharma, Juno, Loxo Oncology, VelosBio and Celgene; and received travel/accommodation/expenses from Janssen, Pharmacyclics, Celgene, OMI, Kite Pharma and AstraZeneca. SD Smith has served as consultant/advisor for AstraZeneca and BeiGene; and received research funding from Acerta, AstraZeneca, Ayala (family member), Bristol Myers Squibb (family member), Genentech/Roche, Ignyta (family), Incyte, Merck Sharp & Dohme, Phar-macyclics, Portola, Seattle Genetics, De Novo Pharmaceuticals and BeiGene. M Ladetto has received honoraria, research funding, travel/accommodations/expenses and has served as a consultant/advisor for AbbVie, Acerta, Amgen, Archigen, Celgene, ADC Therapeutics, Gilead, Novartis, Johnson & Johnson, Roche, Roche Diagnostics, Sandoz, Takeda and BeiGene. H Huang has nothing to disclose. W Novotny is an employee of and owns stock in BeiGene. M Co is an employee of, owns stock in and received travel expenses from BeiGene. A Romano and E Holmgren are employees of and own stock in BeiGene. J Huang is an employee of, has a leadership role at and owns stock in BeiGene. S Le Gouill has received honoraria, travel/accommodations/expenses and has served as a consultant/advisor for AbbVie, Celgene, Gilead-Kite, Novartis, Janssen-Cilag, Roche, Roche Diagnostics, Servier, Daiichi Sankyo and Loxo. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. Publisher Copyright: {\textcopyright} 2021 Future Medicine Ltd.. All rights reserved.",
year = "2021",
month = jan,
doi = "10.2217/fon-2020-0794",
language = "English",
volume = "17",
pages = "255--262",
journal = "Future Oncology",
issn = "1479-6694",
publisher = "Future Medicine Ltd.",
number = "3",
}
