{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,10]],"date-time":"2026-09-10T03:04:46Z","timestamp":1789009486217,"version":"build-2803163510"},"reference-count":9,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2021,10,14]],"date-time":"2021-10-14T00:00:00Z","timestamp":1634169600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2021,10,14]],"date-time":"2021-10-14T00:00:00Z","timestamp":1634169600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"name":"This study was sponsored by BeiGene."}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["J Hematol Oncol"],"published-print":{"date-parts":[[2021,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Mantle cell lymphoma (MCL) is a mature B-cell neoplasm with a high initial response rate followed almost invariably by relapse. Here we report the pooled data from 2 studies, BGB-3111-AU-003 and BGB-3111-206, to explore the efficacy of zanubrutinib monotherapy in relapsed\/refractory (R\/R) MCL. A total of 112 patients were included. Median follow-up durations were 24.7 and 24.9\u00a0months for BGB-3111-AU-003 and BGB-3111-206, respectively. Overall response rate (ORR) and complete response (CR) rate were 84.8% and 62.5%, and median duration of response, progression-free survival (PFS) and overall survival (OS) were 24.9, 25.8 and 38.2\u00a0months, respectively. After weighting, the PFS (median: NE vs. 21.1\u00a0months,<jats:italic>P<\/jats:italic>\u2009=\u20090.235) and OS (median: NE vs. 38.2\u00a0months,<jats:italic>P<\/jats:italic>\u2009=\u20090.057) were similar but numerically better in the second-line than later-line group. Zanubrutinib was well-tolerated with treatment discontinuation and dose reduction for adverse events in 12.5% and 2.7% of patients, respectively. Hypertension, major hemorrhage and atrial fibrillation\/flutter rates were 11.6%, 5.4% and 1.8%, respectively. Zanubrutinib is efficacious in R\/R MCL, with a favorable safety profile.<\/jats:p>","DOI":"10.1186\/s13045-021-01174-3","type":"journal-article","created":{"date-parts":[[2021,10,14]],"date-time":"2021-10-14T14:52:04Z","timestamp":1634223124000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":34,"title":["Zanubrutinib monotherapy in relapsed\/refractory mantle cell lymphoma: a pooled analysis of two clinical trials"],"prefix":"10.1186","volume":"14","author":[{"given":"Keshu","family":"Zhou","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dehui","family":"Zou","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jianfeng","family":"Zhou","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jianda","family":"Hu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Haiyan","family":"Yang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Huilai","family":"Zhang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jie","family":"Ji","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wei","family":"Xu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jie","family":"Jin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fangfang","family":"Lv","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ru","family":"Feng","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sujun","family":"Gao","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daobin","family":"Zhou","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Constantine S.","family":"Tam","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Simpson","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Wang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tycel J.","family":"Phillips","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephen","family":"Opat","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhiyue","family":"Huang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Huafei","family":"Lu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuqin","family":"Song","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yongping","family":"Song","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2021,10,14]]},"reference":[{"key":"1174_CR1","doi-asserted-by":"publisher","first-page":"739","DOI":"10.1002\/ajh.24094","volume":"90","author":"JM Vose","year":"2015","unstructured":"Vose JM. Mantle cell lymphoma: 2015 update on diagnosis, risk-stratification, and clinical management. Am J Hematol. 2015;90:739\u201345.","journal-title":"Am J Hematol"},{"key":"1174_CR2","doi-asserted-by":"crossref","unstructured":"Dreyling M, Geisler C, Hermine O, Kluin-Nelemans HC, Le Gouill S, Rule S, et al. Newly diagnosed and relapsed mantle cell lymphoma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2014;25 Suppl 3:iii83\u201392.","DOI":"10.1093\/annonc\/mdu264"},{"key":"1174_CR3","doi-asserted-by":"publisher","first-page":"589","DOI":"10.1038\/s41571-020-0414-y","volume":"17","author":"G Li","year":"2020","unstructured":"Li G, Liu X, Chen X. Simultaneous development of zanubrutinib in the USA and China. Nat Rev Clin Oncol. 2020;17:589\u201390.","journal-title":"Nat Rev Clin Oncol"},{"key":"1174_CR4","doi-asserted-by":"publisher","first-page":"520","DOI":"10.1093\/annonc\/mdn656","volume":"20","author":"A Goy","year":"2009","unstructured":"Goy A, Bernstein SH, Kahl BS, Djulbegovic B, Robertson MJ, de Vos S, et al. Bortezomib in patients with relapsed or refractory mantle cell lymphoma: updated time-to-event analyses of the multicenter phase 2 PINNACLE study. Ann Oncol. 2009;20:520\u20135.","journal-title":"Ann Oncol"},{"key":"1174_CR5","doi-asserted-by":"publisher","first-page":"3688","DOI":"10.1200\/JCO.2013.49.2835","volume":"31","author":"A Goy","year":"2013","unstructured":"Goy A, Sinha R, Williams ME, Kalayoglu Besisik S, Drach J, Ramchandren R, et al. Single-agent lenalidomide in patients with mantle-cell lymphoma who relapsed or progressed after or were refractory to bortezomib: phase II MCL-001 (EMERGE) study. J Clin Oncol. 2013;31:3688\u201395.","journal-title":"J Clin Oncol"},{"key":"1174_CR6","doi-asserted-by":"publisher","first-page":"3822","DOI":"10.1200\/JCO.2008.20.7977","volume":"27","author":"G Hess","year":"2009","unstructured":"Hess G, Herbrecht R, Romaguera J, Verhoef G, Crump M, Gisselbrecht C, et al. Phase III study to evaluate temsirolimus compared with investigator\u2019s choice therapy for the treatment of relapsed or refractory mantle cell lymphoma. J Clin Oncol. 2009;27:3822\u20139.","journal-title":"J Clin Oncol"},{"key":"1174_CR7","doi-asserted-by":"publisher","first-page":"7923","DOI":"10.1021\/acs.jmedchem.9b00687","volume":"62","author":"Y Guo","year":"2019","unstructured":"Guo Y, Liu Y, Hu N, Yu D, Zhou C, Shi G, et al. Discovery of Zanubrutinib (BGB-3111), a Novel, Potent, and Selective Covalent Inhibitor of Bruton\u2019s Tyrosine Kinase. J Med Chem. 2019;62:7923\u201340.","journal-title":"J Med Chem"},{"key":"1174_CR8","doi-asserted-by":"publisher","first-page":"851","DOI":"10.1182\/blood.2019001160","volume":"134","author":"CS Tam","year":"2019","unstructured":"Tam CS, Trotman J, Opat S, Burger JA, Cull G, Gottlieb D, et al. Phase 1 study of the selective BTK inhibitor zanubrutinib in B-cell malignancies and safety and efficacy evaluation in CLL. Blood. 2019;134:851\u20139.","journal-title":"Blood"},{"key":"1174_CR9","doi-asserted-by":"publisher","first-page":"4216","DOI":"10.1158\/1078-0432.CCR-19-3703","volume":"26","author":"Y Song","year":"2020","unstructured":"Song Y, Zhou K, Zou D, Zhou J, Hu J, Yang H, et al. Treatment of patients with relapsed or refractory mantle-cell lymphoma with Zanubrutinib, a selective inhibitor of Bruton\u2019s tyrosine kinase. Clin Cancer Res. 2020;26:4216\u201324.","journal-title":"Clin Cancer Res"}],"container-title":["Journal of Hematology &amp; Oncology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s13045-021-01174-3.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1186\/s13045-021-01174-3\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s13045-021-01174-3.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,1,12]],"date-time":"2023-01-12T08:18:22Z","timestamp":1673511502000},"score":1,"resource":{"primary":{"URL":"https:\/\/jhoonline.biomedcentral.com\/articles\/10.1186\/s13045-021-01174-3"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,10,14]]},"references-count":9,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2021,12]]}},"alternative-id":["1174"],"URL":"https:\/\/doi.org\/10.1186\/s13045-021-01174-3","relation":{},"ISSN":["1756-8722"],"issn-type":[{"value":"1756-8722","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,10,14]]},"assertion":[{"value":"7 August 2021","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"22 September 2021","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"14 October 2021","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"All methods were performed in accordance with the relevant guidelines and regulations.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The authors declare that they have no competing interests.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"167"}}