{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,5]],"date-time":"2026-10-05T21:00:42Z","timestamp":1791234042157,"version":"4.1.0"},"reference-count":18,"publisher":"Wiley","issue":"11","license":[{"start":{"date-parts":[[2023,8,30]],"date-time":"2023-08-30T00:00:00Z","timestamp":1693353600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["American J Hematol"],"published-print":{"date-parts":[[2023,11]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Marginal zone lymphoma (MZL) is an indolent type of non\u2010Hodgkin lymphoma that develops through pathological B cell receptor signaling. Orelabrutinib, a new\u2010generation oral small molecule Bruton's tyrosine kinase inhibitor, was evaluated in relapsed\/refractory (r\/r) MZL patients. Previously treated r\/r MZL patients received orelabrutinib 150\u2009mg once daily in a phase 2, multicenter, single\u2010arm study conducted in China. The primary endpoint was overall response rate (ORR) assessed by an Independent Review Committee (IRC) based on the Lugano 2014 classification. Other efficacy, safety, and pharmacokinetic profiles were evaluated as secondary outcome measures. A total of 111 patients were enrolled, of which 90 patients had MZL confirmed by central pathology review, who were mainly with extra\u2010nodal MZL of mucosa\u2010associated lymphoid tissue (MALT, 46.7%) and nodal MZL (35.6%). The majority had late\u2010stage disease, with stage IV accounting for 75.6%. After a median follow\u2010up duration of 24.3\u2009months, the IRC\u2010assessed ORR was 58.9% (95% confidence interval [CI], 48.0\u201369.2), with rates of complete response and partial response being 11.1% and 47.8%, respectively. The IRC\u2010assessed median duration of response was 34.3\u2009months, and the IRC\u2010assessed median progression\u2010free survival (PFS) was not reached with a 12\u2010month PFS rate of 82.8% (95% CI, 72.6\u201389.5). The rate of overall survival at 12\u2009months was 91.0% (95% CI, 82.8\u201395.4). Common all\u2010grade treatment\u2010related adverse events (TRAEs) included anemia (27.9%), neutrophil count decrease (23.4%), white blood cell count decrease (18.0%), platelet count decrease (17.1%), blood present in urine (16.2%), rash (14.4%), and upper respiratory tract infection (10.8%). Thirty\u2010four patients (30.6%) experienced grade 3 or higher TRAEs. Serious TRAEs occurred in 18 patients (16.2%), of which pneumonia (5.4%) was the most common. Seven patients (6.3%) discontinued orelabrutinib due to TRAEs. Orelabrutinib demonstrated high response rates with durable disease remission and was well tolerated in Chinese patients with r\/r MZL.<\/jats:p>","DOI":"10.1002\/ajh.27064","type":"journal-article","created":{"date-parts":[[2023,8,30]],"date-time":"2023-08-30T15:44:26Z","timestamp":1693410266000},"page":"1742-1750","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":21,"title":["Orelabrutinib for the treatment of relapsed or refractory marginal zone lymphoma: A phase 2, multicenter, open\u2010label study"],"prefix":"10.1002","volume":"98","author":[{"given":"Lijuan","family":"Deng","sequence":"first","affiliation":[{"name":"Department of Lymphoma, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education) Peking University Cancer Hospital &amp; Institute  Beijing 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