{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,13]],"date-time":"2026-07-13T13:12:21Z","timestamp":1783948341615,"version":"3.55.0"},"reference-count":35,"publisher":"American Society of Hematology","issue":"23","content-domain":{"domain":["ashpublications.org"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2020,12,8]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:p>Patients with Waldenstr\u00f6m macroglobulinemia (WM) lacking activating mutations in the MYD88 gene (MYD88WT) have demonstrated relatively poor outcomes to ibrutinib monotherapy, with no major responses reported in a phase 2 pivotal study. Zanubrutinib is a novel, selective Bruton tyrosine kinase (BTK) inhibitor designed to maximize BTK occupancy and minimize off-target activity. The ASPEN study consisted of a randomized comparison of zanubrutinib and ibrutinib efficacy and safety in patients with WM who have the MYD88 mutation, as well as a separate cohort of patients without MYD88 mutation (MYD88WT) or with unknown mutational status who received zanubrutinib. Results from the latter single-arm cohort are reported herein. Efficacy endpoints included overall, major and complete (CR) or very good partial response (VGPR) rates, progression-free survival (PFS), duration of response (DOR), and overall survival (OS). Twenty-eight patients (23 relapsed\/refractory; 5 treatment-na\u00efve) were enrolled, including 26 with centrally confirmed MYD88WT disease and 2 with unknown MYD88 mutational status. At a median follow-up of 17.9 months, 7 of 26 MYD88WT patients (27%) had achieved a VGPR and 50% a major response (partial response or better); there were no CRs. At 18 months, the estimated PFS and OS rates were 68% and 88%, respectively, while the median DOR had not been reached. Two patients discontinued zanubrutinib due to adverse events. Treatment-emergent hypertension, atrial fibrillation, and major hemorrhages were reported in 3, 1 and 2 patients (including 1 concurrent with enoxaparin therapy), respectively. Results of this substudy demonstrate that zanubrutinib monotherapy can induce high quality responses in patients with MYD88WT WM. This trial is registered on www.clinicaltrials.gov as NCT #03053440.<\/jats:p>","DOI":"10.1182\/bloodadvances.2020003010","type":"journal-article","created":{"date-parts":[[2020,12,9]],"date-time":"2020-12-09T05:33:11Z","timestamp":1607491991000},"page":"6009-6018","update-policy":"https:\/\/doi.org\/10.1182\/blood.2019cm0000","source":"Crossref","is-referenced-by-count":76,"title":["Zanubrutinib for the treatment of MYD88 wild-type Waldenstr\u00f6m macroglobulinemia: a substudy of the phase 3 ASPEN trial"],"prefix":"10.1182","volume":"4","author":[{"given":"Meletios","family":"Dimopoulos","sequence":"first","affiliation":[{"name":"Department of Clinical Therapeutics, National and Kapodistrian University of Athens, Athens, Greece;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4120-2787","authenticated-orcid":false,"given":"Ramon Garcia","family":"Sanz","sequence":"additional","affiliation":[{"name":"Hospital Universitario de Salamanca, Salamanca, Spain;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hui-Peng","family":"Lee","sequence":"additional","affiliation":[{"name":"Department of Haematology, Flinders Medical Centre, Adelaide, SA, Australia;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6952-6073","authenticated-orcid":false,"given":"Marek","family":"Trneny","sequence":"additional","affiliation":[{"name":"1st Department of Medicine, Faculty of Medicine 1, Charles University, General Hospital, Prague, Czech Republic;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marzia","family":"Varettoni","sequence":"additional","affiliation":[{"name":"Fondazione Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Policlinico, San Matteo, Pavia, Italy;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephen","family":"Opat","sequence":"additional","affiliation":[{"name":"Monash Health and"},{"name":"Department of 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Australia;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jaroslaw","family":"Czyz","sequence":"additional","affiliation":[{"name":"Szpital Uniwersytecki nr 2, Dr Jana Biziela, Kujawsko-pomorskie, Bydgoszcz, Poland;"},{"name":"Department of Hematology, Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University in Toru\u0144, Bydgoszcz, Poland;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9490-7532","authenticated-orcid":false,"given":"Jorge J.","family":"Castillo","sequence":"additional","affiliation":[{"name":"Bing Center for Waldenstr\u00f6m Macroglobulinemia, Dana-Farber Cancer Institute, Boston, MA;"},{"name":"Medical Oncology, Harvard Medical School, Boston, MA;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marina","family":"Motta","sequence":"additional","affiliation":[{"name":"AO Spedali Civili di Brescia, Lombardia, Italy;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tanya","family":"Siddiqi","sequence":"additional","affiliation":[{"name":"City of Hope National Medical Center, Duarte, CA;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8106-8909","authenticated-orcid":false,"given":"Mercedes","family":"Gironella Mesa","sequence":"additional","affiliation":[{"name":"Hospital Universitario Vall d'Hebr\u00f3n, Barcelona, Spain;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0366-3673","authenticated-orcid":false,"given":"Miquel","family":"Granell Gorrochategui","sequence":"additional","affiliation":[{"name":"Hospital de La Santa Creu i Sant Pau, Barcelona, Spain;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6766-8345","authenticated-orcid":false,"given":"Dipti","family":"Talaulikar","sequence":"additional","affiliation":[{"name":"The John Curtin School of Medical Research, Australian National University, Canberra, ACT, Australia;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pier Luigi","family":"Zinzani","sequence":"additional","affiliation":[{"name":"Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy;"},{"name":"Istituto di Ematologia \u201cSer\u00e0gnoli,\u201d Dipartimento di Medicina Specialistica, Diagnostica e Sperimentale Universit\u00e0 degli Studi, Bologna, Italy;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elham","family":"Askari","sequence":"additional","affiliation":[{"name":"Hospital Universitario Fundaci\u00f3n Jim\u00e9nez D\u00edaz, Madrid, Spain;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sebastian","family":"Grosicki","sequence":"additional","affiliation":[{"name":"Department of Hematology and Cancer Prevention, Health Sciences Faculty, Medical University of Silesia, Katowice, 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