{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,6]],"date-time":"2026-11-06T22:05:54Z","timestamp":1794002754556,"version":"4.8.0"},"reference-count":17,"publisher":"BMJ","issue":"8","license":[{"start":{"date-parts":[[2023,8,30]],"date-time":"2023-08-30T00:00:00Z","timestamp":1693353600000},"content-version":"unspecified","delay-in-days":29,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Kite, a Gilead Company","award":["N\/A"],"award-info":[{"award-number":["N\/A"]}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["J Immunother Cancer"],"accepted":{"date-parts":[[2023,6,18]]},"published-print":{"date-parts":[[2023,8]]},"abstract":"<jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>Brexucabtagene autoleucel (brexu-cel) is an autologous anti-CD19 chimeric antigen receptor (CAR) T-cell therapy approved in the USA for adults with relapsed or refractory (R\/R) B-cell acute lymphoblastic leukemia (B-ALL) and in the European Union for patients \u226526 years with R\/R B-ALL. After 2 years of follow-up in ZUMA-3, the overall complete remission (CR) rate (CR+CR with incomplete hematological recovery (CRi)) was 73%, and the median overall survival (OS) was 25.4 months in 78 Phase 1 and 2 patients with R\/R B-ALL who received the pivotal dose of brexu-cel. Outcomes by prior therapies and subsequent allogeneic stem cell transplantation (alloSCT) are reported.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Eligible adults had R\/R B-ALL and received one infusion of brexu-cel (1\u00d710\u2076 CAR T cells\/kg) following conditioning chemotherapy. The primary endpoint was the CR\/CRi rate per central review. Post hoc subgroup analyses were exploratory with descriptive statistics provided.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Phase 1 and 2 patients (N=78) were included with median follow-up of 29.7 months (range, 20.7\u201358.3). High CR\/CRi rates were observed across all prior therapy subgroups examined: 1 prior line of therapy (87%, n=15) and \u22652 prior lines (70%, n=63); prior blinatumomab (63%, n=38) and no prior blinatumomab (83%, n=40); prior inotuzumab (59%, n=17) and no prior inotuzumab (77%, n=61); and prior alloSCT (76%, n=29) and no prior alloSCT (71%, n=49). The frequency of Grade \u22653 cytokine release syndrome, neurological events, and treatment-related Grade 5 adverse events were largely similar among prior therapy subgroups.<\/jats:p>\n                  <jats:p>Median duration of remission (DOR) in responders with (n=14) and without (n=43) subsequent alloSCT was 44.2 (95% CI, 8.1 to not estimable (NE)) and 18.6 months (95% CI, 9.4 to NE); median OS was 47.0 months (95% CI, 10.2 to NE) and not reached (95% CI, 23.2 to NE), respectively. Median DOR and OS were not reached in responders without prior or subsequent alloSCT (n=22).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>In ZUMA-3, adults with R\/R B-ALL benefited from brexu-cel, regardless of prior therapies and subsequent alloSCT status, though survival appeared better in patients without certain prior therapies and in earlier lines of therapy. Additional studies are needed to determine the impact prior therapies and subsequent alloSCT have on outcomes of patients who receive brexu-cel.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1136\/jitc-2023-007118","type":"journal-article","created":{"date-parts":[[2023,8,30]],"date-time":"2023-08-30T12:06:09Z","timestamp":1693397169000},"page":"e007118","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":34,"title":["Impact of prior therapies and subsequent transplantation on outcomes in adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia treated with brexucabtagene autoleucel in ZUMA-3"],"prefix":"10.1136","volume":"11","clinical-trial-number":[{"clinical-trial-number":"nct02614066","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct02614066","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4328-6021","authenticated-orcid":false,"given":"Bijal D","family":"Shah","sequence":"first","affiliation":[{"name":"Division of Hematology\/Oncology, Department of Malignant Hematology, Moffitt Cancer Center, Tampa, Florida, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3424-2425","authenticated-orcid":false,"given":"Ryan D","family":"Cassaday","sequence":"additional","affiliation":[{"name":"Fred Hutchinson Cancer Center, University of Washington, Seattle, Washington, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jae H","family":"Park","sequence":"additional","affiliation":[{"name":"Department of Medicine, Memorial Hospital, Memorial Sloan Kettering Cancer Center, New York, New York, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Roch","family":"Houot","sequence":"additional","affiliation":[{"name":"Department of Hematology, CHU Rennes, University Hospital Rennes, Inserm & EFS, Rennes, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Olalekan O","family":"Oluwole","sequence":"additional","affiliation":[{"name":"Vanderbilt-Ingram Cancer Center, Division of Hematology and Oncology, Vanderbilt University, Nashville, Tennessee, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aaron C","family":"Logan","sequence":"additional","affiliation":[{"name":"Helen Diller Comprehensive Cancer Center, University of California San Francisco, San Francisco, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicolas","family":"Boissel","sequence":"additional","affiliation":[{"name":"D\u00e9partement d'H\u00e9matologie Clinique, H\u00f4pital Saint-Louis, Paris, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thibaut","family":"Leguay","sequence":"additional","affiliation":[{"name":"Department of Hematology, Service d'h\u00e9matologie clinique et th\u00e9rapie cellulaire H\u00f4pital du Haut-Leveque CHU de Bordeaux, Bordeaux, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael R","family":"Bishop","sequence":"additional","affiliation":[{"name":"The David and Etta Jonas Center for Cellular Therapy, The University of Chicago Medicine, Chicago, Illinois, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Max S","family":"Topp","sequence":"additional","affiliation":[{"name":"Medizinische Klinik und Poliklinik II, Universit\u00e4tsklinikum W\u00fcrzburg, Wurzburg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dimitrios","family":"Tzachanis","sequence":"additional","affiliation":[{"name":"Moores Cancer Center, University of California San Diego, San Diego, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kristen M","family":"O'Dwyer","sequence":"additional","affiliation":[{"name":"Wilmot Cancer Institute, University of Rochester, Rochester, New York, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martha L","family":"Arellano","sequence":"additional","affiliation":[{"name":"Winship Cancer Institute, Emory University, Atlanta, Georgia, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yi","family":"Lin","sequence":"additional","affiliation":[{"name":"Department of Hematology, Mayo Clinic, Rochester, Minnesota, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria R","family":"Baer","sequence":"additional","affiliation":[{"name":"Marlene and Stewart Greenebaum Cancer Center, University of Maryland, Baltimore, Maryland, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gary J","family":"Schiller","sequence":"additional","affiliation":[{"name":"David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marion","family":"Subklewe","sequence":"additional","affiliation":[{"name":"Department of Medicine III, Ludwig-Maximilians-Universit\u00e4t M\u00fcnchen, Munich, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mehrdad","family":"Abedi","sequence":"additional","affiliation":[{"name":"Davis Comprehensive Cancer Center, University of California, Sacramento, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Monique C","family":"Minnema","sequence":"additional","affiliation":[{"name":"Department of Hematology, University Medical Centre Utrecht, Utrecht, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"William G","family":"Wierda","sequence":"additional","affiliation":[{"name":"Department of Hematopathology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel J","family":"DeAngelo","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patrick J","family":"Stiff","sequence":"additional","affiliation":[{"name":"Department of Hematology\/Oncology, Loyola University Medical Center, Maywood, Illinois, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Deepa","family":"Jeyakumar","sequence":"additional","affiliation":[{"name":"Chao Comprehensive Cancer Center, University of California Irvine Medical Center, Irvine, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daqin","family":"Mao","sequence":"additional","affiliation":[{"name":"Kite, a Gilead Company, Santa Monica, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sabina","family":"Adhikary","sequence":"additional","affiliation":[{"name":"Kite, a Gilead Company, Santa Monica, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lang","family":"Zhou","sequence":"additional","affiliation":[{"name":"Kite, a Gilead Company, Santa Monica, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Petra C","family":"Schuberth","sequence":"additional","affiliation":[{"name":"Kite, a Gilead Company, Santa Monica, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rita","family":"Damico Khalid","sequence":"additional","affiliation":[{"name":"Kite, a Gilead Company, Santa Monica, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Armin","family":"Ghobadia","sequence":"additional","affiliation":[{"name":"Division of Medical Oncology, Washington University School of Medicine in Saint Louis, St Louis, Missouri, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2023,8,30]]},"reference":[{"key":"2025100308210526000_11.8.e007118.1","doi-asserted-by":"publisher","DOI":"10.3324\/haematol.2016.144311"},{"key":"2025100308210526000_11.8.e007118.2","doi-asserted-by":"publisher","DOI":"10.1056\/nejmoa1609783"},{"key":"2025100308210526000_11.8.e007118.3","doi-asserted-by":"crossref","first-page":"2474","DOI":"10.1002\/cncr.32116","article-title":"Inotuzumab Ozogamicin versus standard of care in Relapsed or refractory acute Lymphoblastic leukemia: final report and long-term survival follow-up from the randomized, phase 3 INO-VATE study","volume":"125","author":"Kantarjian","year":"2019","journal-title":"Cancer"},{"key":"2025100308210526000_11.8.e007118.4","first-page":"255","article-title":"Allogeneic hematopoietic cell transplantation for Relapsed and refractory Philadelphia negative B cell ALL in the era of novel salvage therapies","volume":"27","author":"Aldoss","year":"2021","journal-title":"Transplant Cell Ther"},{"key":"2025100308210526000_11.8.e007118.5","unstructured":"Kite Pharma, Inc . TECARTUS\u00ae (brexucabtagene autoleucel) [prescribing information]. Santa Monica, CA, 2021."},{"key":"2025100308210526000_11.8.e007118.6","unstructured":"Kite Pharma EU B.V . TECARTUS\u00ae (autologous anti-CD19-transduced CD3+ cells) [Summary of Product Characteristics]. Hoofddorp, The Netherlands, 2021."},{"key":"2025100308210526000_11.8.e007118.7","doi-asserted-by":"crossref","DOI":"10.1186\/s13045-022-01379-0","article-title":"Two-year follow-up of KTE-X19 in patients with Relapsed or refractory adult B-cell acute Lymphoblastic leukemia in ZUMA-3 and its Contextualization with SCHOLAR-3, an external historical control study","volume":"15","author":"Shah","year":"2022","journal-title":"J Hematol Oncol"},{"key":"2025100308210526000_11.8.e007118.8","unstructured":"Myers RM , Taraseviciute A , Steinberg SM , et al . Blinatumomab Nonresponse and high-disease burden are associated with inferior outcomes after Cd19-CAR for B-ALL. 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Two-year follow-up of KTE-X19 in patients with Relapsed or refractory adult B-cell acute Lymphoblastic leukemia in ZUMA-3 and its Contextualization with SCHOLAR-3, an external historical control study. J Hematol Oncol 2022;15. doi:10.1186\/s13045-022-01379-0","DOI":"10.1186\/s13045-022-01379-0"},{"key":"2025100308210526000_11.8.e007118.14","doi-asserted-by":"crossref","DOI":"10.1182\/blood.V130.Suppl_1.888.888","article-title":"Phase 1 results of ZUMA-3: KTE-C19, an anti-Cd19 Chimeric antigen receptor (CAR) T cell therapy, in adult patients with Relapsed\/refractory acute Lymphoblastic leukemia (R\/R ALL)","volume":"130","author":"Shah","year":"2017","journal-title":"Blood"},{"key":"2025100308210526000_11.8.e007118.15","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(21)01222-8"},{"key":"2025100308210526000_11.8.e007118.16","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2014-05-552729"},{"key":"2025100308210526000_11.8.e007118.17","doi-asserted-by":"crossref","unstructured":"Topp MS , G\u00f6ckbuget N , Stein AS . Correction to lancet Oncol 2015; 16: 60, 61. safety and activity of Blinatumomab for adult patients with Relapsed or refractory B-precursor acute Lymphoblastic leukaemia: a multi-centre, single-arm, phase 2 study. Lancet Oncol 2015;16. doi:10.1016\/S1470-2045(15)70154-3","DOI":"10.1016\/S1470-2045(14)71170-2"}],"container-title":["Journal for ImmunoTherapy of Cancer"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/jitc-2023-007118","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,3]],"date-time":"2025-10-03T15:21:13Z","timestamp":1759504873000},"score":1,"resource":{"primary":{"URL":"https:\/\/jitc.bmj.com\/lookup\/doi\/10.1136\/jitc-2023-007118"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,8]]},"references-count":17,"journal-issue":{"issue":"8","published-online":{"date-parts":[[2023,8,30]]},"published-print":{"date-parts":[[2023,8]]}},"alternative-id":["10.1136\/jitc-2023-007118"],"URL":"https:\/\/doi.org\/10.1136\/jitc-2023-007118","relation":{},"ISSN":["2051-1426"],"issn-type":[{"value":"2051-1426","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,8]]}}}