{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,23]],"date-time":"2026-10-23T23:22:25Z","timestamp":1792797745412,"version":"4.5.0"},"reference-count":20,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2026,4,27]],"date-time":"2026-04-27T00:00:00Z","timestamp":1777248000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2026,6,7]],"date-time":"2026-06-07T00:00:00Z","timestamp":1780790400000},"content-version":"vor","delay-in-days":41,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"name":"Kite, a Gilead Company"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["J Hematol Oncol"],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>\n                      Treatment with brexucabtagene autoleucel (brexu-cel), an autologous anti-CD19 chimeric antigen receptor (CAR) T-cell therapy, demonstrated a high objective response rate (93%) and complete response rate (67%) in 60 patients with relapsed\/refractory mantle cell lymphoma (R\/R MCL) treated in the pivotal ZUMA-2 Cohort 1 study. Subsequently, brexu-cel was approved in the United States and European Union for the treatment of adults with R\/R MCL (after \u2265\u20092 prior therapies in the European Union). Here we report 5-year outcomes from the pivotal ZUMA-2 Cohort 1 study (\n                      <jats:italic>N<\/jats:italic>\n                      \u2009=\u200968), as well as two previously unpublished ZUMA-2 data sets, long-term outcomes in 10 patients who received axi-cel in Cohort 1 and in 14 patients who received a lower dose of brexu-cel in Cohort 2.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      The primary endpoint for all cohorts of ZUMA-2 was objective response rate. Key secondary endpoints included duration of response (DOR), overall survival (OS), and safety. Patients could transition to a long-term follow-up study after 24 months for monitoring of survival and select adverse events possibly related to brexu-cel. Patients in Cohort 1 received a single infusion of 2\u2009\u00d7\u200910\n                      <jats:sup>6<\/jats:sup>\n                      anti-CD19 CAR T cells\/kg (axi-cel or brexu-cel). Patients in Cohort 2 received 0.5\u2009\u00d7\u200910\n                      <jats:sup>6<\/jats:sup>\n                      anti-CD19 CAR T cells\/kg (brexu-cel).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Median follow-up for the pivotal cohort (\n                      <jats:italic>N<\/jats:italic>\n                      \u2009=\u200968) was 67.8 months (range, 58.2\u201388.6) with a median DOR of 36.5 months (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200960), per investigator review. Median OS was 46.5 months (95% CI, 24.5\u201360.2;\n                      <jats:italic>N<\/jats:italic>\n                      \u2009=\u200968) and was 60.2 months (95% CI, 42.8-not estimable) in patients with complete response (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200946). The 5-year incidence of cumulative relapse-related and non-relapse\u2013related mortality was 40% (24\/60) and 22% (13\/60) in responders, respectively. Descriptive outcomes for axi-cel\u2013treated patients (\n                      <jats:italic>N<\/jats:italic>\n                      \u2009=\u200910) and Cohort 2 (\n                      <jats:italic>N<\/jats:italic>\n                      \u2009=\u200914) are reported herein. No Grade 5 cytokine-release syndrome or neurologic events, subsequent T-cell malignancies, or new safety signals were reported in any patient.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Patients in ZUMA-2 continued to have durable responses after 5 years of follow-up with predictable long-term safety, supporting the continued use of brexu-cel in R\/R MCL. Interpretations of outcomes in axi-cel\u2013treated patients and Cohort 2 are not feasible due to small patient numbers and unmatched baseline characteristics.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration<\/jats:title>\n                    <jats:p>NCT02601313 and NCT05041309.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1186\/s13045-026-01797-4","type":"journal-article","created":{"date-parts":[[2026,4,27]],"date-time":"2026-04-27T02:25:11Z","timestamp":1777256711000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Five-year follow-up of patients with relapsed\/refractory mantle cell lymphoma treated with anti-CD19 CAR T-cell therapy in ZUMA-2, Cohorts 1 and 2"],"prefix":"10.1186","volume":"19","author":[{"given":"Javier","family":"Mu\u00f1oz","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Frederick L.","family":"Locke","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patrick M.","family":"Reagan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andre","family":"Goy","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Caron A.","family":"Jacobson","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brian T.","family":"Hill","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John M.","family":"Timmerman","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ian W.","family":"Flinn","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David B.","family":"Miklos","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John M.","family":"Pagel","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marie Jos\u00e9","family":"Kersten","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Edouard","family":"Forcade","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Max S.","family":"Topp","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Roch","family":"Houot","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amer","family":"Beitinjaneh","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dan","family":"Zheng","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mengru","family":"Chang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wangshu","family":"Zhang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rhine R.","family":"Shen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rita Damico","family":"Khalid","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ioana","family":"Kloos","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael L.","family":"Wang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,4,27]]},"reference":[{"key":"1797_CR1","unstructured":"TECARTUS. 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PMR reports consulting\/advisory role for Kite, a Gilead Company; and research funding from Genentech and Seagen. AG reports employment with Regional Cancer Care Associates, OMI; leadership role with COTA Healthcare and Genomics Testing Cooperative LLC; stock or other ownership in Alloplex, COTA, Genomics Testing Cooperative LLC, and Resilience; consulting\/advisory role for AbbVie, Clinical Advances in Hematology & Oncology, Janssen Biotech, Janssen Global Services LLC, Kite, a Gilead Company, Medscape, Michael J. Hennessey, Novartis, and Pharmacyclics LLC, an AbbVie Company; research funding to institution from Acerta, AstraZeneca, Bristol Myers Squibb, Celgene, Genentech, Infinity, Janssen, Karyopharm, Kite, MorphoSys, Pharmacyclics, Seagen, and Verastem; travel support from Physicians Education Resource, LLC; and other relationships with Alloplex, AstraZeneca, Bristol Myers Squibb, Janssen Biotech Inc, Pharmacyclics LLC, an AbbVie Company (steering committee), and Vincerx (advisory board). FLL reports honoraria from Aptitude Health, ASH, BioPharma, Communications CARE Education, Clinical Care Options Oncology, IMedeX Society for Immunotherapy of Cancer; consulting\/advisory role for A2 Bio, Allogene, Amgen, bluebird bio, BMS, Calibr, Caribou, Cowen, EcoR1, Gerson Lehrman Group (GLG), Iovance, Kite, a Gilead Company, Janssen, Legend Biotech, Novartis, Sana, Umoja, Pfizer; research funding from Kite Pharma (Institutional), Allogene (Institutional), CERo Therapeutics (Institutional), Novartis (Institutional), bluebird bio (Institutional), 2seventy bio (Institutional), BMS (Institutional), National Cancer Institute (R01CA244328 MPI: Locke; P30CA076292 PI: Cleveland), Leukemia and Lymphoma Society Scholar in Clinical Research (PI: Locke); patents, royalties, or other intellectual property from Moffitt Cancer Center; and travel support from ASH, Kite Pharma. CAJ reports consulting\/advisory role for AbbVie, Abintus Bio, ADC Therapeutics, Bristol Myers Squibb\/Celgene, Caribou Biosciences, Daiichi Sankyo, ImmPACT Bio, Instil Bio, Ipsen, Kite, a Gilead Company, Miltenyi Biotec, MorphoSys, Novartis, and Synthekine; and research funding from Kite and Pfizer. BTH reports honoraria from consulting\/advisory role for, research funding from, and travel support from Kite, a Gilead Company. JMT reports consulting\/advisory role for Sobi; and research funding from Cargo Therapeutics, Kite, a Gilead Company, Merck, and Regeneron. IWF reports consultancy\/advisory role (paid to Sarah Cannon Research Institute until 8\/31\/23; 8\/31\/23-current, paid to Dr. Ian Flinn) for AbbVie, BeiGene, Genentech, Genmab, Kite, a Gilead Company, Roche, and Vincerx Pharma; and research funding (2022-2024 paid to Sarah Cannon Research Institute) from AbbVie, Acerta Pharma, Agios, ArQule, AstraZeneca, BeiGene, Biopath, Bristol Myers Squibb, CALIBR, CALGB, Celgene, City of Hope National Medical Center, Constellation Pharmaceuticals, Curis, CTI Biopharma, Epizyme, Fate Therapeutics, Forma Therapeutics, Forty Seven, Genentech, Gilead Sciences, InnoCare Pharma, IGM Biosciences, Incyte, Infinity Pharmaceuticals, Janssen, Kite, Loxo, Marker Therapeutics, Merck, Millennium Pharmaceuticals, MorphoSys, Myeloid Therapeutics, Novartis, Nurix, Pfizer, Pharmacyclics, Portola Pharmaceuticals, Rhizen Pharmaceuticals, Roche, Seagen, Step Pharma, Tessa Therapeutics, TG Therapeutics, Trillium Therapeutics, Triphase Research & Development Corp., Unum Therapeutics, Verastem, Vincerx Pharma, and 2seventy bio. DBM reports honoraria from Fosun Kite Biotechnology; consulting\/advisory role for Bristol Myers Squibb, Galapagos, Miltenyi Biotec, and Novartis; research funding from Adaptive biotechnologies, Adicet, Allogene, Kite, a Gilead Company, and 2seventy bio; patents, royalties, or other intellectual property from Janssen (No financial renumeration); and travel support from Kite, a Gilead Company. JMP reports consulting\/advisory role for Actinium, AstraZeneca, Epizyme, Kite, a Gilead Company, and MorphoSys\/Incyte. MJK reports ihonoraria from and consulting\/advisory role for Adicet Bio, Bristol Myers Squibb\/Celgene, Kite, a Gilead Company, Miltenyi Biotec, Novartis, and Roche; research funding from Kite (to institution); and travel support from Kite, Miltenyi Biotec, Novartis, and Roche. EF reports consulting or advisory role for Novartis and MaaT Pharma; speaker\u2019s bureau participation for Alexion, Astellas, Gilead Sciences, GlaxoSmithKline, Jazz, Novartis, Sanofi and Sobi; and travel support from Alexion, Gilead Sciences, Novartis and Sanofi. MST reports consulting\/advisory role for AbbVie, AstraZeneca, Autolus, Bristol Myers Squibb, Incyte, Janssen and Kite, a Gilead Company; research funding from AstraZeneca, Regeneron and Roche; and travel support from BeiGene and Kite. RH reports honoraria from ADC Therapeutics, Bristol Myers Squibb, Celgene, Gilead Sciences, Janssen, Kite, a Gilead Company, MSD, and Novartis; and consulting\/advisory role for Kite and Gilead Sciences. AB reports consulting\/advisory role for Autolus Therapeutics; and research funding from Atara, Autolus, CRISPOR, Kite, a Gilead Company, Lyell and Tessa. DZ reports employment with, stock in, and honoraria and travel support from Kite, a Gilead Company. MC reports employment with Kite, a Gilead Company; and stock or other ownership in BeyondSpring Pharmaceuticals, Inc. WZ reports employment with Kite, a Gilead Company. RDK reports employment with, stock or other ownership in, and travel support from Kite, a Gilead Company. IK reports employment with Kite, a Gilead Company. RRS reports employment with Kite, a Gilead Company; stock or other ownership in Gilead Sciences; and patents, royalties and other intellectual property from Atara and Kite. MW reports honoraria from AbbVie, Acerta Pharma, AstraZeneca, BeiGene, BioInvent, Bristol Myers Squibb, CAHON, Catamount Medical Education, Dava Oncology, Genmab, Janssen, Kite, a Gilead Company, MJH Life Sciences, Merck, MSC National Research Institute of Oncology, NIH, Nurix, Pharmacyclics, Physicians Education Resources (PER), Research to Practice, Scripps, Studio ER Congressi, South African Clinical Hematology Society and WebMD; consulting\/advisory role for AbbVie, Acerta Pharma, ADC Therapeutics America, Amphista Therapeutics Limited, AstraZeneca, BeiGene, Be Biopharma, BioInvent, Bristol Myers Squibb, Deciphera, Genentech, InnoCare, Janssen, Kite Pharma, Lilly, Merck, Miltenyi Biomedicine, Oncternal, Parexel, PeproMene Bio, and Pharmacyclics; and research funding from Acerta Pharma, AstraZeneca, BeiGene, BioInvent, Celgene, Genmab, Genentech, InnoCare, Janssen, Juno Therapeutics, Kite Pharma, Lilly, Loxo Oncology, Molecular Templates, Oncternal, Pharmacyclics, and Vincerx.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"39"}}