{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,9]],"date-time":"2026-11-09T23:14:46Z","timestamp":1794266086540,"version":"4.9.0"},"reference-count":37,"publisher":"Springer Science and Business Media LLC","issue":"4","license":[{"start":{"date-parts":[[2022,3,21]],"date-time":"2022-03-21T00:00:00Z","timestamp":1647820800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2022,3,21]],"date-time":"2022-03-21T00:00:00Z","timestamp":1647820800000},"content-version":"vor","delay-in-days":0,"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":["Nat Med"],"published-print":{"date-parts":[[2022,4]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>\n                    High-risk large B-cell lymphoma (LBCL) has poor outcomes with standard first-line chemoimmunotherapy. In the phase\u20092, multicenter, single-arm ZUMA-12 study (ClinicalTrials.gov NCT03761056) we evaluated axicabtagene ciloleucel (axi-cel), an autologous anti-CD19 chimeric antigen receptor (CAR) T-cell therapy, as part of first-line treatment in 40\u2009patients with high-risk LBCL. This trial has completed accrual. The primary outcome was complete response rate (CRR). Secondary outcomes were objective response rate (ORR), duration of response (DOR), event-free survival (EFS), progression-free survival (PFS), overall survival (OS), assessment of safety, central nervous system (CNS) relapse and blood levels of CAR T\u2009cells and cytokines. The primary endpoint in efficacy-evaluable patients (\n                    <jats:italic>n<\/jats:italic>\n                    \u2009=\u200937) was met, with 78% CRR (95% confidence interval (CI), 62\u201390) and 89% ORR (95% CI, 75\u201397). As of 17\u2009May 2021 (median follow-up, 15.9\u2009months), 73% of patients remained in objective response; median DOR, EFS and PFS were not reached. Grade\u2009\u22653 cytokine release syndrome (CRS) and neurologic events occurred in three patients (8%) and nine patients (23%), respectively. There were no treatment-related grade\u20095 events. Robust CAR T-cell expansion occurred in all patients with a median time to peak of 8\u2009days. We conclude that axi-cel is highly effective as part of first-line therapy for high-risk LBCL, with a manageable safety profile.\n                  <\/jats:p>","DOI":"10.1038\/s41591-022-01731-4","type":"journal-article","created":{"date-parts":[[2022,3,21]],"date-time":"2022-03-21T13:02:59Z","timestamp":1647867779000},"page":"735-742","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":278,"title":["Axicabtagene ciloleucel as first-line therapy in high-risk large B-cell lymphoma: the phase 2 ZUMA-12 trial"],"prefix":"10.1038","volume":"28","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1045-4914","authenticated-orcid":false,"given":"Sattva S.","family":"Neelapu","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1492-5966","authenticated-orcid":false,"given":"Michael","family":"Dickinson","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Javier","family":"Munoz","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matthew L.","family":"Ulrickson","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9941-2448","authenticated-orcid":false,"given":"Catherine","family":"Thieblemont","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Olalekan O.","family":"Oluwole","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alex F.","family":"Herrera","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chaitra S.","family":"Ujjani","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yi","family":"Lin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter A.","family":"Riedell","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Natasha","family":"Kekre","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sven","family":"de Vos","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christine","family":"Lui","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francesca","family":"Milletti","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jinghui","family":"Dong","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hairong","family":"Xu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Julio C.","family":"Chavez","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2022,3,21]]},"reference":[{"key":"1731_CR1","unstructured":"WHO Classification of Tumours of Haematopoietic and Lymphoid Tissue 4th edn (World Health Organization, 2008)."},{"key":"1731_CR2","doi-asserted-by":"publisher","first-page":"842","DOI":"10.1056\/NEJMra2027612","volume":"384","author":"LH Sehn","year":"2021","unstructured":"Sehn, L. H. & Salles, G. Diffuse large B-cell lymphoma. New Engl. J. Med. 384, 842\u2013858 (2021).","journal-title":"New Engl. J. Med."},{"key":"1731_CR3","doi-asserted-by":"publisher","first-page":"2373","DOI":"10.1200\/JCO.2009.26.2493","volume":"28","author":"M Ziepert","year":"2010","unstructured":"Ziepert, M. et al. Standard International Prognostic Index remains a valid predictor of outcome for patients with aggressive CD20+ B-cell lymphoma in the rituximab era. J. Clin. Oncol. 28, 2373\u20132380 (2010).","journal-title":"J. Clin. Oncol."},{"key":"1731_CR4","doi-asserted-by":"publisher","first-page":"1857","DOI":"10.1182\/blood-2006-08-038257","volume":"109","author":"LH Sehn","year":"2007","unstructured":"Sehn, L. H. et al. The revised International Prognostic Index (R-IPI) is a better predictor of outcome than the standard IPI for patients with diffuse large B-cell lymphoma treated with R-CHOP. 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M.D., honoraria from Roche, Gilead, MSD and Novartis; consultancy or advisory role for Roche, Gilead, MSD and Novartis; speakers\u2019 bureau participation for Roche, Gilead, MSD and Novartis; and research funding from Novartis and Roche. J.M., honoraria from Targeted Oncology, OncView, Curio, Kyowa Kirin, Physicians\u2019 Education Resource and Seagen; consultancy or advisory role for Pharmacyclics\/AbbVie, Bayer, Kite, Pfizer, Janssen, Juno\/Celgene, Bristol Myers Squibb, Kyowa Kirin, Alexion, Fosun Kite, Innovent, Seagen, BeiGene, Debiopharm, Epizyme, Karyopharm, ADC Therapeutics, Servier and Genmab; speakers\u2019 bureau participation for Kite, Kyowa, Bayer, Pharmacyclics\/Janssen, Seagen, Acrotech\/Aurobindo, Beigene, Verastem, AstraZeneca, Celgene\/Bristol Myers Squibb and Genentech\/Roche; and research funding (payed to institution) from Bayer, Gilead\/Kite, Celgene, Merck, Portola, Incyte, Genentech, Pharmacyclics, Seagen, Janssen and Millennium. M.L.U., Advisory Board of Gilead and Stemline. C.T., honoraria from Bristol Myers Squibb\/Celgene, AbbVie, Takeda, Novartis, Roche, Kite, and Incyte; consultancy or advisory role for Bristol Myers Squibb\/Celgene, AbbVie, Takeda, Roche, Novartis, Kite, and Incyte; and travel support from Bristol Myers Squibb\/Celgene, Takeda, Roche, Novartis, and Kite. O.O.O., consultancy or advisory role for Kite, Janssen, Pfizer, Novartis and Curio Science; honoraria and research funding from Kite. A.F.H., consultancy or advisory role for Bristol Meyers Squibb, Merck, Genentech, Seagen, AstraZeneca, Karyopharm, ADC Therapeutics, Takeda and Tubulis; and research funding from Bristol Myers Squibb, Merck, Genentech, Seagen, Kite, Gilead Sciences, AstraZeneca, Karyopharm and ADC Therapeutics. C.S.U., consultancy or advisory role for Atara and Kite; research funding and travel expenses from Kite. Y.L., consultancy or advisory role for Kite, Janssen, Novartis, Celgene, Bluebird Bio, Juno, Legend, Sorrento, Gamida Cell and Vineti; and research funding from Kite, Janssen, Celgene, Bluebird Bio, Merck and Takeda. P.A.R., honoraria from Novartis; consultancy or advisory role for Novartis, Celgene\/Bristol Myers Squibb, Takeda, BeiGene and Karyopharm Therapeutics; speakers\u2019 bureau participation for Kite; and research funding from Kite, Celgene\/Bristol Myers Squibb, Novartis, Calibr, Xencor, MorphoSys and Tessa Therapeutics. N.K., consulting or advisory role and honoraria from Gilead, Novartis and Celgene. S.d.V., participation on a Data Safety Advisory Board for BeiGene. C.L., employment with and travel support from Kite; stock or other ownership in Gilead Sciences. F.M., employment with Kite; and stock or other ownership in Gilead. J.D., employment with Kite; stock or other ownership in Gilead Sciences; consultancy or advisory role for and intellectual property from GliaCure\/Tufts. H.X., employment with Kite. J.C.C., consultancy fees for Kite, AbbVie, Janssen, ADC Therapeutics, Karyopharm, Kymera, GenMab and Novartis; speakers\u2019 bureau participation for Morphosys, Epyzime, Bristol Myers Squibb, BeiGene and AstraZeneca; and research funding from AstraZeneca, Merck, ADC Therapeutics and Adaptive.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}]}}