{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,24]],"date-time":"2026-09-24T12:09:04Z","timestamp":1790251744251,"version":"4.1.0"},"reference-count":32,"publisher":"Springer Science and Business Media LLC","issue":"10","license":[{"start":{"date-parts":[[2026,7,17]],"date-time":"2026-07-17T00:00:00Z","timestamp":1784246400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2026,7,17]],"date-time":"2026-07-17T00:00:00Z","timestamp":1784246400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"name":"Autolus Therapeutics PLC"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Leukemia"],"published-print":{"date-parts":[[2026,10]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>\n                    In the single-arm Phase Ib\/II FELIX study (NCT04404660), obecabtagene autoleucel (obe-cel; CD19-directed autologous CAR T-cell therapy) demonstrated high overall remission rates (ORR) and a\u00a0favorable safety profile in adults with relapsed\/refractory (R\/R) B-cell acute lymphoblastic leukemia (B-ALL). To contextualize results from FELIX, we compared the efficacy and safety of obe-cel with matched external control arms (ECA) derived from historical trials using propensity score matching. ECAs represented standard of care (SoC) non-CAR T-cell therapies: blinatumomab, inotuzumab ozogamicin, and conventional chemotherapy. The primary endpoint was ORR; secondary endpoints included overall survival (OS). Event-free survival (EFS) and safety were exploratory endpoints. Among the intent-to-treat population in FELIX (\n                    <jats:italic>n<\/jats:italic>\n                    \u2009=\u2009107), obe-cel demonstrated significantly higher ORR than non-CAR T-cell therapies (67.3% vs 51.4%; odds ratio 1.9;\n                    <jats:italic>p<\/jats:italic>\n                    \u2009=\u20090.0257). Median OS was longer with obe-cel when censoring for hematopoietic stem cell transplant (15.1 vs 7.0 months;\n                    <jats:italic>p<\/jats:italic>\n                    \u2009=\u20090.0015) and without censoring (13.9 vs 7.8 months;\n                    <jats:italic>p<\/jats:italic>\n                    \u2009=\u20090.0430). EFS was significantly improved with obe-cel (median 9.8 vs 2.5 months;\n                    <jats:italic>p<\/jats:italic>\n                    \u2009&lt;\u20090.0001). Safety profiles were comparable between groups, with similar rates of Grade \u22653 adverse events. Obe-cel offers superior remission rates and survival benefits over current SoC non-CAR T-cell therapies, with an acceptable safety profile; its use could address unmet needs in adult R\/R B-ALL.\n                  <\/jats:p>","DOI":"10.1038\/s41375-026-03045-7","type":"journal-article","created":{"date-parts":[[2026,7,17]],"date-time":"2026-07-17T06:40:51Z","timestamp":1784270451000},"page":"2181-2190","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Comparison of obecabtagene autoleucel versus an external control arm in adult patients with relapsed\/refractory B-cell acute lymphoblastic leukemia"],"prefix":"10.1038","volume":"40","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1267-5289","authenticated-orcid":false,"given":"Max S.","family":"Topp","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4328-6021","authenticated-orcid":false,"given":"Bijal D.","family":"Shah","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4465-6119","authenticated-orcid":false,"given":"Elias","family":"Jabbour","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2903-5130","authenticated-orcid":false,"given":"Jae H.","family":"Park","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul","family":"Shaughnessy","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1179-5879","authenticated-orcid":false,"given":"Aaron C.","family":"Logan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karamjeet S.","family":"Sandhu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mehrdad","family":"Abedi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael R.","family":"Bishop","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7865-2306","authenticated-orcid":false,"given":"Daniel J.","family":"DeAngelo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0135-3196","authenticated-orcid":false,"given":"Xiang","family":"Yin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2650-5384","authenticated-orcid":false,"given":"Ruthanna","family":"Davi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katharine","family":"Hodby","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ram","family":"Malladi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0000-8537-0577","authenticated-orcid":false,"given":"Wolfram","family":"Brugger","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Justin","family":"Shang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Claire","family":"Roddie","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1908-3307","authenticated-orcid":false,"given":"Hagop M.","family":"Kantarjian","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,7,17]]},"reference":[{"key":"3045_CR1","doi-asserted-by":"publisher","first-page":"938","DOI":"10.1111\/ejh.14405","volume":"114","author":"A Bruzzese","year":"2025","unstructured":"Bruzzese A, Martino EA, Labanca C, Carid\u00e0 G, Mendicino F, Lucia E, et al. Therapeutic strategies for relapsed or refractory B-cell acute lymphoblastic leukemia in adult patients: optimizing the use of monoclonal antibodies. Eur J Haematol. 2025;114:938\u201352.","journal-title":"Eur J Haematol"},{"key":"3045_CR2","doi-asserted-by":"publisher","first-page":"779","DOI":"10.3390\/cancers17050779","volume":"17","author":"CM Csizmar","year":"2025","unstructured":"Csizmar CM, Litzow MR, Saliba AN. Antibody-based and other novel agents in adult B-cell acute lymphoblastic leukemia. Cancers (Basel). 2025;17:779.","journal-title":"Cancers (Basel)"},{"key":"3045_CR3","doi-asserted-by":"publisher","first-page":"1524","DOI":"10.3324\/haematol.2016.144311","volume":"101","author":"N G\u00f6kbuget","year":"2016","unstructured":"G\u00f6kbuget N, Dombret H, Ribera JM, Fielding AK, Advani A, Bassan R, et al. International reference analysis of outcomes in adults with B-precursor Ph-negative relapsed\/refractory acute lymphoblastic leukemia. Haematologica. 2016;101:1524\u201333.","journal-title":"Haematologica"},{"key":"3045_CR4","doi-asserted-by":"publisher","first-page":"2763","DOI":"10.1182\/bloodadvances.2024014846","volume":"9","author":"H Lust","year":"2025","unstructured":"Lust H, Schultz LM, Kwon S, Roloff GW, Aldoss I, Baggott C, et al. Real-world outcomes for young adult patients receiving CD19 CAR T-cell therapy. Blood Adv. 2025;9:2763\u201372.","journal-title":"Blood Adv"},{"key":"3045_CR5","doi-asserted-by":"publisher","first-page":"1903","DOI":"10.1182\/blood.2023023568","volume":"143","author":"N G\u00f6kbuget","year":"2024","unstructured":"G\u00f6kbuget N, Boissel N, Chiaretti S, Dombret H, Doubek M, Fielding A, et al. Management of ALL in adults: 2024 ELN recommendations from a European expert panel. 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FDA approves brexucabtagene autoleucel for relapsed or refractory B-cell precursor acute lymphoblastic leukemia 2021 [Available from: https:\/\/www.fda.gov\/drugs\/resources-information-approved-drugs\/fda-approves-brexucabtagene-autoleucel-relapsed-or-refractory-b-cell-precursor-acute-lymphoblastic]."},{"key":"3045_CR11","unstructured":"European Medicines Agency. Tecartus 2020 [Available from: https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/tecartus]."},{"key":"3045_CR12","unstructured":"Medicines & Healthcare Products Regulatory Agency. Brexucabtagene Autoleucel SmPC (revised 01\/2026) 2023 [Available from: https:\/\/products.mhra.gov.uk\/search\/?search=brexucabtagene+autoleucel&page=1]."},{"key":"3045_CR13","unstructured":"European Medicines Agency. Kymriah 2018 [Available from: https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/kymriah]."},{"key":"3045_CR14","unstructured":"Medicines & Healthcare Products Regulatory Agency. 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Leukemia. 2025;39:1058\u201368.","journal-title":"Leukemia"},{"key":"3045_CR17","doi-asserted-by":"publisher","first-page":"1408","DOI":"10.1038\/s41591-019-0549-5","volume":"25","author":"S Ghorashian","year":"2019","unstructured":"Ghorashian S, Kramer AM, Onuoha S, Wright G, Bartram J, Richardson R, et al. Enhanced CAR T cell expansion and prolonged persistence in pediatric patients with ALL treated with a low-affinity CD19 CAR. Nat Med. 2019;25:1408\u201314.","journal-title":"Nat Med"},{"key":"3045_CR18","doi-asserted-by":"publisher","first-page":"2219","DOI":"10.1056\/NEJMoa2406526","volume":"391","author":"C Roddie","year":"2024","unstructured":"Roddie C, Sandhu KS, Tholouli E, Logan AC, Shaughnessy P, Barba P, et al. Obecabtagene autoleucel in adults with B-cell acute lymphoblastic leukemia. N Engl J Med. 2024;391:2219\u201330.","journal-title":"N Engl J Med"},{"key":"3045_CR19","unstructured":"U.S. Food & Drug Administration. Obecabtagene autoleucel Prescribing Information (revised 02\/2026) 2024 [Available from: https:\/\/www.fda.gov\/media\/183463\/download?attachment]."},{"key":"3045_CR20","unstructured":"European Medicines Agency. Obecabtagene Autoleucel SmPC (revised 08\/2025) 2025 [Available from: https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/aucatzyl]."},{"key":"3045_CR21","unstructured":"Medicines & Healthcare Products Regulatory Agency. Obecabtagene Autoleucel SmPC (revised 01\/2026) 2025 [Available from: https:\/\/products.mhra.gov.uk\/search\/?search=obecabtagene+autoleucel&page=1]."},{"key":"3045_CR22","doi-asserted-by":"publisher","first-page":"3352","DOI":"10.1200\/JCO.21.00917","volume":"39","author":"C Roddie","year":"2021","unstructured":"Roddie C, Dias J, O\u2019Reilly MA, Abbasian M, Cadinanos-Garai A, Vispute K, et al. Durable responses and low toxicity after fast off-rate CD19 chimeric antigen receptor-T therapy in adults with relapsed or refractory B-cell acute lymphoblastic leukemia. J Clin Oncol. 2021;39:3352\u201363.","journal-title":"J Clin Oncol"},{"key":"3045_CR23","volume":"9","author":"JH Park","year":"2025","unstructured":"Park JH, Roddie C, Tholouli E, Sandhu KS, Shaughnessy P, Barba P, et al. Can CAR T-cell therapy be a definitive treatment for adult R\/R B-ALL without transplant? Long-term findings and predictors of sustained remission for obecabtagene autoleucel [abstract]. HemaSphere. 2025;9:e70151.","journal-title":"HemaSphere"},{"key":"3045_CR24","doi-asserted-by":"publisher","DOI":"10.1002\/cam4.7447","volume":"13","author":"E Farah","year":"2024","unstructured":"Farah E, Kenney M, Warkentin MT, Cheung WY, Brenner DR. Examining external control arms in oncology: a scoping review of applications to date. 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Am J Hematol. 2025;100:1205\u201331.","journal-title":"Am J Hematol"}],"container-title":["Leukemia"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.nature.com\/articles\/s41375-026-03045-7.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/www.nature.com\/articles\/s41375-026-03045-7","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/www.nature.com\/articles\/s41375-026-03045-7.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,9,24]],"date-time":"2026-09-24T11:43:24Z","timestamp":1790250204000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.nature.com\/articles\/s41375-026-03045-7"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,7,17]]},"references-count":32,"journal-issue":{"issue":"10","published-print":{"date-parts":[[2026,10]]}},"alternative-id":["3045"],"URL":"https:\/\/doi.org\/10.1038\/s41375-026-03045-7","relation":{},"ISSN":["0887-6924","1476-5551"],"issn-type":[{"value":"0887-6924","type":"print"},{"value":"1476-5551","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,7,17]]},"assertion":[{"value":"19 November 2025","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"18 May 2026","order":2,"name":"revised","label":"Revised","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"24 June 2026","order":3,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"17 July 2026","order":4,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"MST: Advisory role or expert testimony from AbbVie, AstraZeneca, Autolus Therapeutics, Incyte, Kite\/Gilead Sciences, Regeneron; financing of scientific research from AstraZeneca, Kite\/Gilead Sciences, Regeneron, and F. Hoffmann-La Roche Ltd. BDS: Consulting fees from Adaptive, Amgen, AstraZeneca, Autolus Therapeutics, BeiGene, Bristol Myers Squibb, Century Therapeutics, Deciphera, Gilead Sciences, Jazz Pharmaceuticals, Kite, Lilly, Pepromene Bio, Pfizer, Precision Biosciences, Novartis, and Takeda; research funding from Jazz Pharmaceuticals, Gilead Sciences, Kite, and Servier. EJ: Consulting fees from AbbVie, Adaptive Biotechnologies, Amgen, Ascentage, Astellas Pharma, Autolus Therapeutics, Daiichi-Sankyo, Genentech, Inc., Hikma, Kite, Novartis, Pfizer, Rigel Pharmaceuticals Inc., Takeda, TargetRx, and TERN Pharmaceuticals; research funding from AbbVie, Adaptive Biotechnologies, Amgen, Ascentage, Astex, Autolus Therapeutics, Bristol Myers Squibb, Kite, Novartis, Pfizer, Takeda, TargetRx, and TERN Pharmaceuticals. JHP: Consulting fees from Adaptive Biotechnologies, Affyimmune, Allogene, Amgen, Artiva Biotherapeutics, Autolus Therapeutics, Bright Pharmaceutical Services, Bristol Myers Squibb, Caribou Biosciences, Curocell, Galapagos, Gilead Sciences, Intellia, Kite, Novartis, Pfizer, Servier, Sobi, Synthekine, and Takeda; research funding from Autolus Therapeutics, Fate Therapeutics, Genentech, Inc., InCyte, Servier, Sobi, and Takeda; personal fees from Curocell. PS: Consulting fees from Autolus Therapeutics and Sanofi; honoraria from Bristol Myers Squibb and Sanofi. ACL: Consulting fees from Actinium, Amgen, Kite, Pfizer, Sanofi, and Takeda; research funding from Amgen, Astellas Pharma, Autolus Therapeutics, Gilead Sciences, Pharmacyclics, Sanofi, and Talaris. KSS: Consulting fees from Autolus Therapeutics. MA: Consulting fees from Autolus Therapeutics and Bristol Myers Squibb; research funding from Autolus Therapeutics, Bristol Myers Squibb, and Gilead Sciences; honoraria from AbbVie, Bristol Myers Squibb, and Gilead Sciences; personal fees from CytoDyn. MRB: Consulting fees from Achieve Clinics, Arcellx, Autolus Therapeutics, Bristol Myers Squibb, Chimeric Therapeutics, CRISPR Therapeutics, In8Bio, Iovance Biotherapeutics, Kite, Optum Health, Novartis, and Sana Biotechnology; research funding from Arcellx, Autolus Therapeutics, Bristol Myers Squibb, CRISPR Therapeutics, Gilead Sciences, Lyell, and Novartis; honoraria from AbbVie, ADC Therapeutics, Bristol Myers Squibb, Gilead Sciences, Incyte, Novartis, Sanofi, and Servier; personal fees from Achieve Clinics and In8Bio. DJD: Consulting fees from Amgen, Autolus Therapeutics, Blueprint Medicines, Gilead Sciences, InCyte, Jazz Pharmaceuticals, Novartis, Pfizer, Servier, and Takeda; research funding from AbbVie, Blueprint Medicines, GlycoMimetics, and Novartis; honoraria from Daiichi-Sankyo, and Mt Sinai MPN Consortium. XY: Employment\/leadership position and stocks from Medidata Solutions, a Dassault Syst\u00e8mes company. RD: Employment\/leadership position and stocks from Medidata Solutions, a Dassault Syst\u00e8mes company. KH: Consulting fees from Autolus Therapeutics. RM: Employee of Autolus Therapeutics. WB: Employee of and personal fees from Autolus Therapeutics. JS: Employee of and personal fees from Autolus Therapeutics. CR: Consulting fees from Autolus Therapeutics, Bristol Myers Squibb, Gilead Sciences, and Janssen; honoraria from Autolus Therapeutics, Bristol Myers Squibb, and Gilead Sciences. HMK: Advisory role or expert testimony from AbbVie, Amgen, Ascentage Pharma, Ipsen, Biopharmaceuticals, KAHR Medical, Novartis, Pfizer, Shenzhen Target Rx, Stemline, and Takeda. All authors received nonfinancial support (assistance with manuscript preparation) from Ashfield MedComms, which received funding from Autolus Therapeutics.","order":1,"name":"Ethics","label":"Competing interests","group":{"name":"EthicsHeading","label":"Ethics"}},{"value":"The FELIX study received central ethics approval from the following country-level ethics committee (EC)\/institutional review board (IRB): West London & GTAC Research EC (reference number: 19\/LO\/1949; UK), WIRB-Copernicus Group IRB (reference number: 20200446; US*), and Clinical Research Ethics Committee Hospital Universitari Vall d\u2019Hebron (VHIR) (reference number: 2024-512903-38-00\n                      \u2020\n                      ; Spain). All patients in the FELIX study provided written informed consent. All methods were performed in accordance with the relevant guidelines and regulations. No identifiable images from human research participants appear in this article. The external control arm was derived from data from previously conducted clinical trials accessed through Medidata data-sharing agreements. *While some US sites were able to utilize the central IRB, some sites had their own local IRBs with corresponding approvals.\n                      \u2020\n                      Original EudraCT reference number was 2019-001937-16.","order":2,"name":"Ethics","label":"Ethics approval and consent to participate","group":{"name":"EthicsHeading","label":"Ethics"}}]}}