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Cited by 1,607CAR-T cell therapy researchLymphoma Diagnosis and TreatmentCutaneous lymphoproliferative disorders research

Axicabtagene Ciloleucel as Second-Line Therapy for Large B-Cell Lymphoma

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Locke, Frederick L., Miklos, David B., Jacobson, Caron A., Perales, Miguel-Angel, Kersten, Marie-José, Oluwole, Olalekan O., Ghobadi, Armin, Rapoport, Aaron P. +23 more·2022·New England Journal of Medicine
DOI 10.1056/nejmoa2116133
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Abstract

BACKGROUND: The prognosis of patients with early relapsed or refractory large B-cell lymphoma after the receipt of first-line chemoimmunotherapy is poor. METHODS: In this international, phase 3 trial, we randomly assigned, in a 1:1 ratio, patients with large B-cell lymphoma that was refractory to or had relapsed no more than 12 months after first-line chemoimmunotherapy to receive axicabtagene ciloleucel (axi-cel, an autologous anti-CD19 chimeric antigen receptor T-cell therapy) or standard care (two or three cycles of investigator-selected, protocol-defined chemoimmunotherapy, followed by high-dose chemotherapy with autologous stem-cell transplantation in patients with a response to the chemoimmunotherapy). The primary end point was event-free survival according to blinded central review. Key secondary end points were response and overall survival. Safety was also assessed. RESULTS: A total of 180 patients were randomly assigned to receive axi-cel and 179 to receive standard care. The primary end-point analysis of event-free survival showed that axi-cel therapy was superior to standard care. At a median follow-up of 24.9 months, the median event-free survival was 8.3 months in the axi-cel group and 2.0 months in the standard-care group, and the 24-month event-free survival was 41% and 16%, respectively (hazard ratio for event or death, 0.40; 95% confidence interval, 0.31 to 0.51; P<0.001). A response occurred in 83% of the patients in the axi-cel group and in 50% of those in the standard-care group (with a complete response in 65% and 32%, respectively). In an interim analysis, the estimated overall survival at 2 years was 61% in the axi-cel group and 52% in the standard-care group. Adverse events of grade 3 or higher occurred in 91% of the patients who received axi-cel and in 83% of those who received standard care. Among patients who received axi-cel, grade 3 or higher cytokine release syndrome occurred in 6% and grade 3 or higher neurologic events in 21%. No deaths related to cytokine release syndrome or neurologic events occurred. CONCLUSIONS: Axi-cel therapy led to significant improvements, as compared with standard care, in event-free survival and response, with the expected level of high-grade toxic effects. (Funded by Kite; ZUMA-7 ClinicalTrials.gov number, NCT03391466.).

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Crossref · 10.1056/nejmoa2116133

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  • CAR-T-cell therapy offers durable remission and markedly extends survival in patients with relapsed/refractory large B-cell lymphoma.

    “Chimeric antigen receptor (CAR)-T-cell therapy has emerged as a revolutionary treatment; specifically, it offers durable remission and markedly extends survival in patients with relapsed/refractory large B-cell lymphoma patients.”

    From The burdens, coping strategies, and unmet needs of family caregivers of Chinese patients with lymphoma receiving commercial CAR-T-cell therapy: A qualitative study (2026) · cites this paper as [7]

    The Efficacy results (p. 5) support sustained benefit with axi-cel in the trial’s patients with refractory or early-relapsed large B-cell lymphoma: 24-month event-free survival was 41% versus 16% with standard care. But the claim that it markedly extends survival overstates the reported overall-survival result: the interim difference did not reach statistical significance (p. 5; Discussion, p. 11). The trial also concerns second-line axi-cel specifically, not CAR-T-cell therapy generally. (LLM, conf=0.90)

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Research works printed but not linked: 2

  1. [9]9. therapy in refractory aggressive lymphoma. Mol Ther 2017; 25: 285-95.
  2. [24]24. Sehn LH, Salles G. Diffuse large B-cell lymphoma. N Engl J Med 2021; 384: 84258.

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Authors
Locke, F. L., Miklos, D. B., Jacobson, C. A., Perales, M.-A., Kersten, M.-J., Oluwole, O. O., Ghobadi, A., Rapoport, A. P., McGuirk, J., Pagel, J. M., Muñoz, J., Farooq, U., van Meerten, T., Reagan, P. M., Sureda, A., Flinn, I. W., Vandenberghe, P., Song, K. W., Dickinson, M., Minnema, M. C., Riedell, P. A., Leslie, L. A., Chaganti, S., Yang, Y., Filosto, S., Shah, J., Schupp, M., To, C., Cheng, P., Gordon, L. I., & Westin, J. R.
Affiliations
  • University Medical Center Groningen (NL)
  • From the H. Lee Moffitt Cancer Center, Tampa, FL (F.L.L.); Stanford University School of Medicine, Stanford (D.B.M.), and Kite, a Gilead company, Santa Monica (Y.Y., S.F., J.S., M.S., C.T., P.C.) — both in California; Dana–Farber Cancer Institute, Boston (C.A.J.); Memorial Sloan Kettering Cancer Center, New York (M.-A.P.), and the University of Rochester School of Medicine, Rochester (P.M.R.) — both in New York; Amsterdam Medical Center, University of Amsterdam, Cancer Center Amsterdam, Amsterdam (M.-J.K.), University Medical Center Groningen, Groningen (T.M.), and University Medical Center Utrecht, Utrecht (M.C.M.) — all in the Netherlands; Vanderbilt–Ingram Cancer Center (O.O.O.) and Sarah Cannon Research Institute and Tennessee Oncology (I.W.F.) — both in Nashville; Washington University School of Medicine, St. Louis (A.G.); the Marlene and Stewart Greenebaum Cancer Center, University of Maryland School of Medicine, Baltimore (A.P.R.); the University of Kansas Cancer Center, Kansas City (J. McGuirk); th...
ORCID
Venue
New England Journal of Medicine
Publisher
Massachusetts Medical Society
Published
2022-02-17
Volume
386
Issue
7
Pages
640-654
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
DOI
10.1056/nejmoa2116133
OpenAlex
W4200201081
Cited by
1,607
References
32
Citations by year
2026: 270 · 2025: 385 · 2024: 389 · 2023: 344 · 2022: 215 · 2021: 1 · 2013: 1
FWCI
86.52
Type
journal article
Language
en
Open access
Licence
Locations
  • New England Journal of Medicine (publishedVersion)
  • PubMed (publishedVersion)
  • EUR Research Repository (Erasmus University Rotterdam) (publishedVersion, other-oa)
  • University of Groningen research database (University of Groningen / Centre for Information Technology) (publishedVersion, other-oa)
  • Pure Amsterdam UMC (acceptedVersion, other-oa)
  • Digital Commons@Becker (Washington University School of Medicine) (submittedVersion)
  • Data Archiving and Networked Services (DANS) (submittedVersion)
  • EUR Research Repository (Erasmus University Rotterdam) (submittedVersion, other-oa)
  • Archivio istituzionale della ricerca (Alma Mater Studiorum Università di Bologna) (submittedVersion, other-oa)
  • Lirias (KU Leuven) (submittedVersion)
  • Amsterdam UMC (VU Amsterdam) - Institutional Repository (submittedVersion)
  • University of Groningen research database (University of Groningen / Centre for Information Technology) (submittedVersion, other-oa)
Funders
Kite, a Gilead company
Topics
  • Health Sciences › Medicine › Oncology › CAR-T cell therapy research
  • Health Sciences › Medicine › Pathology and Forensic Medicine › Lymphoma Diagnosis and Treatment
  • Health Sciences › Medicine › Dermatology › Cutaneous lymphoproliferative disorders research
Keywords
axicabtagene ciloleucel, CAR T-cell therapy, large B-cell lymphoma, relapsed/refractory lymphoma, second-line therapy, anti-CD19, event-free survival, overall survival, cytokine release syndrome, neurological adverse events, autologous stem cell transplantation, chemoimmunotherapy
MeSH terms
Antineoplastic Agents, Immunological, Receptors, Chimeric Antigen, Progression-Free Survival, Adult, Aged, Aged, 80 and over, Biological Products, Female, Humans, Male, Middle Aged, Transplantation, Autologous, Immunotherapy, Adoptive, Lymphoma, Large B-Cell, Diffuse, Drug Resistance, Neoplasm, Stem Cell Transplantation

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