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Three-year follow-up analysis of axicabtagene ciloleucel in relapsed/refractory indolent non-Hodgkin lymphoma (ZUMA-5).

  • Neelapu, Sattva S1
  • Chavez, Julio C2
  • Sehgal, Alison R3
  • Epperla, Narendranath4
  • Ulrickson, Matthew5
  • Bachy, Emmanuel6
  • Munshi, Pashna N7
  • Casulo, Carla8
  • Maloney, David G9
  • de Vos, Sven10
  • Reshef, Ran11
  • Leslie, Lori A12
  • Oluwole, Olalekan O13
  • Yakoub-Agha, Ibrahim14
  • Khanal, Rashmi15
  • Rosenblatt, Joseph16
  • Korn, Ronald17
  • Peng, Weixin18
  • Lui, Christine18
  • Wulff, Jacob18
  • And 6 more
  • 1 Department of Lymphoma and Myeloma, The University of Texas MD Anderson Cancer Center, Houston, TX.
  • 2 Moffitt Cancer Center and Research Institute, Tampa, FL.
  • 3 University of Pittsburgh Medical Center Hillman Cancer Center, Pittsburgh, PA.
  • 4 The Ohio State University Comprehensive Cancer Center, Columbus, OH.
  • 5 Banner MD Anderson Cancer Center, Gilbert, AZ.
  • 6 Centre Hospitalier Lyon Sud, Pierre-Bénite, France. , (France)
  • 7 Georgetown Lombardi Comprehensive Cancer Center, Washington, DC.
  • 8 Wilmot Cancer Center, University of Rochester Medical Center, Rochester, NY.
  • 9 Fred Hutchinson Cancer Research Center, Seattle, WA.
  • 10 Ronald Reagan University of California Los Angeles Medical Center, Santa Monica, CA.
  • 11 Columbia University Herbert Irving Comprehensive Cancer Center, New York City, NY.
  • 12 John Theurer Cancer Center, Hackensack Meridian Health, Hackensack, NJ.
  • 13 Vanderbilt University Medical Center, Nashville, TN.
  • 14 INSERM U1286, Infinite, Centre Hospitalier Universitaire de Lille, Lille, France. , (France)
  • 15 Fox Chase Cancer Center, Philadelphia, PA.
  • 16 University of Miami Sylvester Comprehensive Cancer Center, Miami, FL.
  • 17 Imaging Endpoints, Scottsdale, AZ.
  • 18 Kite, a Gilead company, Santa Monica, CA.
  • 19 Dana-Farber Cancer Institute, Boston, MA.
Published Article
American Society of Hematology
Publication Date
Feb 08, 2024
DOI: 10.1182/blood.2023021243
PMID: 37879047


Axicabtagene ciloleucel (axi-cel) is an autologous anti-CD19 chimeric antigen receptor (CAR) T-cell therapy approved for relapsed/refractory (R/R) follicular lymphoma (FL). Approval was supported by the phase 2, multicenter, single-arm ZUMA-5 study of axi-cel for patients with R/R indolent non-Hodgkin lymphoma (iNHL; N = 104), including FL and marginal zone lymphoma (MZL). In the primary analysis (median follow-up, 17.5 months), the overall response rate (ORR) was 92% (complete response rate, 74%). Here, we report long-term outcomes from ZUMA-5. Eligible patients with R/R iNHL after ≥2 lines of therapy underwent leukapheresis, followed by lymphodepleting chemotherapy and axi-cel infusion (2 × 106 CAR T cells per kg). The primary end point was ORR, assessed in this analysis by investigators in all enrolled patients (intent-to-treat). After median follow-up of 41.7 months in FL (n = 127) and 31.8 months in MZL (n = 31), ORR was comparable with that of the primary analysis (FL, 94%; MZL, 77%). Median progression-free survival was 40.2 months in FL and not reached in MZL. Medians of overall survival were not reached in either disease type. Grade ≥3 adverse events of interest that occurred after the prior analyses were largely in recently treated patients. Clinical and pharmacokinetic outcomes correlated negatively with recent exposure to bendamustine and high metabolic tumor volume. After 3 years of follow-up in ZUMA-5, axi-cel demonstrated continued durable responses, with very few relapses beyond 2 years, and manageable safety in patients with R/R iNHL. The ZUMA-5 study was registered at as #NCT03105336. © 2024 American Society of Hematology. Published by Elsevier Inc. Licensed under Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0), permitting only noncommercial, nonderivative use with attribution. All other rights reserved.

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