Survival with axicabtagene ciloleucel in large B-cell lymphoma Journal Article


Authors: Westin, J. R.; Oluwole, O. O.; Kersten, M. J.; Miklos, D. B.; Perales, M. A.; Ghobadi, A.; Rapoport, A. P.; Sureda, A.; Jacobson, C. A.; Farooq, U.; van Meerten, T.; Ulrickson, M.; Elsawy, M.; Leslie, L. A.; Chaganti, S.; Dickinson, M.; Dorritie, K.; Reagan, P. M.; McGuirk, J.; Song, K. W.; Riedell, P. A.; Minnema, M. C.; Yang, Y.; Vardhanabhuti, S.; Filosto, S.; Cheng, P.; Shahani, S. A.; Schupp, M.; To, C.; Locke, F. L.; for the ZUMA-7 Investigators and Kite Members
Article Title: Survival with axicabtagene ciloleucel in large B-cell lymphoma
Abstract: BACKGROUND: In an analysis of the primary outcome of this phase 3 trial, patients with early relapsed or refractory large B-cell lymphoma who received axicabtagene ciloleucel (axi-cel), an autologous anti-CD19 chimeric antigen receptor T-cell therapy, as second-line treatment had significantly longer event-free survival than those who received standard care. Data were needed on longer-term outcomes. METHODS: In this trial, we randomly assigned patients with early relapsed or refractory large B-cell lymphoma in a 1:1 ratio to receive either axi-cel or standard care (two to three cycles of chemoimmunotherapy followed by high-dose chemotherapy with autologous stem-cell transplantation in patients who had a response). The primary outcome was event-free survival, and key secondary outcomes were response and overall survival. Here, we report the results of the prespecified overall survival analysis at 5 years after the first patient underwent randomization. RESULTS: A total of 359 patients underwent randomization to receive axi-cel (180 patients) or standard care (179 patients). At a median follow-up of 47.2 months, death had been reported in 82 patients in the axi-cel group and in 95 patients in the standard-care group. The median overall survival was not reached in the axi-cel group and was 31.1 months in the standard-care group; the estimated 4-year overall survival was 54.6% and 46.0%, respectively (hazard ratio for death, 0.73; 95% confidence interval [CI], 0.54 to 0.98; P = 0.03 by stratified two-sided log-rank test). This increased survival with axi-cel was observed in the intention-to-treat population, which included 74% of patients with primary refractory disease and other high-risk features. The median investigator-assessed progression-free survival was 14.7 months in the axi-cel group and 3.7 months in the standard-care group, with estimated 4-year percentages of 41.8% and 24.4%, respectively (hazard ratio, 0.51; 95% CI, 0.38 to 0.67). No new treatment-related deaths had occurred since the primary analysis of event-free survival. CONCLUSIONS: At a median follow-up of 47.2 months, axi-cel as second-line treatment for patients with early relapsed or refractory large B-cell lymphoma resulted in significantly longer overall survival than standard care. (Funded by Kite; ZUMA-7 ClinicalTrials.gov number, NCT03391466.). Copyright © 2023 Massachusetts Medical Society.
Keywords: controlled study; survival analysis; clinical trial; randomized controlled trial; phase 3 clinical trial; lymphoma, large b-cell, diffuse; adoptive immunotherapy; immunotherapy, adoptive; cd19 antigen; antigens, cd19; biological product; biological products; procedures; diffuse large b cell lymphoma; humans; human; axicabtagene ciloleucel
Journal Title: New England Journal of Medicine
Volume: 389
Issue: 2
ISSN: 0028-4793
Publisher: Massachusetts Medical Society  
Date Published: 2023-07-13
Start Page: 148
End Page: 157
Language: English
DOI: 10.1056/NEJMoa2301665
PUBMED: 37272527
PROVIDER: scopus
DOI/URL:
Notes: Article -- Source: Scopus
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  1. Miguel-Angel Perales
    918 Perales