Survival with Axicabtagene Ciloleucel in Large B-Cell Lymphoma

Westin, JR; Oluwole, OO; Kersten, MJ; Miklos, DB; Perales, MA; Ghobadi, A; Rapoport, AP; Sureda, A; Jacobson, CA; Farooq, U; van Meerten, T; Ulrickson, M; Elsawy, M; Leslie, LA; Chaganti, S; Dickinson, M; Dorritie, K; Reagan, PM; McGuirk, J; Song, KW; Riedell, PA; Minnema, MC; Yang, Y; Vardhanabhuti, S; Filosto, S; Cheng, P; Shahani, SA; Schupp, M; To, C; Locke, FL; ZUMA-7 Investigators; Kite Members

Author(s): Westin, JR; Oluwole, OO; Kersten, MJ; Miklos, DB; Perales, MA; Ghobadi, A; Rapoport, AP; Sureda, A; Jacobson, CA; Farooq, U; van Meerten, T; Ulrickson, M; Elsawy, M; Leslie, LA; Chaganti, S; Dickinson, M; Dorritie, K; Reagan, PM; McGuirk, J; Song, KW; Riedell, PA; Minnema, MC; Yang, Y; Vardhanabhuti, S; Filosto, S; Cheng, P; Shahani, SA; Schupp, M; To, C; Locke, FL; ZUMA-7 Investigators; Kite Members;
Details: Publication Year 2023-07-13,Volume 389,Issue #2,Page 148-157
Journal Title: New England Journal of Medicine
Publication Type: Research article
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.).
Publisher: Massachusetts Medical Society
Keywords: Humans; Antigens, CD19/therapeutic use; *Antineoplastic Agents, Immunological/therapeutic use; *Biological Products/therapeutic use; Immunotherapy, Adoptive/adverse effects/methods; *Lymphoma, Large B-Cell, Diffuse/drug therapy; Survival Analysis
Department(s): Clinical Haematology
PubMed ID: 37272527
Publisher's Version: https://doi.org/10.1056/NEJMoa2301665
Open Access at Publisher's Site: https://doi.org/10.1056/NEJMoa2301665
Terms of Use/Rights Notice: Refer to copyright notice on published article.

Creation Date: 2023-10-16 11:42:27

Last Modified: 2023-10-16 11:42:48