Safety and Efficacy of Axicabtagene Ciloleucel versus Standard of Care in Patients 65 Years of Age or Older with Relapsed/Refractory Large B-Cell Lymphoma

Westin, JR; Locke, FL; Dickinson, M; Ghobadi, A; Elsawy, M; van Meerten, T; Miklos, DB; Ulrickson, ML; Perales, MA; Farooq, U; Wannesson, L; Leslie, L; Kersten, MJ; Jacobson, CA; Pagel, JM; Wulf, G; Johnston, P; Rapoport, AP; Du, L; Vardhanabhuti, S; Filosto, S; Shah, J; Snider, JT; Cheng, P; To, C; Oluwole, OO; Sureda, A

Author(s): Westin, JR; Locke, FL; Dickinson, M; Ghobadi, A; Elsawy, M; van Meerten, T; Miklos, DB; Ulrickson, ML; Perales, MA; Farooq, U; Wannesson, L; Leslie, L; Kersten, MJ; Jacobson, CA; Pagel, JM; Wulf, G; Johnston, P; Rapoport, AP; Du, L; Vardhanabhuti, S; Filosto, S; Shah, J; Snider, JT; Cheng, P; To, C; Oluwole, OO; Sureda, A;
Details: Publication Year 2023-05-15,Volume 29,Issue #10,Page 1894-1905
Journal Title: Clinical Cancer Research
Publication Type: Research article
Abstract: PURPOSE: Older patients with relapsed/refractory (R/R) large B-cell lymphoma (LBCL) may be considered ineligible for curative-intent therapy including high-dose chemotherapy with autologous stem-cell transplantation (HDT-ASCT). Here, we report outcomes of a preplanned subgroup analysis of patients >/=65 years in ZUMA-7. PATIENTS AND METHODS: Patients with LBCL refractory to or relapsed </=12 months after first-line chemoimmunotherapy were randomized 1:1 to axicabtagene ciloleucel [axi-cel; autologous anti-CD19 chimeric antigen receptor (CAR) T-cell therapy] or standard of care (SOC; 2-3 cycles of chemoimmunotherapy followed by HDT-ASCT). The primary endpoint was event-free survival (EFS). Secondary endpoints included safety and patient-reported outcomes (PROs). RESULTS: Fifty-one and 58 patients aged >/=65 years were randomized to axi-cel and SOC, respectively. Median EFS was greater with axi-cel versus SOC (21.5 vs. 2.5 months; median follow-up: 24.3 months; HR, 0.276; descriptive P < 0.0001). Objective response rate was higher with axi-cel versus SOC (88% vs. 52%; OR, 8.81; descriptive P < 0.0001; complete response rate: 75% vs. 33%). Grade >/=3 adverse events occurred in 94% of axi-cel and 82% of SOC patients. No grade 5 cytokine release syndrome or neurologic events occurred. In the quality-of-life analysis, the mean change in PRO scores from baseline at days 100 and 150 favored axi-cel for EORTC QLQ-C30 Global Health, Physical Functioning, and EQ-5D-5L visual analog scale (descriptive P < 0.05). CAR T-cell expansion and baseline serum inflammatory profile were comparable in patients >/=65 and <65 years. CONCLUSIONS: Axi-cel is an effective second-line curative-intent therapy with a manageable safety profile and improved PROs for patients >/=65 years with R/R LBCL.
Publisher: American Association for Cancer Research
Keywords: Humans; Aged; Standard of Care; Immunotherapy, Adoptive/adverse effects; *Lymphoma, Large B-Cell, Diffuse/pathology; *Biological Products/adverse effects; Antigens, CD19
Department(s): Clinical Haematology
PubMed ID: 36999993
Publisher's Version: https://doi.org/10.1158/1078-0432.CCR-22-3136
Terms of Use/Rights Notice: Refer to copyright notice on published article.

Creation Date: 2023-09-05 06:33:36

Last Modified: 2024-07-30 02:09:58