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.
Clinical cancer research : an official journal of the American Association for Cancer Research
washington; swedish; swedish cancer; Humans; Aged; Standard of Care; Immunotherapy, Adoptive; Lymphoma, Large B-Cell, Diffuse; Biological Products; Antigens, CD19
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
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.
Westin, Jason R; Locke, Frederick L; Dickinson, Michael; Ghobadi, Armin; Elsawy, Mahmoud; van Meerten, Tom; Miklos, David B; Ulrickson, Matthew L; Perales, Miguel-Angel; Farooq, Umar; Wannesson, Luciano; Leslie, Lori; Kersten, Marie José; Jacobson, Caron A; Pagel, John M; Wulf, Gerald; Johnston, Patrick; Rapoport, Aaron P; Du, Linqiu; Vardhanabhuti, Saran; Filosto, Simone; Shah, Jina; Snider, Julia T; Cheng, Paul; To, Christina; Oluwole, Olalekan O; and Sureda, Anna, "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." (2023). Articles, Abstracts, and Reports. 7261.