Long-term outcomes of patients with large B-cell lymphoma treated with axicabtagene ciloleucel and prophylactic corticosteroids.

Abstract

ZUMA-1 safety management cohort 6 investigated the impact of prophylactic corticosteroids and earlier corticosteroids and/or tocilizumab on the incidence and severity of cytokine release syndrome (CRS) and neurologic events (NEs) following axicabtagene ciloleucel (axi-cel) in patients with relapsed/refractory large B-cell lymphoma (R/R LBCL). Prior analyses of cohort 6 with limited follow-up demonstrated no Grade ≥3 CRS, a low rate of NEs, and high response rates, without negatively impacting axi-cel pharmacokinetics. Herein, long-term outcomes of cohort 6 (N = 40) are reported (median follow-up, 26.9 months). Since the 1-year analysis (Oluwole, et al. Blood. 2022;138[suppl 1]:2832), no new CRS was reported. Two new NEs occurred in two patients (Grade 2 dementia unrelated to axi-cel; Grade 5 axi-cel-related leukoencephalopathy). Six new infections and eight deaths (five progressive disease; one leukoencephalopathy; two COVID-19) occurred. Objective and complete response rates remained at 95% and 80%, respectively. Median duration of response and progression-free survival were reached at 25.9 and 26.8 months, respectively. Median overall survival has not yet been reached. Eighteen patients (45%) remained in ongoing response at data cutoff. With ≥2 years of follow-up, prophylactic corticosteroids and earlier corticosteroids and/or tocilizumab continued to demonstrate CRS improvement without compromising efficacy outcomes, which remained high and durable.

• Authors: Olalekan O Oluwole, Edouard Forcade, Javier Muñoz, Sophie de Guibert, Julie M Vose, Nancy L Bartlett, Yi Lin, Abhinav Deol, Peter McSweeney, Andre H Goy, Marie José Kersten, Caron A Jacobson, Umar Farooq, Monique C Minnema, Catherine Thieblemont, John M Timmerman, Patrick Stiff, Irit Avivi, Dimitrios Tzachanis, Yan Zheng, Saran Vardhanabhuti, Jenny Nater, Rhine R Shen, Harry Miao, Jenny J Kim, Tom van Meerten
• Journal: Bone marrow transplantation (Bone Marrow Transplant) Vol. 59 Issue 3 Pg. 366-372 (Mar 2024) ISSN: 1476-5365 [Electronic] England
• PMID: 38177222 (Publication Type: Journal Article)
• Copyright: © 2024. The Author(s).

Chemical References

• axicabtagene ciloleucel
• Adrenal Cortex Hormones
• Biological Products
• Antigens, CD19

Topics

• Humans
• Lymphoma, Large B-Cell, Diffuse
• Adrenal Cortex Hormones (therapeutic use)
• Biological Products (therapeutic use)
• Cytokine Release Syndrome
• Leukoencephalopathies
• Immunotherapy, Adoptive
• Antigens, CD19