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

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 ZhengSaran Vardhanabhuti, Jenny Nater, Rhine R. Shen, Harry Miao, Jenny J. Kim, Tom van Meerten

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish
Pages (from-to)366-372
Number of pages7
JournalBone Marrow Transplantation
Volume59
Issue number3
DOIs
StatePublished - Mar 2024

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