Journal Article

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

Kersten, Marie José, Farooq, Umar, Kim, Jenny J, Jacobson, Caron A, Bartlett, Nancy L, Muñoz, Javier, de Guibert, Sophie, Vardhanabhuti, Saran, Nater, Jenny, Stiff, Patrick, Zheng, Yan, Shen, Rhine R, cade, Edouard, Deol, Abhinav, Goy, Andre H, Timmerman, John M, Miao, Harry, Vose, Julie M, McSweeney, Peter, Minnema, Monique C, Thieblemont, Catherine, Tzachanis, Dimitrios, van Meerten, Tom, Oluwole, Olalekan O, Lin, Yi, Avivi, Irit

2024

Overview

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.

• Publisher: Nature Publishing Group
• Subject: B-cell lymphoma / Corticoids / Corticosteroids / COVID-19 / Dementia disorders / Leukoencephalopathy / Lymphocytes B / Lymphoma / Monoclonal antibodies / Pharmacokinetics / Response rates / Safety management / Steroids / Survival