Am J Hematol. 2020 Aug 3. doi: 10.1002/ajh.25951. Online ahead of print.
Two autologous anti-CD19 chimeric antigen receptors (CAR) T cells (axicabtagene ciloleucel (axi-cel) and tisagenlecleucel (tisa-cel)) are commercially approved in Europe for relapsed/refractory (R/R) diffuse large B cell lymphoma (DLBCL). We performed a retrospective study to evaluate patterns of use, efficacy and safety for axi-cel and tisa-cel. Data from 70 patients who underwent apheresis for commercial CAR T cells between January 2018 and November 2019 in our institution were retrospectively
collected. Sixty-one patients were infused and further analyzed. The median age at infusion was 59 years old (range 27-75 years). The median number of prior therapies was 3 (range, 2 to 6). The overall response rates (ORRs) at 1 month and 3 months were 63% and 45%, respectively, with 48% and 39% achieving a complete response (CR), respectively. After a median follow-up after infusion of 5.7 months, the median progression-free survival (PFS) was 3.0 months (95% CI, 2.8-8.8 months), and the median overall survival (OS) was 11.8 months (95% CI, 6.0-12.6 months). In multivariate analysis, factors associated with poor PFS were the number of previous lines of treatment before CAR T cells (≥4) (P=.010) and a C reactive protein (CRP) value > 30 mg/L at the time of lymphodepletion (P<.001). Likewise, the only factor associated with a shorter OS was CRP > 30 mg/L (P=.009). Cytokine release syndrome (CRS) of any grade occurred in 85% of patients, including 8% of patients with CRS of grade 3 or higher. Immune cell-associated neurotoxicity syndrome (ICANS) of any grade occurred in 28% of patients, including 10% of patients with ICANS of grade 3 or higher. Regarding efficacy and safety, no significant difference was found between axi-cel and tisa-cel. This analysis describes one of the largest real-life cohorts of patients treated with axi-cel and tisa-cel for R/R aggressive B cell lymphoma in Europe. This article is protected by copyright. All rights reserved.