Outpatient CAR T-Cell Administration Safe, Feasible for Non-Hodgkin Lymphoma
Earlier and prophylactic interventions have enabled low rates and severity of AEs in recent years of administration.
Radhika Bansal, MBBS
Credit: HealthTree Foundation for Multiple Myeloma
Outpatient administration of axicabtagene ciloleucel (axi-cel) and brexucabtagene autoleucel (brexu-cel) was feasible without high rates of adverse events (AEs) in patients with relapsed/refractory (R/R) B-cell non-Hodgkin lymphoma (B-NHL).
These findings are from an analysis of 155 patients that received brexu-cel or axi-cel at Mayo Clinic in Rochester between January 2018 and December 2022, with follow-up until November 2023. The analysis was presented at the European Hematology Association (EHA) 2024 Hybrid Congress, held June 13-16 in Madrid, Spain, and virtually, by Radhika Bansal, MBBS, postdoctoral fellow, Mayo Clinic.
“Further evidence is needed to understand the safety profile of axi-cel and brexu-cel to optimize management strategies,” Bansal said during her presentation.
Bansal and colleagues analyzed data from 139 patients that received the chimeric antigen receptor (CAR) T-cell therapies in the outpatient setting and 16 that received them in the inpatient setting. Most patients (94%) received axi-cel. Patients were further separated into groups of those who were treated during the late management period (LMP) between 2018 and 2021 and those who were treated during the early management period (EMP) between 2021 and 2022 with earlier/prophylactic steroid strategies. Analyzed participants had similar baseline characteristics.
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The investigators found that between EMP and LMP groups, EMP participants had a lower incidence of cytokine release syndrome (CRS) which resolved earlier, and were prescribed more corticosteroids for CRS and immune effector cell-associated neurotoxicity syndrome (ICANS) than those in the LMP group (all P <.05).Patients in the EMP group also had a shorter median duration of first hospitalization compared with patients in the LMP group (6 vs 10 days; P < .01).
“Even though fewer patients were hospitalized and required fewer ICU visits in the early period, the difference did not reach statistical significance,” Bansal said.
In a predictive analysis, Bansal and colleagues found that elevated lactate dehydrogenase levels at day 0 were associated with increased odds of serious (at least grade 3) within 30 days of infusion (odds ratio [OR], 2.8 [95% CI, 1.0-7.3]). Bridging therapy was also associated with increased odds of hospitalization within 3 days of infusion (OR, 2.9 [95% CI, 1.2-6.7].
Looking specifically at the 116 patients with large B-cell lymphoma(LBCL) that received axi-cel, there was no statistical difference between early rates of CRS or ICANS in the EMP and LMP groups, although the median time to resolution was 4 days in the EMP group compared with 5 days in the LMP group (P <.05). Only patients in the LMP group (23% of LMP group) were admitted to the ICU within 30 days of infusion (P <.01).
Bensal and colleagues also looked at efficacy outcomes between EMP and LMP groups in patients with LBCL, with a median follow-up of 16.5 months (95% CI, 12.6-17.3) and 41.0 months (95% CI, 30.2-51), respectively. Overall response rates were 88% with an 84% complete response (CR) rate in the EMP group and 75% with a 59% CR rate in the LMP group. The EMP group has not reached median duration of response (DOR), progression-free survival (PFS), or overall survival, while the LMP group had a median DOR of 12.9 months, PFS or 4.3 months, and an OS of 22.5 months.
“Results herein provide further evidence that outpatient administration of axi-cel and brexu-cel is feasible without increased AEs for patients with R/R NHL,” Bensal and colleagues wrote. “These results align with previous studies on outpatient CAR T-cell administration, including rates of hospitalization, CRS, and ICANS.”
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