Is Outpatient Administration of Brexucabtagene Autoleucel Safe for Patients With Acute Lymphoblastic Leukemia and Mantle Cell Lymphoma?

A retrospective analysis of brexucabtagene autoleucel (brexu-cel) administration in patients with relapsed/refractory acute lymphoblastic leukemia (ALL) and mantle cell lymphoma (MCL) suggests that outpatient (OP) administration is both safe and feasible. Compared to inpatient (IP) administration, the study found no increase in day-60 non-relapse mortality (NRM), cytokine release syndrome (CRS), or neurotoxicity, while demonstrating reduced hospitalization times and similar efficacy. This paper was presented at the 66th American Society of Hematology Annual Meeting & Exposition in San Diego, CA.

Brexu-cel has demonstrated efficacy for relapsed/refractory B-cell malignancies, with established use from trials like ZUMA-2 and ZUMA-3. However, its higher toxicity rates compared with other chimeric antigen receptor (CAR) T-cell therapies have led to limited data on its OP use. This study aimed to evaluate whether OP administration could achieve comparable outcomes to IP administration.

The researchers retrospectively reviewed 69 adult patients who received brexu-cel between November 2020 to March 2024. Patients were divided into two cohorts: those initiating lymphodepletion as outpatients (LDOP) and those as inpatients (LDIP). Propensity score matching based on performance status, comorbidities, and disease burden was used to balance groups, resulting in 56 matched patients (28 per group). Outcomes assessed included 60-day NRM, CRS, immune effector cell-associated neurotoxicity syndrome (ICANS), complete response rates (CRR), progression-free survival (PFS), and hospitalization metrics.

Among matched patients, 60-day NRM was 7.1% in the LDIP group versus 3.6% in the LDOP group. Toxicity profiles were comparable: any-grade CRS occurred in 82% of LDIP patients versus 86% in LDOP, while greater than or equal to grade 3 CRS was observed in 14% and 7.1%, respectively. ICANS incidence and severity were similarly balanced, with greater than or equal to grade 3 ICANS reported in 25% of LDIP and 29% of LDOP patients. Median hospitalization duration within 100 days of treatment was significantly shorter for LDOP patients (10 days vs. 27 days; P < .001). PFS rates at 6 months were 74% in the LDIP group versus 87% in LDOP. Complete response rates for MCL were 73% in LDIP versus 75% in LDOP, and for B-ALL, 88% versus 90%, respectively.

“Brexu-cel is safe to administer OP with similar efficacy and NRM,” the study authors concluded. “Future studies with larger sample size and longer follow-up are needed to confirm our findings.”

Reference

Othman T, Baird JH, Wang Y, et al. Outpatient administration of brexucabtagene autoleucel for acute lymphoblastic leukemia and mantle cell lymphoma is safe and feasible. Paper presented at: American Society of Hematology Annual Meeting; December 7-10, 2024; San Diego, CA. Accessed December 2, 2024. https://ash.confex.com/ash/2024/webprogram/Paper207085.html .