Outpatient axicabtagene ciloleucel for relapsed/refractory large B-cell lymphoma: ZUMA-24 primary analysis.

Abstract

ZUMA-24 is a Phase 2, open-label, multicenter study that investigated safety and efficacy of axicabtagene ciloleucel (axi-cel), an autologous anti-CD19 chimeric antigen receptor (CAR) T-cell therapy, administered in the outpatient setting to patients with relapsed or refractory large B-cell lymphoma (R/R LBCL) with ≥1 prior lines of therapy. Patients underwent leukapheresis and received lymphodepleting chemotherapy, axi-cel infusion (2×10⁶ CAR T cells/kg), and prophylactic steroids. Patients were monitored daily ≥7 days after infusion per institutional outpatient monitoring guidelines. The primary endpoint was incidence and severity of cytokine release syndrome (CRS) and neurologic events (NEs). Median follow-up was 13 months for 30 patients treated with outpatient axi-cel. Grade 1-2 CRS was reported in 90% of patients, with no grade ≥3 CRS. NEs of any grade were reported in 80% of patients (grade ≥3, 23%; no patients died due to NEs). Median time to onset was 4 days for CRS and 7 days for NEs, with a median duration of 5 days and 6 days, respectively. All patients experienced AEs of any grade (grade ≥3, 83%). After axi-cel, 93% of patients were hospitalized, with 4 days median time to first hospitalization (8 days median stay), and 4 patients (13%) were admitted to the ICU (for 2-7 days). Among patients evaluable for efficacy (n=29), the objective response rate was 93% (complete response, 76%), with a median duration of response of 11.4 months. These results support safety and feasibility of outpatient administration of axi-cel. This trial is registered at ClinicalTrials.gov: #NCT05459571.