T-cell fitness, metabolic tumor volume, and serum LDH levels are associated with response to axicabtagene ciloleucel.

Axicabtagene ciloleucel (axi-cel) has demonstrated efficacy and safety in relapsed/refractory large B cell lymphoma (r/r LBCL). However, evidence from Asian populations remains limited.This study evaluated patients with r/r LBCL who underwent leukapheresis for axi-cel between April 2023 and December 2025. Fifty-five patients were evaluable for safety, including 38 treated in the second-line setting (2L). CRS occurred in 53 (96%), with grade ≥ 3 in 6 (10%). ICANS occurred in 17 (31%), with grade ≥ 3 in 6 (11%). Compared with patients receiving third-line or later (3L +) treatment, 2L patients experienced higher rates of grade ≥ 3 CRS (13% vs. 6%) and any-grade ICANS (37% vs. 18%). Among the 55 patients, the overall response rate was 91%. After a median follow-up of 14.5 months, the 1.5-year PFS and OS rates were 63.1% and 83.1%, respectively. 2L showed numerically higher PFS than 3L + (1.5-year PFS: 64.9% vs. 57.0%; HR: 1.75; p = 0.248). Multivariate analysis identified three independent risk factors for PFS: low peripheral blood CD8+ naive T-cell count at leukapheresis, high metabolic tumor volume, and elevated LDH level at initiation of lymphodepleting chemotherapy. Axi-cel demonstrated substantial efficacy in Japanese patients with r/r LBCL. The 2L setting was associated with higher toxicity and numerically higher PFS.