Axi-cel delivers similar outcomes regardless of ASCT-eligibility in second line R/R LBCL: Combined data from ZUMA-7 and ALYCANTE

作者：Roch Houot, Pablo Arija, Emmanuel Bachy, Guillaume Cartron, François‐Xavier Gros, Franck Morschhauser, Cédric Portugues, Catherine Thieblemont, Markqayne Ray, Yin Yang, Sante Cundari, Camille Linot, Divyesh Mistry, Martijn Simons, Anna Gittfried, François A. Lemonnier · 发表于：Blood · 年份：2025 · DOI：10.1182/blood-2025-3714 · 被引用次数：2 · 研究领域：CAR-T cell therapy research、Lymphoma Diagnosis and Treatment、Cutaneous lymphoproliferative disorders research

Abstract Introduction ZUMA-7 (NCT03391466) and ALYCANTE (NCT04531046) evaluated axicabtagene ciloleucel (axi-cel), a chimeric antigen receptor T-cell (CART) therapy, as second-line (2L) therapy in patients with high-risk relapsed/refractory large B-cell lymphoma (R/R LBCL), with ZUMA-7 patients being autologous stem-cell transplant (ASCT) eligible whereas ALYCANTE patients were ASCT ineligible. With CAR T now established as 2L standard of care, this analysis assessed efficacy, safety and HRQoL across the full CAR T–eligible population to explore whether ASCT eligibility impacts axi-cel outcomes. Methods Data from axi-cel patients in ZUMA-7 and ALYCANTE were pooled without weighting. Efficacy endpoints evaluated in this analysis were event-free survival (EFS), overall response rate (complete + partial metabolic response [CMR + PMR]) and CMR, defined from leukapheresis; overall survival (OS) and progression-free survival (PFS), defined from axi-cel infusion; and duration of response (DOR). EFS and other time-to-event (TTE) outcomes were analyzed using Kaplan-Meier methods with aligned and pre-specified definitions and censoring rules. CMR and ORR were summarized with response rates. Safety was evaluated based on treatment-emergent adverse events (TEAEs) occurring after axi-cel infusion. Both trials included patient-reported outcomes using EQ-5D-5L and EORTC QLQ-C30. Longitudinal HRQoL outcomes were assessed using mixed models for repeated measures. Results ZUMA-7 had a 4-year f...