帕博利珠单抗作为维持和/或桥接治疗的 CAR-T 细胞疗法在复发/难治性原发纵隔大 B 细胞淋巴瘤中的真实世界结局

Clinical data on chimeric antigen receptor (CAR) T-cell therapy in Japanese patients with relapsed/refractory primary mediastinal large B-cell lymphoma (R/R PMBCL) are limited. This study evaluated the safety and long-term outcomes of CAR T-cell therapy in R/R PMBCL, including the impact of pembrolizumab used as holding (pre-apheresis) and/or bridging (post-apheresis) therapy.

We retrospectively analyzed patients with R/R PMBCL receiving axicabtagene ciloleucel or lisocabtagene maraleucel at our institution between October 2021 and October 2025. Treatment efficacy and survival outcomes were compared with those of patients with other large B-cell lymphoma (LBCL) treated with CAR T-cell therapy. Pembrolizumab administration as holding and/or bridging therapy was also assessed.

Twelve patients with PMBCL received CAR T-cell therapy, with a median follow-up of 24 months. The overall and complete response rates were both 92%. The 2-year progression-free survival (PFS) and overall survival rates were also 92%. Cytokine release syndrome was limited to grade 2, and immune effector cell-associated neurotoxicity syndrome occurred in one patient. Ten patients received pembrolizumab, which was associated with reduced metabolic tumor volume from leukapheresis to CAR T-cell infusion and manageable immune-related adverse events. Compared with other LBCL, PMBCL demonstrated favorable outcomes, with a 1-year PFS of 92% versus 65% in other LBCL (hazard ratio, 5.25; 95% confidence interval, 0.720-38.21; p = 0.067).

CAR T-cell therapy demonstrated durable responses and a manageable safety profile in R/R PMBCL, including in patients receiving pembrolizumab as holding and/or bridging therapy, supporting its use as a promising treatment option.