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Background <p>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.</p> Methods <p>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.</p> Results <p>Twelve patients with PMBCL received CAR T-cell therapy, with a median follow-up of 24&#xa0;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; <i>p</i> = 0.067).</p> Conclusions <p>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.</p>

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Real-world outcomes of chimeric antigen receptor T-cell therapy with pembrolizumab as holding and/or bridging therapy in relapsed/refractory primary mediastinal large B-cell lymphoma

  • 期刊论文

  • 发表日期：

    2026年4月13日

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  • Risa Nishiyama,
  • Shinichi Makita,
  • Anna Hiratsuka,
  • Akiko Miyagi Maeshima,
  • Kimiteru Ito,
  • Yu Aruga,
  • Chiaki Ikeda,
  • Hirotaka Matsui,
  • Wataru Takeda,
  • Mai Takeuchi,
  • Tetsuro Ochi,
  • Noriko Iwaki,
  • Suguru Fukuhara,
  • Wataru Munakata,
  • Koji Izutsu

摘要

Background

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.

Methods

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.

Results

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).

Conclusions

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.