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<p>Treatment options for relapsed or refractory extranodal natural killer/T-cell lymphoma (R/R ENKTL) remain limited. In this phase 1b/2 trial (NCT05464433), we evaluated the safety and efficacy of liposomal mitoxantrone (Lipo-MIT) plus anti-PD-1 tislelizumab in this setting. During dose escalation, patients received Lipo-MIT (16 or 20 mg/m<sup>2</sup>) plus tislelizumab using a 3 + 3 design, followed by dose expansion at the recommended phase 2 dose (RP2D). The primary endpoint of the dose-escalation phase was dose-limiting toxicities (DLTs), which were assessed to determine the RP2D. The primary efficacy endpoint of the dose-expansion phase was the best complete response (CR) rate. Between July 23 2022 and November 28 2024, 40 patients received study treatment (dose-escalation, <i>n</i> = 6; dose-expansion, <i>n</i> = 34). No DLTs were observed and the RP2D of Lipo-MIT was 20 mg/m<sup>2</sup>. The prespecified primary efficacy endpoint was met, with a CR rate of 53% (21/40; one-sided 95% lower confidence bound, 38%). The median progression-free survival (secondary endpoint) was 8.2 months (95% confidence interval, 6.1-not estimable) after a median follow-up of 15.3 months. The most common grade ≥ 3 adverse events were leukopenia (53%), neutropenia (40%), and febrile neutropenia (18%). In conclusion, Lipo-MIT plus tislelizumab showed promising anti-tumor activity with an acceptable safety profile in R/R ENKTL.</p>

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Liposomal mitoxantrone plus tislelizumab in patients with relapsed or refractory extranodal natural killer/T-cell lymphoma: a phase 1b/2 trial

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年6月15日

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  • Qihua Zou,
  • Shenrui Bai,
  • Liang Wang,
  • Hongyan Tong,
  • Dongfeng Zeng,
  • Ying Zhao,
  • Yuerong Shuang,
  • Xiaobo Wang,
  • Xiuhua Sun,
  • Zhenya Hong,
  • Zhigang Peng,
  • Yu Yang,
  • Runhui Zheng,
  • Huiqiang Huang,
  • Jianbo Liu,
  • Chunmei Yang,
  • Xi Li,
  • Xin Gao,
  • Hao Xu,
  • Daoguang Chen,
  • Xiaojie Fang,
  • Man Nie,
  • Jinni Wang,
  • Xinna Gao,
  • Jingjing Ye,
  • Wei Zhang,
  • Jianzhen Shen,
  • Rong Tao,
  • Hong Cen,
  • Yuchen Zhang,
  • Jun Cai,
  • Yi Xia,
  • Qingqing Cai

摘要

Treatment options for relapsed or refractory extranodal natural killer/T-cell lymphoma (R/R ENKTL) remain limited. In this phase 1b/2 trial (NCT05464433), we evaluated the safety and efficacy of liposomal mitoxantrone (Lipo-MIT) plus anti-PD-1 tislelizumab in this setting. During dose escalation, patients received Lipo-MIT (16 or 20 mg/m2) plus tislelizumab using a 3 + 3 design, followed by dose expansion at the recommended phase 2 dose (RP2D). The primary endpoint of the dose-escalation phase was dose-limiting toxicities (DLTs), which were assessed to determine the RP2D. The primary efficacy endpoint of the dose-expansion phase was the best complete response (CR) rate. Between July 23 2022 and November 28 2024, 40 patients received study treatment (dose-escalation, n = 6; dose-expansion, n = 34). No DLTs were observed and the RP2D of Lipo-MIT was 20 mg/m2. The prespecified primary efficacy endpoint was met, with a CR rate of 53% (21/40; one-sided 95% lower confidence bound, 38%). The median progression-free survival (secondary endpoint) was 8.2 months (95% confidence interval, 6.1-not estimable) after a median follow-up of 15.3 months. The most common grade ≥ 3 adverse events were leukopenia (53%), neutropenia (40%), and febrile neutropenia (18%). In conclusion, Lipo-MIT plus tislelizumab showed promising anti-tumor activity with an acceptable safety profile in R/R ENKTL.