Liposomal mitoxantrone plus tislelizumab in patients with relapsed or refractory extranodal natural killer/T-cell

Qihua Zou1,2, Shenrui Bai1,3, Liang Wang4

  • 1State Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University Cancer Center, Guangzhou, P.R. China.

Nature Communications
|June 15, 2026
PubMed

Insights

This study shows liposomal mitoxantrone plus tislelizumab is a safe and effective treatment for relapsed or refractory extranodal natural killer/T-cell lymphoma (R/R ENKTL). The combination therapy achieved a 53% complete response rate, offering new hope for patients with limited options.

Area of Science:

  • Hematology
  • Oncology
  • Clinical Trials

Background:

  • Relapsed or refractory extranodal natural killer/T-cell lymphoma (R/R ENKTL) has limited treatment options.
  • There is an unmet need for novel therapeutic strategies in R/R ENKTL.

Purpose of the Study:

  • To evaluate the safety and efficacy of liposomal mitoxantrone (Lipo-MIT) combined with the anti-PD-1 antibody tislelizumab in patients with R/R ENKTL.
  • To determine the recommended phase 2 dose (RP2D) of Lipo-MIT in this patient population.

Main Methods:

  • A phase 1b/2 clinical trial (NCT05464433) involving dose escalation and dose expansion phases.
  • Patients received escalating doses of Lipo-MIT (16 or 20 mg/m²) plus tislelizumab, with dose-limiting toxicities (DLTs) assessed during dose escalation to determine the RP2D.
  • The primary efficacy endpoint was the best complete response (CR) rate in the dose expansion phase.

Main Results:

  • No DLTs were observed, and the RP2D of Lipo-MIT was established at 20 mg/m².
  • A CR rate of 53% (21/40) was achieved, meeting the primary efficacy endpoint.
  • Median progression-free survival was 8.2 months. Common grade ≥3 adverse events included leukopenia (53%), neutropenia (40%), and febrile neutropenia (18%).

Conclusions:

  • Liposomal mitoxantrone plus tislelizumab demonstrates promising anti-tumor activity in R/R ENKTL.
  • The combination therapy exhibits an acceptable safety profile in this patient group.
  • This regimen represents a potential new treatment option for patients with R/R ENKTL.