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Anlotinib plus toripalimab in patients with advanced bone and soft tissue sarcomas including ultra-rare sarcomas: A

Qiuzhong Pan1, Bushu Xu1, Lihong Zhang2

  • 1Melanoma and sarcoma Medical Oncology Unit, Sun Yat-sen University Cancer Center, China; State Key Laboratory of Oncology in South China, Collaborative innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.

European Journal of Cancer (Oxford, England : 1990)
|June 8, 2026
PubMed
Abstract

Insights

Anlotinib plus toripalimab showed promising activity in advanced sarcomas, including ultra-rare types. Lower baseline monocyte counts predicted better outcomes, suggesting a potential biomarker for treatment response.

Area of Science:

  • Oncology
  • Clinical Pharmacology
  • Biomarker Research

Background:

  • Advanced sarcomas, especially ultra-rare sarcomas (URS), have limited treatment options.
  • This study investigated the combination therapy of anlotinib and toripalimab for advanced sarcomas.

Purpose of the Study:

  • To evaluate the anti-tumor activity and safety of anlotinib combined with toripalimab in a diverse sarcoma patient population.
  • To identify potential biomarkers for treatment response in advanced sarcomas.

Main Methods:

  • A single-arm, phase 2 clinical trial involving 70 patients with advanced sarcomas.
  • Patients received anlotinib (12 mg days 1-14) plus toripalimab (240 mg day 1) every 3 weeks.
  • Primary endpoint was objective response rate (ORR); secondary endpoints included progression-free survival (PFS), overall survival (OS), and safety.

Main Results:

  • The confirmed ORR was 29% (95% CI: 19-42%) with a disease control rate (DCR) of 90%.
  • Median PFS was 7.0 months and median OS was 27.0 months. In soft-tissue URS patients, ORR was 39% and median PFS was 11.0 months.
  • Common grade ≥3 adverse events included hypertension and hand-foot syndrome. Lower baseline monocyte counts were associated with improved PFS and OS.

Conclusions:

  • Anlotinib plus toripalimab demonstrates promising anti-tumor activity and manageable toxicity in heavily pretreated advanced sarcomas, including URS.
  • This combination therapy holds potential for treating advanced sarcomas.
  • Baseline monocyte count may serve as a pragmatic, non-invasive biomarker for predicting treatment outcomes, warranting further validation.
Keywords:
Advanced sarcomasAnlotinibToripalimabUltra-rare sarcomas

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