Sintilimab Plus Anlotinib Shows Promising Antitumor Activity in Advanced Sarcomas

Strategic Insights -

Advanced sarcomas, a rare and aggressive type of cancer, have limited treatment options. Researchers from Shandong Cancer Hospital in China investigated the efficacy and safety of combining sintilimab and anlotinib, two immunotherapies, in treating advanced sarcomas. The study involved 42 patients with untreated or chemotherapy-resistant sarcomas. The combination treatment resulted in a 30.9% objective response rate (ORR) and 76.2% disease control rate (DCR). The median progression-free survival (PFS) was 5.0 months, and the median overall survival (OS) was not reached.

Key Takeaways:

  • Advanced sarcomas have limited treatment options, and this study aimed to investigate the efficacy and safety of combining sintilimab and anlotinib in treating this condition.
  • A total of 42 patients with untreated or chemotherapy-resistant sarcomas were enrolled in the study, and 40 (95.2%) patients were non-alveolar soft part sarcoma (ASPS).
  • The combination treatment resulted in a 30.9% objective response rate (ORR) and 76.2% disease control rate (DCR).
  • The most common adverse events (AEs) included elevated lactate dehydrogenase (28.57%), hypoproteinemia (21.43%), and increased thyroid stimulating hormone (21.43%).
  • The most common grade 3 AEs were hypertension (4.76%) and hyponatremia (4.76%).
  • Two serious AEs (one hepatitis and one intestinal perforation) were recorded.
  • The study found that the ORR in TLS-positive patients (n = 7) was significantly higher than that in TLS-negative patients (n = 28) at 71.4% vs. 25.0% (p = 0.033).
  • The study concluded that sintilimab plus anlotinib demonstrated promising antitumor activity with manageable toxicity in advanced sarcomas, particularly among TLS-positive patients.

Statistics:

  • 42 patients were enrolled in the study.
  • 40 (95.2%) patients were non-ASPS.
  • 30.9% objective response rate (ORR).
  • 76.2% disease control rate (DCR).
  • 95% CI for ORR: 16.4-45.5%
  • 95% CI for DCR: 62.8-89.6%
  • Median progression-free survival (PFS): 5.0 months (95% CI: 2.8-10.2).
  • Median overall survival (OS): not reached.
  • Elevated lactate dehydrogenase (28.57%).
  • Hypoproteinemia (21.43%).
  • Increased thyroid stimulating hormone (21.43%).
  • Hypertension (4.76%).
  • Hyponatremia (4.76%).
  • 2 serious AEs (1 hepatitis and 1 intestinal perforation).

Sources:

  • Sintilimab plus anlotinib in patients with pre-treated locally advanced or metastatic sarcoma: a prospective, single-arm, phase II clinical trial. Cancer Immunology Research, 2025.
  • Amer Assoc Cancer Research, 615 Chestnut St, 17TH Floor, Philadelphia, PA 19106-4404, USA.
  • Zengjun Liu, Shandong Cancer Hospital and Institute. Shandong First Medical University and Shandong Academy of Medical Sciences., Jinan, Shandong, People's Republic of China.
  • Heng Fu, Mengyao Liu, Jing Xu, Xin Xu, Ting Hao, Guiying Wei, Hongtu Yuan, Jianbo Zhang, and Dongyuan Zhu.