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Surufatinib plus toripalimab for patients with advanced solid tumors and disease progression after prior

Panpan Zhang1, Ming Lu2, Lijie Song3

  • 1Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Early Drug Development Centre, Peking University Cancer Hospital & Institute, No. 52 Fucheng Road, Haidian District, Beijing, China.

Cancer Immunology, Immunotherapy : CII
|June 13, 2026
PubMed
Abstract

Insights

This phase 2 trial showed that combining surufatinib with toripalimab (a programmed-death-1 inhibitor) demonstrated antitumor activity in advanced solid tumors that had progressed on prior immunotherapy, with a manageable safety profile.

Area of Science:

  • Oncology
  • Immunotherapy
  • Pharmacology

Background:

  • Combination immunotherapy with anti-angiogenic agents shows promise in treating advanced solid tumors after prior immune checkpoint inhibitor (ICI) therapy.
  • Further research is needed to evaluate this combination across diverse tumor types.

Purpose of the Study:

  • To assess the efficacy and safety of surufatinib plus toripalimab in patients with advanced solid tumors who progressed on a programmed-death-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor.

Main Methods:

  • A phase 2 trial enrolled adult patients with advanced solid tumors and prior progression on PD-1/PD-L1 inhibitors.
  • Patients received surufatinib (anti-angiogenic multi-tyrosine-kinase inhibitor) orally once daily and toripalimab (PD-1 inhibitor) intravenously every three weeks.
  • The primary endpoint was investigator-assessed objective response rate (ORR) using RECIST v1.1 criteria.

Main Results:

  • The objective response rate (ORR) was 7.4% (2 partial responses in 27 evaluable patients), with a disease control rate of 66.7%.
  • Median progression-free survival was 3.9 months, and median overall survival was 13.0 months.
  • Grade ≥3 treatment-related adverse events occurred in 39.3% of patients, most commonly increased blood pressure and liver damage; no treatment-related deaths were reported.

Conclusions:

  • The combination of surufatinib and toripalimab demonstrated signal-generating activity in patients with advanced solid tumors following progression on prior ICI therapy.
  • The combination exhibited a manageable safety profile, suggesting potential for future studies in larger patient populations.
Keywords:
Combination drug therapyImmune checkpoint inhibitor rechallengeMalignant neoplasmSurufatinibToripalimab

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