Trial reportCancer immunology, immunotherapy : CII2026
Surufatinib plus toripalimab for patients with advanced solid tumors and disease progression after prior immunotherapy: an open-label multi-cohort phase 2 trial.
Trial report in Cancer immunology, immunotherapy : CII, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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15 authors.
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Abstract
backgroundImmune checkpoint inhibitor (ICI) plus an anti-angiogenic agent has shown antitumor activity in patients whose disease had progressed on a prior ICI but further evidence across tumor types is needed.
methodsThis phase 2 trial evaluated the efficacy and safety of surufatinib (anti-angiogenic multi-tyrosine-kinase inhibitor, 250 mg orally, once daily) plus toripalimab (programmed-death-1 [PD-1] inhibitor, 240 mg intravenously, once every three weeks) in adult patients with advanced solid tumors and progression on a PD-1/programmed death ligand 1 inhibitor. The primary endpoint was investigator-assessed objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
resultsA total of 28 patients were enrolled and received treatment. Two of 27 evaluable patients achieved partial response, for an ORR of 7.4% (95% CI: 0.9-24.3); the disease control rate was 66.7% (95% CI: 46.0-83.5). Median progression-free survival was 3.9 months (95% CI: 1.4-4.2) and overall survival was 13.0 months (95% CI: 8.6-21.6; median follow-up: 20.9 months). Efficacy findings were consistent when assessed per immune-related RECIST. Eleven (39.3%) patients experienced grade ≥ 3 treatment-related adverse events (TRAEs), most frequently increased blood pressure (n = 3, 10.7%) and liver damage (n = 2, 7.1%). TRAEs led to surufatinib discontinuation in two (7.1%) patients. There were no treatment-related deaths.
conclusionsICI-based combination rechallenge with surufatinib-toripalimab conferred signal-generating activity in patients with advanced solid tumors, with a manageable safety profile. Studies in larger populations are warranted.
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