Surufatinib holds promise in treatment of NETs in phase I/IIb trial
Surufatinib has demonstrated encouraging antitumour activity with manageable toxicity profile in patients with extrapancreatic neuroendocrine tumours (NETs), according to the results of a phase I/IIb trial.
The trial included 81 patients (median age, 49 years; 54 percent men), among whom 42 had pancreatic NETs and 39 had extrapancreatic NETs. Most patients had radiologic progression within 1 year of enrolment (79 percent). On the other hand, 21 percent of patients showed clinical deterioration.
All patients received surufatinib 300 mg orally, once daily. Most patients had radiologic progression within 1 year prior to enrolment (32 patients in each cohort). Primary endpoints investigated were objective response rate (ORR) and safety.
ORRs were 19 percent (95 percent CI, 9–340) in the pancreatic NET cohort and 15 percent (6–31) in the extrapancreatic NET cohort. Disease control rates were 91 percent (77–97) and 92 percent (79-98), while median progression-free survival was 21.2 months (15.9–24.8) and 13.4 months (7.6–19.3), respectively.
In terms of safety, frequently reported grade ≥3 treatment-related adverse events were hypertension (33 percent), proteinuria (12 percent), hyperuricaemia (10 percent), hypertriglyceridaemia and diarrhoea (6 percent for each), and increased alanine aminotransferase (5 percent).
The treatment benefit observed in the current trial will be confirmed in two phase III trials, researchers said.
Surufatinib is a small-molecule inhibitor targeting vascular endothelial growth factor receptors, fibroblast growth factor receptor 1 and colony-stimulating factor 1 receptor. To date, no antiangiogenic treatment is yet approved for NETs.