Hutchison China MediTech presents results from Phase III stufe of surufatinib
Hutchison China MediTech presented the results of the Phase III study of surufatinib in advanced neuroendocrine tumors - extra-pancreatic at the 2019 European Society for Medical Oncology Congress. The study has met the pre-defined primary endpoint of progression free survival early. Patients treated with surufatinib were 67% less likely to see their disease progress or die as compared to patients on placebo control, assessed by local investigators. As announced in June 2019, the independent Data Monitoring Committee for the trial recommended that the study stop early because it had met the pre-defined primary endpoint of PFS during a planned interim analysis. Preparations are now underway for the potential NDA submission by year end 2019 for this indication in China. At data cut-off as of March 31, 2019, 198 patients were randomized 2:1 to treatment with either 300 mg of surufatinib orally daily or placebo control on a 28-day cycle. Median PFS per investigator assessment was 9.2 months for patients treated with surufatinib, as compared to 3.8 months for patients in the placebo group. The efficacy of surufatinib was seen across all subgroups, and supported by statistically significant improvement as measured by secondary efficacy endpoints including objective response rate, disease control rate, time to response, duration of response, safety, and tolerability. Efficacy was also supported by Blinded Independent Image Review Committee assessment. Overall survival data was not mature, with only 18.7% OS events at data cut-off. Surufatinib was generally well-tolerated in this study and the safety profile is consistent with observations in prior clinical studies.