Surufatinib in advanced neuroendocrine tumors - extra-pancreatic,met the primary endpoint of progression free survival

Hutchison China MediTech announced that the independent Data Monitoring Committee of the Phase III pivotal study of surufatinib in advanced neuroendocrine tumors – extra-pancreatic, has completed a planned interim analysis. The IDMC determined that the study has already met the pre-defined primary endpoint of progression free survival and as a result the study will be stopped.

Chi-Med will now arrange for a pre-New Drug Application meeting with the China National Medical Products Administration to discuss the preparation of the NDA for surufatinib for this indication.

SANET-ep is a Phase III study in China of surufatinib in patients with low- or intermediate-grade advanced extra-pancreatic neuroendocrine tumors patients for whom there is no effective therapy. In this study, patients are randomized at a 2:1 ratio to receive either 300 mg of surufatinib orally daily or placebo, on a 28-day treatment cycle. The primary endpoint of the study is to evaluate the PFS, with secondary endpoints including objective response rate (ORR), disease control rate (DCR), time to response (TTR), duration of response (DoR), overall survival (OS), safety, and tolerability.