Chi-Med’s Surufatinib Study Meets Primary Endpoint Early
Stops Phase III study of surufatinib in advanced neuroendocrine tumors, meeting the primary endpoint of progression free survival
Hutchison China MediTech Ltd. announced that the independent Data Monitoring Committee (IDMC) of the Phase III study of surufatinib in advanced neuroendocrine tumors – extra-pancreatic (SANET-ep) has completed a planned interim analysis. The IDMC determined that the study has already met the pre-defined primary endpoint of progression free survival (PFS) and as a result the study will be stopped.
Chi-Med will now arrange for a pre-New Drug Application (NDA) meeting with the China National Medical Products Administration (NMPA) to discuss the preparation of the NDA for surufatinib for this indication. They intend to submit the results of the SANET-ep study for presentation at an upcoming scientific conference.