Surufatinib Phase III SANET-ep study stopped early on meeting endpoints
Hutchison China MediTech (AIM: HCM), also known as Chi-Med, today announced that the independent Data Monitoring Committee (IDMC) of the Phase III pivotal 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 New Drug Application (NDA) for surufatinib for this indication. The company intends to submit the results of the SANET-ep study for presentation at an upcoming scientific conference.
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