Hutchison China MediTech (Chi-Med) announced that the Independent Data Monitoring Committee (IDMC) of the Phase III pivotal study of surufatinib in advanced neuroendocrine tumours – pancreatic (SANET-p) has completed a pre-planned interim analysis. The IDMC recommended that the study stops early as the pre-defined primary endpoint of progression free survival (PFS) had already been met.
Presently, Chi-Med plans to arrange 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.
The CEO of Chi-Med, said: “Following surufatinib’s NDA submission for the treatment of non-pancreatic neuroendocrine tumours, these positive results for pancreatic neuroendocrine tumours reinforce that surufatinib has the unique opportunity to address all advanced neuroendocrine tumours. We believe that no targeted therapies are approved in China or globally for such a broad spectrum of neuroendocrine tumour disease.”