IDMC recommends early halt of phase III SANET-p study of HMPL 012 in neuroendocrine tumors – pancreatic.- Hutchison China MediTech

Hutchison China MediTech Limited announced that the independent Data Monitoring Committee of the Phase III pivotal study of HMPL 012 (surufatinib) in advanced neuroendocrine tumors – 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 had already been met. Following the early success of this study, Chi-Med now plans to arrange 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. Chi-Med intends to submit the results of the SANET-p study for presentation at an upcoming scientific conference. Comment: SANET-p is a Phase III study in China of surufatinib in patients with low-grade or intermediate-grade advanced pancreatic neuroendocrine tumor 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.