Hutchison China MediTech Limited ("Chi-Med") (AIM: HCM) today announces that Hutchison MediPharma Limited ("HMP"), its drug R&D subsidiary, has initiated SANET-ep, a Phase III sulfatinib (HMPL-012) registration trial in China in patients with extra-pancreatic neuroendocrine tumors ("NETs"), which are all non-pancreatic NETs, including, for example, NETs originating in the lymph, lung and across the gastrointestinal tract. Preparations and site selection had begun in the middle of this year and the first patient was dosed on December 17, 2015.
SANET-ep is a randomized, double-blind, placebo-controlled, multi-center Phase III sulfatinib registration study to treat pathologically low or intermediate grade NET patients whose disease has progressed, locally advanced or distant metastasized and for whom there is no effective therapy. Patients will be randomized at a 2:1 ratio to receive either 300 milligrams of sulfatinib orally once per day, or placebo, on every 28-day treatment cycle. The primary objective of this study is to evaluate the progression-free survival of sulfatinib as compared to that of placebo, with secondary endpoints including objective response rate ("ORR"), disease control rate, time to response, duration of response, overall survival, safety and tolerability. Approximately 270 patients will be enrolled in the SANET-ep study from more than 20 centers across China, with top-line results expected in 2018.
Additionally, the second Phase III sulfatinib registration trial, SANET-p, in pancreatic NET patients, is expected to be initiated imminently in China. SANET-p employs a similar treatment regimen and has primary and secondary endpoints similar to those for SANET-ep trial. Approximately 195 patients will be enrolled in SANET-p and is expected to start by the end of 2015, with top-line results expected in 2017.