{"entity":{"id":"sanet","kind":"trial","name":"SANET-ep and SANET-p","aka":[],"tldr":"In the SANET trials, a Chinese anti-angiogenic pill slowed both gut and pancreatic neuroendocrine tumours, but its US application was refused.","summary":"SANET-ep and SANET-p, led by trial NCT02588170 and sponsored by Hutchmed, showed in 2020 that the Chinese anti-angiogenic tablet surufatinib slows both extra-pancreatic and pancreatic neuroendocrine tumours, but its US application was refused. The two trials randomised 198 patients with extra-pancreatic and 172 with pancreatic progressive tumours to surufatinib or placebo in China, and both met their primary progression-free survival endpoints with large effects, leading to approval in China in 2020 and 2021, while the FDA issued a complete response letter in 2022 requiring a multiregional trial. OnCo links them to neuroendocrine tumours, anti-angiogenic therapy and VEGF and VEGFR as targets. Whether a single-country trial can ever support a US approval is the wider question the refusal raised.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT02588170","url":"https://clinicaltrials.gov/study/NCT02588170"}],"tags":["lesson:single-region-data"],"related":[],"cancers":["neuroendocrine"],"sections":[],"technologies":["antiangiogenic"],"targets":["vegf"],"drugs":["surufatinib"],"companies":["hutchmed"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02588170","phase":"3","setting":"Progressive extra-pancreatic (n=198) and pancreatic (n=172) NETs: surufatinib vs placebo (China)","sponsor":"Hutchmed","result":"PFS HR 0.33 (ep), 0.49 (p).","started":"2015-12-07","startedType":"actual","yearReported":2020,"enrolled":369,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival (SANET-ep)","primary":true,"unit":"months","arms":[{"name":"Surufatinib","value":9.2},{"name":"Placebo","value":3.8}],"hr":0.33,"source":"https://doi.org/10.1016/S1470-2045(20)30496-4"},{"endpoint":"Progression-free survival (SANET-p)","primary":true,"unit":"months","arms":[{"name":"Surufatinib","value":10.9},{"name":"Placebo","value":3.7}],"hr":0.49,"source":"https://doi.org/10.1016/S1470-2045(20)30493-9"}]},"route":"/trials/sanet/","neighbours":{"cancer":[{"id":"neuroendocrine","kind":"cancer","name":"Neuroendocrine tumours","route":"/cancers/neuroendocrine/"}],"technology":[{"id":"antiangiogenic","kind":"technology","name":"Anti-angiogenic therapy","route":"/technologies/antiangiogenic/"}],"target":[{"id":"vegf","kind":"target","name":"VEGF / VEGFR","route":"/targets/vegf/"}],"drug":[{"id":"surufatinib","kind":"drug","name":"Surufatinib","route":"/drugs/surufatinib/"}],"company":[{"id":"hutchmed","kind":"company","name":"Hutchmed","route":"/companies/hutchmed/"}]}}