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Proffered Paper – NETs and endocrine tumours

4979 - Efficacy and safety of surufatinib in patients with well-differentiated advanced extrapancreatic neuroendocrine tumors (NETs): results from the randomized phase III study (SANET-ep)


29 Sep 2019


Proffered Paper – NETs and endocrine tumours


Tumour Site

Neuroendocrine Neoplasms


Jianming Xu


Annals of Oncology (2019) 30 (suppl_5): v851-v934. 10.1093/annonc/mdz394


J. Xu1, L. Shen2, Z. Zhou3, J. Li2, C. Bai4, Y. Chi5, Z. Li6, N. Xu7, R. Jia1, E. Li8, T. Liu9, Y. Bai10, Y. Yuan11, X. Li12, X. Wang13, J. Chen14, J. Ying15, J. Li16, S. Fan17, W. Su18

Author affiliations

  • 1 Department Of Gastrointestinal Oncology, The Fifth Medical Center, General Hospital of the People's Liberation Army, 100071 - Beijing/CN
  • 2 Department Of Gastrointestinal Oncology, Key Laboratory Of Carcinogenesis And Translational Research (ministry Of Education), Peking University Cancer Hospital & Institute, 100142 - Beijing/CN
  • 3 Department Of Gastric Surgery, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, 510060 - Guangzhou/CN
  • 4 Department Of Oncology, Peking Union Medical College Hospital, 100730 - Beijing/CN
  • 5 Department Of Medical Oncology, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, 100021 - Beijing/CN
  • 6 Department Of Abdominal Oncology, West China Hospital, Sichuan University, 610041 - Chengdu/CN
  • 7 Department Of Medical Oncology, The First Affiliated Hospital of Zhejiang University, 310003 - Hangzhou/CN
  • 8 Department Of Medical Oncology, The First Affiliated Hospital of Xi’an Jiaotong University, 710061 - Xi'an/CN
  • 9 Department Of Oncology, Zhongshan Hospital of Fudan University, 200032 - Shanghai/CN
  • 10 Department Of Gastrointestinal Oncology, Harbin Medical University Cancer Hospital, 150081 - Harbin/CN
  • 11 Department Of Medical Oncology, The Second Affiliated Hospital, Zhejiang University School of Medicine, 310009 - Hangzhou/CN
  • 12 Department Of Medical Oncology, The First Affiliated Hospital of Zhengzhou University, 450000 - Zhengzhou/CN
  • 13 Department Of Medical Oncology, Qilu Hospital of Shandong University, 250012 - Jinan/CN
  • 14 Department Of Oncology, Jiangsu Cancer Hospital, Nanjing/CN
  • 15 Department Of Abdominal Oncology, Zhejiang Cancer Hospital, Hangzhou/CN
  • 16 Clinical Development And Regulatory Affairs, Hutchison MediPharma Ltd, 201203 - Shanghai/CN
  • 17 Clinical Development And Regulatory Affairs, Hutchison MediPharma Ltd, Shanghai/CN
  • 18 Clinical Development And Regulatory Affairs/chemistry, Hutchison MediPharma Ltd, Shanghai/CN


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Abstract 4979


Surufatinib (HMPL-012, previously named sulfatinib) is a small-molecule kinase inhibitor targeting vascular endothelial growth factor receptors, fibroblast growth factor receptor 1 and colony stimulating factor 1 receptor, which demonstrated encouraging efficacy in previous Phase Ib/II study in patients with advanced NETs regardless of tumor origin.


This was a randomized, double-blind, multi-center phase III study to evaluate efficacy and safety of surufatinib in patients with well-differentiated, progressive, unresectable or metastatic extrapancreatic NETs (NCT02588170). Eligible patients were randomized in a 2:1 ratio to receive surufatinib or placebo, 300 mg, orally, once daily, until disease progression or intolerable adverse events. Crossover at disease progression was allowed. The primary endpoint was disease progression-free survival (PFS) assessed by investigators.


By the cutoff date on 31 March 2019 for the pre-planned interim analysis, 198 patients were randomized (surufatinib: N = 129, placebo N = 69) with 128 PFS events observed. The tumor origins included gastrointestinal tract (47.0%), lung (11.6%), other (27.8%) or unknown (13.6%). Most patients (83.8%) were with NETs of pathological grade 2. Investigator-assessed median PFS was 9.2 vs. 3.8 months in surufatinib and placebo arms (hazard ratio [HR] = 0.334 [95% confidence interval [CI] 0.223, 0.499]; p < 0.0001), respectively. A trend of PFS prolongation (HR = 0.657, 95% CI 0.442, 0.977) was observed by the independent radiology committee. Overall survival (OS) was immature at data cutoff (18.7% OS events). Most common (≥5%) grade 3 or worse treatment-emergent adverse events were hypertension (36.4% in surufatinib arm vs. 13.2% in placebo arm), proteinuria (19.4% vs. 0%) and anemia (7.0% vs. 2.9%).


Surufatinib significantly improved the PFS in patients with progressive, advanced NETs originating outside of pancreas. No new safety signals were identified. The study was terminated by the recommendation of the Independent Data Monitoring Committee based on the interim analysis. A parallel study of surufatinib in pancreatic NETs is ongoing.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

Hutchison MediPharma Ltd.


Hutchison MediPharma Ltd.


J. Li: Full / Part-time employment: Hutchison MediPharma Ltd. S. Fan: Full / Part-time employment: Hutchison MediPharma Ltd. W. Su: Leadership role, Shareholder / Stockholder / Stock options, Full / Part-time employment: Hutchison MediPharma Ltd. All other authors have declared no conflicts of interest.

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