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Proffered Paper - NETs

1156O - Surufatinib (S) for patients (Pts) with advanced pancreatic neuroendocrine tumours (SANET-p): A randomized, double-blind, placebo (P)-controlled phase III trial (NCT02589821)

Date

20 Sep 2020

Session

Proffered Paper - NETs

Presenters

Jianming Xu

Citation

Annals of Oncology (2020) 31 (suppl_4): S711-S724. 10.1016/annonc/annonc281

Authors

J. Xu1, L. Shen2, C. Bai3, J. Li4, Z. Zhou5, X. Yu6, Z. Li7, E. Li8, X. Yuan9, Y. Chi10, Y. Yin11, W. Lou12, N. Xu13, Y. Bai14, T. Zhang15, D. Xiu16, X. Wang17, J. Li18, S. Fan18, 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 Gi Oncology, Peking University Cancer Hospital & Institute, Beijing/CN
  • 3 Department Of Oncology, Peking Union Medical College Hospital, 100071 - Beijing/CN
  • 4 Department Of Gi Oncology, Peking University Cancer Hospital & Institute, 100071 - Beijing/CN
  • 5 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
  • 6 Department Of Pancreatic And Hepatobiliary Surgery, Fudan University Shanghai Cancer Center, 200000 - Shanghai/CN
  • 7 Department Of Abdominal Oncology, West China Hospital, Sichuan University, 610041 - Chengdu/CN
  • 8 Department Of Medical Oncology, The First Affiliated Hospital of Xi’an Jiaotong University, 710061 - Xi'an/CN
  • 9 Department Of Oncology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, 430030 - Wuhan/CN
  • 10 National Cancer Center/cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, 100021 - Beijing/CN
  • 11 Department Of Oncology, The First Affiliated Hospital of Nanjing Medical University, 210029 - Nanjing/CN
  • 12 Department Of General Surgery, Zhongshan Hospital of Fudan University, 200032 - Shanghai/CN
  • 13 Department Of Medical Oncology, The First Affiliated Hospital of Zhejiang University, 310003 - Hangzhou/CN
  • 14 Department Of Gastrointestinal Oncology, Harbin Medical University Cancer Hospital, 150081 - Harbin/CN
  • 15 Cancer Centre, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, 430022 - Wuhan/CN
  • 16 Department Of General Surgery, Peking University Third Hospital, 100191 - Beijing/CN
  • 17 Department Of Medical Oncology, Qilu Hospital of Shandong University, 250012 - Jinan/CN
  • 18 Clinical Department And Regulatory Affairs, Hutchison MediPharma Limited, 200000 - Shanghai/CN
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Resources

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Abstract 1156O

Background

Surufatinib, a kinase inhibitor targeting vascular endothelial growth factor receptors, fibroblast growth factor receptor 1 and colony stimulating factor-1 receptor, has demonstrated superior efficacy in extra-pancreatic neuroendocrine tumors (NETs) in a prior phase III study (ESMO 2019 Abs. LBA76). Here we report results from a parallel study of surufatinib in pancreatic NETs (pNETs).

Methods

The study evaluated the efficacy and safety of S in Pts with well-differentiated (pathological grade 1 or 2), progressive, unresectable or metastatic pNETs. Pts were randomized in a 2:1 ratio to receive S or P, 300 mg, orally, once daily, until disease progression or intolerable adverse events. Crossover at disease progression was allowed. The primary endpoint was investigator-assessed progression-free survival (PFS).

Results

By the cutoff date on 11 November 2019 for the pre-planned interim analysis, 172 Pts were randomized, 113 pts to S and 59 to P. Baseline characteristics were well balanced. The study met the primary endpoint; investigator-assessed median PFS was 10.9 vs. 3.7 months in S and P arms, respectively, with hazard ratio (HR)=0.491; 95% confidence interval [CI]: 0.319–0.755; p=0.0011. Analysis by a blinded independent radiology committee confirmed PFS improvement (13.9 vs. 4.6 months; HR=0.339; 95% CI: 0.209–0.549; p<0.0001). The investigator-assessed objective response rate was 19.2% with S and 1.9% with P (p=0.0021). Most common (≥5% in either arm) grade ≥3 treatment-emergent adverse events (TEAEs) were hypertension (38.9% in S arm vs. 8.5% in P arm), proteinuria (9.7% vs. 1.7%), hypertriglyceridaemia (7.1% vs. 0), alanine aminotransferase increased and gamma-glutamyltransferase increased (both 2.7% vs. 5.1%). TEAEs leading to drug discontinuation occurred in 10.6% pts vs. 6.8% pts in S and P arm respectively.

Conclusions

Surufatinib significantly improved the PFS in Pts with progressive, well-differentiated advanced pNETs. The safety profile was manageable and consistent with observations in prior studies. Surufatinib represents a promising treatment option in the armamentarium against pNETs.

Clinical trial identification

NCT02589821.

Editorial acknowledgement

Legal entity responsible for the study

Hutchison MediPharma Limited.

Funding

Hutchison MediPharma Limited.

Disclosure

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

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