Phase III Study of Surufatinib in Treating Advanced Extrapancreatic Neuroendocrine Tumors
Summary
A randomized, double-blind, placebo controlled, multi-center Phase III study to assess the efficacy of Surufatinib 300 mg once a day in treating advanced extrapancreatic neuroendocrine tumors.
Timeline
- Start
- 2015-12-07
- Primary completion
- 2019-03-31
- Completion
- 2022-07-07
Outcome
Met primary endpoint
paper surufatinib group versus 3·8 months (3·7-5·7) in the placebo group (hazard ratio 0·33; 95% CI 0·22-0·50; p<0·0001). PMID 32966811 ↗
release “(“SANET-ep”) has completed a planned interim analysis. The IDMC determined that the study has already met the pre-defined primary endpoint” hutch-med.com ↗
release “An interim analysis in June 2019 confirmed that the Phase III non-pancreatic NET (SANET-ep) study met its primary endpoint of progression-free survival (“PFS”).” hutch-med.com ↗
release “the SANET-ep Phase 3 study successfully met its primary endpoint of improved progression-free survival.” innoventbio.com ↗
release “SANET-ep demonstrated that surufatinib reduces risk of progression or death by 67%” hutch-med.com ↗
release “The study had met the pre-defined primary endpoint of progression-free survival (“PFS”) at a preplanned interim analysis.” hutch-med.com ↗
release “NCT02588170) in patients with advanced epNETs conducted in China. The study met the pre-defined primary endpoint” hutch-med.com ↗
release “NCT02588170) in patients with advanced epNETs conducted in China. The study met the pre-defined primary endpoint of PFS at a preplanned interim analysis” hutch-med.com ↗
release “SANET-ep study, a Phase III trial (clinicaltrials.gov identifier: NCT02588170) in patients with advanced epNETs conducted in China. The study met the pre-defined primary endpoint” hutch-med.com ↗
Publications
- Xu J, Shen L, Li J, Zhou Z, Bai C, Li Z, Chi Y, Li E, Yu X, Xu N, Bai Y, Wang X, Yuan X, Liu T, Yin Y, Chen J, Hu H, Li X, Xiu D, Zhang T, Lou W, Ying J, Qin S, Deng Y, Tao M, Cheng Y, Fan S, Luo X, Guo X, Shi MM, Su W. Surufatinib in advanced neuroendocrine tumours: Final overall survival from two randomised, double-blind, placebo-controlled phase 3 studies (SANET-ep and SANET-p). Eur J Cancer. 2025 Jun 3;222:115398. doi: 10.1016/j.ejca.2025.115398. Epub 2025 Mar 30.
- Li J, Cheng Y, Bai C, Xu J, Shen L, Li J, Zhou Z, Li Z, Chi Y, Yu X, Li E, Xu N, Liu T, Lou W, Bai Y, Yuan X, Wang X, Yuan Y, Chen J, Guan S, Fan S, Su W. Health-related quality of life in patients with advanced well-differentiated pancreatic and extrapancreatic neuroendocrine tumors treated with surufatinib versus placebo: Results from two randomized, double-blind, phase III trials (SANET-p and SANET-ep). Eur J Cancer. 2022 Jul;169:1-9. doi: 10.1016/j.ejca.2022.03.027. Epub 2022 Apr 28.
- Li J, Cheng Y, Bai C, Xu J, Shen L, Li J, Zhou Z, Li Z, Chi Y, Yu X, Li E, Xu N, Liu T, Lou W, Bai Y, Yuan X, Wang X, Yuan Y, Chen J, Guan S, Fan S, Su W. Treatment-related adverse events as predictive biomarkers of efficacy in patients with advanced neuroendocrine tumors treated with surufatinib: results from two phase III studies. ESMO Open. 2022 Apr;7(2):100453. doi: 10.1016/j.esmoop.2022.100453. Epub 2022 Mar 25.
- Xu J, Shen L, Zhou Z, Li J, Bai C, Chi Y, Li Z, Xu N, Li E, Liu T, Bai Y, Yuan Y, Li X, Wang X, Chen J, Ying J, Yu X, Qin S, Yuan X, Zhang T, Deng Y, Xiu D, Cheng Y, Tao M, Jia R, Wang W, Li J, Fan S, Peng M, Su W. Surufatinib in advanced extrapancreatic neuroendocrine tumours (SANET-ep): a randomised, double-blind, placebo-controlled, phase 3 study. Lancet Oncol. 2020 Nov;21(11):1500-1512. doi: 10.1016/S1470-2045(20)30496-4. Epub 2020 Sep 20.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Surufatinib | Small molecule | 300 mg | Oral |