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演示文稿, 科學出版物 | 2020-09-20

ESMO2020: 索凡替尼治療晚期胰腺神經內分泌瘤患者(SANET-p)

標題: 索凡替尼治療晚期胰腺神經內分泌瘤患者(SANET-p):隨機、雙盲、安慰劑對照的III期臨床試驗 (NCT02589821)
主要作者: 中國人民解放軍總醫院第五醫學中心 消化腫瘤科主任 徐建明
會議環節: 口頭報告 – 神經內分泌瘤
摘要編號: 1156O
日期和時間: 2020年9月20日(星期日)中歐夏令時間(CEST)下午2:25
會場: Channel 3

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.

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.