KEY TAKEAWAYS
- The SANET-p trial was a phase III investigation of Surufatinib’s effects on pancreatic neuroendocrine tumors.
- The primary aim was to evaluate the effectiveness and safety of Surufatinib (S) compared to placebo (P) in patients with well-differentiated, progressive, unresectable, or metastatic pNETs.
- Patients were randomly assigned in a ratio of 2:1 to receive either S or P orally at a dose of 300 mg once daily until disease progression or intolerable adverse events.
- The clinical trial achieved its primary endpoint, with a statistically significant median PFS of 10.9 months in the S group compared to 3.7 months in the P group.
- Prevalent grade ≥3 TEAEs with a frequency of ≥5% in either arm were hypertension, proteinuria, hypertriglyceridemia, and alanine aminotransferase increased.
- Surufatinib effectively improved PFS among patients diagnosed with progressive, well-differentiated advanced pNETs, with a manageable and consistent safety profile.
Surufatinib (S), a kinase inhibitor that specifically targets vascular endothelial growth factor receptors, fibroblast growth factor receptor 1, and colony-stimulating factor-1 receptor, has exhibited exceptional effectiveness in the treatment of extra-pancreatic neuroendocrine tumors (NETs) in a previous phase III investigation (ESMO 2019 Abs. LBA76). A report presented findings from a parallel investigation of surufatinib’s effects on pancreatic neuroendocrine tumors (pNETs). It assessed the effectiveness and security of S in patients diagnosed with well-differentiated (pathological grade 1 or 2), progressive, unresectable or metastatic pancreatic neuroendocrine tumors (pNETs). The patients were randomly assigned in a ratio of 2:1 to receive either S or P, administered orally at a dose of 300 mg once daily until the occurrence of disease progression or the onset of intolerable adverse events.
Crossing over during the course of disease progression was permitted. The principal objective was the evaluation of progression-free survival (PFS) as assessed by the investigator. Until the predetermined interim analysis deadline of November 11th, 2019, 172 patients were subject to randomization, with 113 patients receiving treatment S and 59 patients receiving treatment P. The baseline characteristics were adequately equilibrated. The clinical trial achieved its primary endpoint, with a median progression-free survival (PFS) of 10.9 months in the study group compared to 3.7 months in the placebo group, as assessed by the investigators. The hazard ratio (HR) was 0.491, with a 95% confidence interval (CI) of 0.319-0.755 and a P= 0.0011. The blinded independent radiology committee’s analysis has confirmed an improvement in progression-free survival (PFS) with a statistically significant hazard ratio of 0.339 (95% CI: 0.209–0.549; P<0.0001).
The PFS improvement was observed for 13.9 months compared to 4.6 months. The objective response rate assessed by the investigator was 19.2% when treated with S and 1.9% when treated with P (P=0.0021). The prevalent grade ≥3 treatment-emergent adverse events (TEAEs) with a frequency of ≥5% in either arm were hypertension (38.9% in the S arm vs. 8.5% in the P arm), proteinuria (9.7% vs. 1.7%), hypertriglyceridemia (7.1% vs. 0), alanine aminotransferase increased, and gamma-glutamyltransferase increased (both 2.7% vs. 5.1%). The incidence of treatment-emergent adverse events resulting in drug discontinuation was 10.6% in the study group and 6.8% in the placebo group. The administration of Surufatinib significantly improved progression-free survival among patients diagnosed with progressive, well-differentiated advanced pancreatic neuroendocrine tumors. The safety profile exhibited manageability and consistency with prior study observations. Surufatinib exhibits potential as a promising therapeutic alternative in the armamentarium against pancreatic neuroendocrine tumors (pNETs).
Source:https://oncologypro.esmo.org/meeting-resources/esmo-virtual-congress-2020/surufatinib-s-for-patients-pts-with-advanced-pancreatic-neuroendocrine-tumours-sanet-p-a-randomized-double-blind-placebo-p-controlled-ph
Clinical Trial:https://clinicaltrials.gov/ct2/show/NCT02589821
J. Xu, L. Shen, C. Bai, J. Li, Z. Zhou, X. Yu, Z. Li, E. Li, X. Yuan, Y. Chi, Y. Yin, W. Lou, N. Xu, Y. Bai, T. Zhang, D. Xiu, X. Wang, J. Li, S. Fan, W. Su/Surufatinib (S) for patients (Pts) with advanced pancreatic neuroendocrine tumors (SANET-p): A randomized, double-blind, placebo (P)-controlled phase III trial (NCT02589821)/Annals of Oncology (2020) 31 (suppl_4): S711-S724. 10.1016/annonc/annonc281
