KEY TAKEAWAYS
- The phase 3 SANET-p trial evaluated the effectiveness and safety of Surufatinib in patients with advanced pancreatic NETs.
- The primary aim was to evaluate the PFS of patients receiving Surufatinib compared to placebo.
- The study found that patients who received Surufatinib had a significantly longer PFS than those who received a placebo.
- The most common grade 3 or higher treatment-associated adverse events for patients receiving Surufatinib were hypertension, proteinuria, and hypertriglyceridemia.
- The SANET-p study demonstrated that Surufatinib is an effective treatment option for individuals with advanced pancreatic neuroendocrine tumors, with a favorable safety profile.
The phase 3 SANET-ep study demonstrated that Surufatinib exhibited superior efficacy in extrapancreatic neuroendocrine tumors (NETs). The study’s objective was to evaluate the effectiveness and safety of surufatinib in patients diagnosed with advanced pancreatic NETs. The SANET-p was a randomized, double-blind, and placebo-controlled study conducted in 21 medical facilities throughout China. Adult patients aged 18 years or older who have progressive, advanced, well-differentiated pancreatic neuroendocrine tumors (NETs), Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and have experienced progression on up to two prior systemic regimens for advanced disease were considered eligible. The study randomly allocated patients (2:1) to receive 300 mg of surufatinib or a placebo through an interactive web response system. The medication was administered orally once daily in consecutive 4-week treatment cycles until the occurrence of disease progression, intolerable toxicity, withdrawal of consent, poor compliance, use of other antitumor medication, pregnancy, loss to follow-up, or if discontinuation was deemed to be in the patient’s best interest by the investigator. Central randomization was performed utilizing stratified block randomization (block size of three), stratified by pathological grade, previous systemic antitumor therapy, and ECOG performance status score. The treatment allocation was concealed from patients, investigators, research staff, and the sponsor study team. Patients in the placebo cohort with disease progression were authorized to transition to surufatinib therapy. The principal objective was to evaluate the progression-free survival assessed by the investigator in the intention-to-treat cohort, comprising all randomized patients. A pre-planned interim analysis was conducted upon reaching 70% of the predicted progression-free survival events.
During the period spanning from February 18th, 2016, to November 11th, 2019, a total of 264 patients underwent screening. Of these patients, 172 individuals, accounting for 65% of the total, were randomly selected to receive either surufatinib (n=113) or placebo (n=59). The median follow-up duration was 19.3 months (95% CI 9.3-19.4) for the surufatinib group and 11.1 months (5.7-35.9) for the placebo group. The investigator-assessed progression-free survival median was 10.9 months (7.5-13.8) for surufatinib compared to 3.7 months (2.8-5.6) for placebo. The hazard ratio was 0.49, with a 95% confidence interval of 0.32-0.76 and a P-value of 0.0011. The clinical trial satisfied the predetermined conditions for early termination during the interim analysis and was consequently halted based on the advice of the autonomous data monitoring committee. The prevalent grade 3 or higher treatment-associated unfavorable occurrences included hypertension (observed in 43 [38%] out of 113 patients receiving surufatinib versus four [7%] out of 59 patients receiving placebo), proteinuria (observed in 11 [10%] versus one [2%]), and hypertriglyceridemia (observed in eight [7%] versus none). Twenty-five (22%) patients in the surufatinib group and four (7%) patients in the placebo group reported serious adverse events related to treatment. The surufatinib group experienced three deaths while under treatment. Among these, two were caused by adverse events, namely gastrointestinal hemorrhage and cerebral hemorrhage, while one was attributed to disease progression. A single mortality event occurred in the placebo cohort during treatment, ascribed to the advancement of the underlying ailment.
Source:https://pubmed.ncbi.nlm.nih.gov/32966810/
Clinical Trail:https://clinicaltrials.gov/ct2/show/NCT02589821
Xu J, Shen L, Bai C, Wang W, Li J, Yu X, Li Z, Li E, Yuan X, Chi Y, Yin Y, Lou W, Xu N, Bai Y, Zhang T, Xiu D, Wang X, Yuan Y, Chen J, Qin S, Jia R, Lu M, Cheng Y, Zhou Z, Li J, He J, Su W. Surufatinib in advanced pancreatic neuroendocrine tumors (SANET-p): a randomized, double-blind, placebo-controlled, phase 3 study. Lancet Oncol. 2020 Nov;21(11):1489-1499. doi: 10.1016/S1470-2045(20)30493-9. Epub 2020 Sep 20. PMID: 32966810.
