- In patients with advanced pancreatic neuroendocrine tumours (pNETs), surufatinib treatment led to clinically meaningful improvements in PFS.
- The safety profile was tolerable.
- Surufatinib may be added to the armamentarium for treating well-differentiated pNETs.
Why this matters
- New effective therapeutic options are needed for patients with progressive advanced pNET.
- Randomized, double-blind, placebo-controlled trial (SANET-p).
- Patients in China with progressive, advanced pNET were randomly allocated to surufatinib (300 mg orally, once daily) or placebo until progression or intolerable adverse events.
- Primary endpoint: investigator-assessed PFS.
- Secondary endpoints: objective response rate (ORR), disease control rate, duration of response, time to response, OS.
- Funding: Hutchison MediPharma Limited.
- 172 patients included in the preplanned interim analysis (surufatinib n=113; placebo n=59).
- Median PFS: 10.9 months with surufatinib vs 3.7 months with placebo.
- HR, 0.491 (P=.0011).
- PFS by a blinded Independent Image Review Committee (BIIRC):
- 13.9 months with surufatinib vs 4.6 months with placebo.
- HR, 0.339 (P=.0001).
- PFS benefit favored surufatinib across major subgroups and improvements.
- ORR: 19.2% with surufatinib vs 1.9% with placebo (P=.0021).
- OS data still immature (16.9% events).
- Hypertension was the most common grade 3 or higher treatment-emergent adverse event (TEAE): 38.9% with surufatinib vs 8.5% with placebo.
- TEAEs leading to dose reduction: 38.9% with surufatinib vs 5.1% with placebo.
- TEAEs leading to dose discontinuation: 10.6% with surufatinib vs 6.8% with placebo.
“A proportion of patients in SANET-p had previously received everolimus. SANET-p provides the first evidence in a phase 3 trial that a TKI is effective after progression on an mTOR inhibitor," said Nicola Fazio, director, Gastrointestinal and Neuroendocrine Cancer Medical Treatment, European Institute of Oncology, Milan, Italy, who was not involved with the study.
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