Multicenter phase 2 study of ramucirumab plus somatostatin analog therapy for advanced neuroendocrine tumors

Well-differentiated neuroendocrite tumors (NET) are highly vascular tumors characterized by their expression of vascular endothelial growth factor (VEGF). A phase 2 trial at four centers in Boston (MA) evaluated the activity of ramucirumab, a monoclonal antibody that targets VEGF receptor-2 and inhibits activity of VEGF, in combination with somatostatin analog therapy in patients with advanced extra-pancreatic NET. The primary endpoint was progression-free survival; overall survival was a secondary endpoint. The median progression-free survival and overall survival were 14.2 months (95% CI 9.0-25.6) and 24.9 months (20.7-43.1), respectively. Most common all-grade adverse events were fatigue (84%; grade 3: 35%) and hypertension (84%; grade 2: 12%). The authors conclude that ramucirumab in combination with somatostatin analog therapy demonstrated efficacy and safety in patients with advanced extrapancreatic NET.