Progression-free survival (PFS) with lanreotide autogel/depot (LAN) in enteropancreatic NETs patients: The CLARINET extension study.

4107^ Background: The CLARINET core study showed that the long-acting somatostatin analog (SSA) LAN 120 mg significantly prolonged PFS vs placebo (PBO) in patients (pts) with metastatic enteropancreatic NETs (p=0.0002). Median PFS not reached with LAN vs 18.0 months with PBO. This study was the first randomized PBO-controlled trial investigating PFS with an SSA in a population that included pts with pancreatic NETs and pts with grade G2 tumors (Ki-67 <10%). Here, we report PFS data and safety findings from the open-label extension (OLE) to CLARINET. Methods: Pts enrolled in CLARINEThad: well/moderately differentiated non-functioning enteropancreatic NETs with Ki-67 <10%; no prior SSAs, or other medical therapies in last 6 months; metastatic disease. In CLARINET, pts were randomized to LAN 120 mg (n=101) or PBO (n=103) every 28 days for 96 wks or until death/disease progression (PD; according to RECIST 1.0). LAN pts with stable disease and PBO pts with/without PD could then enter the single-arm (LAN) OLE (...