Final progression-free survival (PFS) analyses for lanreotide autogel/depot 120 mg in metastatic enteropancreatic neuroendocrine tumors (NETs): The CLARINET extension study.

4089Background: In the CLARINET core study, lanreotide Autogel (LAN) 120 mg deep sc monthly significantly improved PFS vs PBO in metastatic grade-1/2 enteropancreatic NETs. An interim analysis of patients with stable disease (SD) in the core study continuing LAN in the open-label extension (OLE, of which safety was primary objective) showed continued antitumor effects. Here, we report final LAN PFS analyses for subgroups according to tumor origin and prior therapy. Methods: In the core study, patients with metastatic well/moderately differentiated non-functioning (N-F) enteropancreatic NETs, Ki-67 <10%, no prior somatostatin-analog treatment and no other prior medical therapies in the previous 6 months were randomized to LAN 120 mg (n=101) or PBO (n=103) for 96 weeks or until death/progressive disease (PD; RECIST 1.0). Patients with SD receiving LAN and any patient receiving PBO could enter a single-arm (LAN) OLE (NCT00842348). Main efficacy endpoint: PFS (time from core-study randomization to death/PD) f...