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

Abstract

4089 Background: 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) for core-study intent-to-treat population from Kaplan–Meier survival analysis. Here, PFS was analyzed in subgroups of LAN–LAN patients. Results: OLE final population comprised 89 patients (LAN–LAN 42 [41 with SD]; PBO–LAN 47 [15 with SD]); 38% had pancreatic and 38% midgut NETs. During the OLE, 40% continuing LAN vs 47% switched to LAN had treatment-related adverse events. No new safety concerns were identified. Overall LAN median PFS from the LAN–LAN group was 38.5 months, and varied with tumor origin and prior therapy (Table). Conclusions: CLARINET OLE suggests sustained antitumor effects with LAN 120 mg in enteropancreatic NETs irrespective of tumor origin, and suggests benefits with LAN as early treatment. Clinical trial information: NCT00842348. [Table: see text]