Exp Clin Endocrinol Diabetes 2015; 123 - P14_04
DOI: 10.1055/s-0035-1547777

Antitumor activity of lanreotide autogel (LAN) in enteropancreatic net patients: The CLARINET open-label extension (OLE) study

M Pavel 1, M Caplin 2, JB Ćwikła 3, A Phan 4, M Raderer 5, E Sedláčková 6, G Cadiot 7, E Wolin 8, J Capdevila 9, L Wall 10, G Rindi 11, A Langley 12, E Gomez-Panzani 12, P Ruszniewski 13
  • 1Medizinische Klinik für Hepatologie und Gastroenterologie (Einschl. Arbeitsbereich Stoffwechselerkrankungen); Charité – Universitätsmedizin; Campus Virchow Klinikum
  • 2Royal Free Hospital
  • 3University of Varmia and Masuria
  • 4Houston Methodist Hospital Cancer Center
  • 5University Hospital Vienna
  • 6First Faculty of Medicine and General Teaching Hospital
  • 7Robert-Debré Hospital
  • 8Markey Cancer Center
  • 9Vall D'hebron University Hospital and Vall D'hebron Institute of Oncology
  • 10Western General Hospital
  • 11Università Cattolica del Sacro Cuore
  • 12Ipsen Pharma
  • 13Hôpital Beaujon Service de Gastroentérologie

Background: CLARINET core study data has demonstrated the efficacy and safety/tolerability of LAN 120 mg as an antitumor treatment in patients with metastatic enteropancreatic NETs. Here, we report updated PFS data and safety findings from the CLARINET OLE (NCT00842348).

Methods: In the core study, patients with metastatic well/moderately differentiated non-functioning enteropancreatic NETs, Ki-67 < 10%, no prior medical therapy in last 6 months were randomized to LAN 120 mg (n = 101) or placebo (n = 103) for 96 weeks or until progressive disease (PD)/death. In the OLE, patients with stable disease (SD) at core-study end or progressive disease (PD) on core-study placebo entered single-arm OLE on LAN 120 mg. The primary objective was to evaluate longer-term safety of LAN; a secondary objective was to investigate further LAN efficacy based on PFS (i.e. time from randomization in core study to PD/death) for the core study intent-to-treat population, using survival analysis based on Kaplan-Meier estimates.

Results: 88 patients from the core-study (41 on LAN, 47 on placebo) entered the OLE. At core-study enrolment, 96% of OLE patients had SD; 38% had pancreatic and 39% midgut primary tumours. For patients continuing on LAN, median PFS reached during the OLE was 32.8 months [95%CI: 30.9 – 68.0]. For patients who switched from PBO to LAN after PD in the core study, median time to further PD with LAN in the OLE was 14.0 months. During the OLE, 66% who continued LAN vs. 81% who switched to LAN experienced adverse events (of which, 27% vs. 40% were treatment-related; most frequent events were diarrhea. No new safety concerns were identified during the OLE.

Conclusions: The OLE study further demonstrates favourable LAN safety/tolerability in enteropancreatic NETs. It also provides data on the continued antitumor effects in patients with SD on LAN in the core study, and on antitumor effects in patients after PD with placebo.