CLARINET FORTE: Characterization of Pharmacokinetics (PK), efficacy and safety in patients with progressive neuroendocrine tumors (NETs) treated with Lanreotide Autogel (LAN) 120 mg every 14 days (q14d)

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Introduction: CLARINET FORTE investigated efficacy and safety of LAN 120 mg q14d (frequent dose) in patients with pancreatic (panNET) or midgut NETs after progression while on LAN 120 mg every 28 days (q28d; standard dose) (NCT02651987).

Aim(s): To analyse the PK of LAN 120 mg q14d in relation to efficacy; and to explore the relationship between LAN exposure and adverse events of interest (glycoregulation disorder, cholelithiasis, hypertension), using data pooled with prior studies.

Materials and methods: LAN 120 mg q14d was administered for 48 (panNET; n=48) or 96 (midgut NET; n=51) weeks. LAN serum concentration was assessed at baseline and weeks 12, 24, 48, and 96 (midgut only). Progression free survival (PFS) was assessed every 12 weeks from week 12. PK was analysed in relation to PFS in CLARINET FORTE population only (n=99). For PK and safety evaluations, data from previous studies in NET were included (n=519; dose range 60–120 mg, q28d–q14d).

Conference: 18th Annual ENETS Concerence (2021)

Presenting Author:

Authors: Dehez M, Brendel K, Sarr C, Björnsson M, Truong Thanh X,

Keywords: NET, PK, PFS, tumor size, safety, somatostatin analogues, high dose,