Status of the ongoing SORENTO clinical trial: Assessing efficacy and safety of high-exposure octreotide subcutaneous depot in patients with GEP-NET

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Introduction: Somatostatin receptor ligands (SRLs) are first-line standard of care therapies for gastroenteropancreatic neuroendocrine tumors (GEP-NET). Retrospective data suggest higher-dose SRLs may benefit patients with GEP-NET.

Aim(s): The aim of this clinical trial is to confirm efficacy/safety of a long-acting, high-exposure formulation octreotide subcutaneous depot (CAM2029), versus octreotide LAR and lanreotide Autogel (ATG).

Materials and methods: SORENTO (NCT05050942) is a randomised, multicentre, open-label, active-controlled phase 3 trial, aiming to enrol 302 patients with GEP-NET. Key eligibility criteria: advanced, well-differentiated NET of GEP/presumed GEP origin; ≥1 measurable somatostatin receptor-positive lesion; no/<6 months consecutive treatment with SRLs. Patients will be randomized 1:1 to CAM2029 20mg every two weeks or active comparator (octreotide LAR 30mg or lanreotide ATG 120mg, every four weeks). Randomization stratified by histological grade; tumor origin; intended comparator. The primary outcome is progression free survival (PFS) assessed by a Blinded Independent Review Committee. The study is powered to detect a 0.65 hazard ratio. Patients experiencing progressive disease may enter an open-label extension with weekly CAM2029 20 mg. Readout will occur following 194 PFS events. If the primary endpoint is met, the comparator group may switch to CAM2029. After primary PFS analysis, overall survival will be followed for up to 2 years.

Conference:

Presenting Author: Singh S

Authors: Singh S, Capdevila J, Ang Chan J, de Herder W, Grozinsky-Glasberg S,

Keywords: CAM2029, GEP-NET, high plasma exposure, octreotide, randomised active-controlled, somatostatin receptor ligands, SORENTO,