Efficacy and safety of [177Lu]Lu-edotreotide vs. everolimus in patients with grade 1 or grade 2 gastroenteropancreatic neuroendocrine tumours: COMPETE phase 3 trial

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Introduction: Patients with metastatic gastroenteropancreatic neuroendocrine tumours (GEP-NET) have limited therapeutic options.

Aim(s): The Phase 3 COMPETE trial evaluated the efficacy and safety of [177Lu]Luedotreotide vs. everolimus in patients with WHO grade 1 or grade 2 GEP-NET. This is the first trial comparing a targeted radiopharmaceutical therapy ([177Lu]Lu-edotreotide) with a targeted molecular therapy (everolimus) in this setting.

Materials and methods: Patients (aged ≥18 years) with grade 1 or grade 2 inoperable, progressive, somatostatin receptor-positive GEP-NET (Ki-67 ≤20%) were randomised (2:1) to receive maximum 4 cycles (7.5 GBq/cycle) of [177Lu]Lu-edotreotide every 12 weeks, or until disease progression vs. 10 mg everolimus daily up to 30 months, or until disease progression. The primary endpoint was progression-free survival (PFS) per RECIST 1.1 criteria analysed by Blinded Independent Central Review (BICR). Secondary endpoints included objective response rate, overall survival, safety, and quality of life.

Conference:

Presenting Author:

Authors: Capdevila J, Amthauer H, Ansquer C, Deshayes E, Garcia-Carbonero R,

Keywords: radiopharmaceutical therapy, neuroendocrine tumour, [177Lu]Lu-edotreotide, progression-free survival, gastroenteropancreatic,