COMPOSE: Phase III trial of 177Lu-edotreotide versus standard of care in well-differentiated (WD) aggressive grade 2 and grade 3 gastroenteropancreatic neuroendocrine tumors (GEP-NETs)

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Introduction: Therapeutic algorithm for well-differentiated (WD) high-grade 2 and grade 3 gastroenteropancreatic neuroendocrine tumors (G2 + G3 GEP-NETs) is not well established. Current ‘best standard of care’ include CAPTEM, FOLFOX and everolimus. Peptide Receptor Radionuclide Therapy (PRRT) could be useful in high grade NETs, however there is a lack of prospective evidence. 177Lu-edotreotide is an innovative radiolabeled somatostatin analogue with a favourable safety profile and efficacy. The ongoing Phase III trial COMPETE in G1 and G2 GEP-NETs is exploring the efficacy and safety of 177Lu-edotreotide, in comparison to everolimus.

Aim(s): COMPOSE is a complementary study with the aim of extending the therapeutic options for 177Lu-edotreotide to high grade NETs.

Materials and methods: COMPOSE (NCT04919226) is a prospective, randomized, controlled, open-label, multi-center Phase III study to evaluate efficacy, safety and patient-reported outcomes of first- or later-line treatment with up to 6 cycles of 7.5 GBq of 177Lu-edotreotide PRRT compared to standard of care (CAPTEM, FOLFOX or everolimus) in 202 patients with WD G2 and G3 (Ki-67 index 15−55), SSTR+, GEP-NETs, randomized 1:1. Primary endpoint is progression free survival, assessed every 12 weeks until disease progression (RECIST v1.1) or death. Secondary outcomes include overall survival, assessed up to 2 years after disease progression.

Conference:

Presenting Author:

Authors: Hernando J, Halfdarnarson T, Halperin D, Reidy-Lagunes D, Kong G,

Keywords: neuroendocrine, NET, 177Lu-edotreotide, PRRT,