NANETS2022 15th Annual Multidisciplinary NET Medical Symposium NANETS 2022 Trials In Progress (10 abstracts)
COMPOSE: Pivotal Phase III Trial for Well-Differentiated Aggressive Grade 2/3 Gastroenteropancreatic Neuroendocrine Tumors Comparing 177Lu-edotreotide with Best Standard of Care
Thorvardur R Halfdanarson 1 , Daniel M Halperin 2 , Diane Reidy-Lagunes 3 , Grace Kong 4 , Jaume Capdevila 5 , Josh Mailman 6 , Ken Herrmann 7 , Rajaventhan Srirajaskanthan 8 , Simone Leyden 9 , Thomas Thevenet 10 & Philip Harris 10
1Mayo Clinic, Rochester, MN USA; 2MD Anderson Cancer Center, Houston, Texas, USA; 3Memorial Sloan Kettering Cancer Center, New York, USA; 4Peter MacCallum Cancer Centre, Melbourne, VIC, Australia; 5Vall d´Hebron University Hospital, Vall d´Hebron Institute of Oncology, Barcelona, Spain; 6NorCal CarciNET Community, Oakland, CA; 7University Hospital Essen, Germany; 8Kings College Hospital, London, UK; 9NeuroEndocrine Cancer Australia, Victoria, Australia; 10ITM Oncologics GmbH, Garching/Munich, Germany.
Background: Gastroenteropancreatic neuroendocrine tumors (GEP-NETs), which frequently develop metastatic disease, represent an estimated 70% of NETs. There are limited treatment options with current standard therapies for well-differentiated aggressive grade 2 and grade 3 (Ki-67 index 15−55%) GEP-NETs; however, these may include somatostatin analogues; peptide receptor radionuclide therapy (PRRT); molecular targeted therapies (everolimus or sunitinib); chemotherapy; and cytoreductive procedures. PRRT, which uses radiolabeled somatostatin analogues to selectively target somatostatin receptor expressing tumor cells, may stabilize disease and induce objective tumor responses. The radiolabeled somatostatin analogue 177Lu-edotreotide has demonstrated promising efficacy and a favorable safety profile. Retrospective data in metastatic GEP-NETs treated with two or more 177Lu-edotreotide cycles demonstrated nearly 30 months progression free survival (PFS). COMPOSE (NCT04919226), a prospective, randomized, controlled, open-label, multi-center Phase III study, aims to extend therapeutic options for patients with well-differentiated aggressive grade 2 and grade 3, SSTR+, GEP-NETs.
Methods: COMPOSE evaluates efficacy, safety, and patient-reported outcomes of first- or second-line treatment with 177Lu-edotreotide PRRT. At least 202 patients with somatostatin receptor-positive (SSTR+) disease will be randomized 1:1 to up to six cycles of 177Lu-edotreotide, given at 6- to 8-week intervals, or to an active comparator (either chemotherapy [CAPTEM or FOLFOX] or everolimus, according to investigatoŕs choice). PFS, the primary endpoint, will be assessed every 12 weeks until disease progression (RECIST v1.1) or death, whichever occurs earlier. Overall survival, assessed up to 2 years after disease progression, is a secondary outcome.
Results: COMPOSE recruitment commenced in September 2021 and currently includes 29 open sites in Australia, France, India, Italy, the Netherlands, Spain, Sweden, the United Kingdom, and the United States. More sites and countries will follow.
Conclusion: COMPOSE results are expected to inform about optimal treatment options for patients with well-differentiated aggressive grade 2 and grade 3 SSTR+ GEP-NETs, including for first-line therapy.
Abstract ID 21387
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Endocrine Abstracts
ISSN 1470-3947 (print) | ISSN 1479-6848 (online)
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