News
Article
Study: Radiotherapeutic Agent for GEP-NETs Demonstrates Positive Results
Author(s):
Key Takeaways
- Lu-edotreotide significantly improved progression-free survival in GEP-NETs compared to everolimus, marking a first for radiopharmaceutical therapy in a phase 3 trial.
- GEP-NETs are rare tumors that can be asymptomatic, often leading to delayed diagnosis at the metastatic stage.
Lu-edotreotide (ITM-11; ITM) met its primary endpoint of prolonging progression-free survival (PFS).
New study findings demonstrated positive topline results from the phase 3 COMPETE (NCT03049189) trial that assessed lu-edotreotide (ITM-11; ITM), a proprietary, synthetic, targeted radiotherapeutic agent for the treatment of inoperable, progressive grade 1 or grade 2 gastroenteropancreatic neuroendocrine tumors (GEP-NETs).1
The results showed that lu-edotreotide met its primary endpoint of prolonging progression-free survival (PFS) in comparison to everolimus (Afinitor; Novartis), a targeted molecular therapy.1
“With COMPETE, this marks the first time that a targeted radiopharmaceutical therapy has demonstrated improved progression-free survival compared to a targeted molecular therapy, everolimus, in patients with Grade 1 and Grade 2 gastroenteropancreatic neuroendocrine tumors in a Phase 3 clinical trial,” Jaume Capdevila, MD, PhD, study investigator and senior medical oncologist at Vall d'Hebron University Hospital in Barcelona, said in a news release.1
GEP-NETs are rare tumors that often form in the pancreas, stomach, small intestine, colon, rectum, and appendix, developing in cells that secrete hormones. In some cases, the tumors produce extra hormones and additional substances that present signs and symptoms of the disease, according to research from the National Cancer Institute.2
Symptoms of GEP-NET depend on the location of the tumor and if the tumor is nonfunctional or functional. Common symptoms include rectal bleeding and/or blood in the stool, a change in size, shape or color of the stool, discomfort or urge to have a bowel movement, bloating or a feeling of fullness, unexplained weight loss, and pain in the abdomen or lower back.3 However, some individuals with GEP-NETs may be asymptomatic, resulting in a delayed diagnosis in the metastatic stage.4
As a radiolabeled peptide conjugate, lu-edotreotide could offer further treatment for GEP-NETs with its role to deliver beta radiation to the somatostatin receptor (SSTR)-positive tumor cells, and spare healthy organs and tissues. The drug is administered intravenously and consists of a non-carrier-added lutetium-177 (Pluvicto; Novartis), a therapeutic β-emitting radioisotope, along with edotreotide, a synthetic SSTR agonist, according to study authors.1
The prospective, randomized, controlled, open-label phase 3 COMPETE trial included 309 individuals with grade 1 or grade 2 inoperable, progressive, somatostatin receptor-positive neuroendocrine tumors of gastroenteric or pancreatic origin. The individuals were randomly assigned 2:1 to receive 7.5 GBp of lu-edotreotide with a nephroprotective amino acid solution every 3 months for 4 cycles; or 10 mg of everolimus daily for 30 months, or until disease progression.1
In addition to meeting its primary endpoint of PFS, lu-edotreotide demonstrated well tolerability with favorable safety results. However, secondary endpoints of overall survival and quality of life assessments and ongoing.1
“The patients included represent a real-life scenario, and the COMPETE study evaluates the important question of which therapy might be used first to provide greater benefit to patients,” said Capdevila in a news release.1
The study authors noted that an additional prospective, randomized, controlled, open-label phase 3 COMPOSE trial is underway, assessing the safety, efficacy, and patient-reported outcomes of lu-edotreotide as a first- or second-line treatment, compared with physician’s choice standard of care chemotherapy.1
