The radiopharmaceutical Lutetium-177 (Lu-177) edotreotide delivers clinically meaningful and durable quality-of-life improvements in patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs), according to research presented at the American Society of Clinical Oncology (ASCO) meeting in Chicago.
A subset analysis of the phase III COMPETE trial presented by study investigator Jaume Capdevila, MD, PhD, of Vall d'Hebron University Hospital in Barcelona, Spain, found that on average, patients receiving Lu-177 edotreotide were more likely to report a quantifiable improvement in quality of life, as well as a longer time to deterioration.
“For patients with GEP-NETs, treatment decisions are not only about preventing disease progression, but also about preserving daily functioning and quality of life,” said Capdevila in a statement from radiopharmaceutical firm ITM, which has developed the drug it calls ITM-11. “Together with the previously reported efficacy results, these findings add important patient-centered evidence to inform treatment discussions.”
In the COMPETE trial, Lu-177 edotreotide was compared to the standard-of-care treatment of everolimus in patients with inoperable, progressive Grade 1 or Grade 2 GEP-NETs. The study found that the radiopharmaceutical met its primary endpoint of improving progression-free survival in these patients.
In this secondary analysis of COMPETE, the researchers assessed health-related quality of life data in patients both before and after receiving Lu-177 edotreotide or everolimus. Of the 309 patients included in this analysis, 207 had received Lu-177 edotreotide and 102 were given everolimus.
Patients completed two questionnaires to assess overall health as well as physical and social functioning. These surveys -- QLC-C30 and QLQ-GI.NET 21 -- at baseline, monthly during the first year after treatment, and then every three months afterwards.
The researchers found that patients who received Lu-177 edotreotide had an average quality of life score that had an average score change of +0.9. With an average score change of –9.9, patients who were treated with everolimus experienced a meaningful decline in quality of life, however.
What’s more, patients who were given Lu-177 edotreotide reported a median time of 10.3 months before quality of life began to decline, compared to 2.3 months for everolimus. In other findings, 45.3% of patients on L7-177 edotreotide reported a meaningful improvement in quality of life, compared with 30.4% of those receiving everolimus. For those who improved after treatment, the median duration of improvement was 22 months with Lu-177 edotreotide and 10.2 months for everolimus.
In their press release, ITM said the data further strengthen ITM-11's clinical profile ahead of the U.S. Food and Drug Administration’s upcoming decision on the Prescription Drug User Fee Act (PDUFA) date set for August 28. Dosimetry data was also presented for ITM-11 this week at the annual meeting of the Society of Nuclear Medicine and Molecular Imaging (SNMMI) in Los Angeles.
