177Lu-edotreotide Improves HRQOL vs Everolimus in GEP-NETs

Treatment with ¹⁷⁷Lu-edotreotide conferred better health-related quality of life (HRQOL) outcomes vs everolimus (Afinitor) as a treatment for patients with well-differentiated, grade 1/2, unresectable gastroenteropancreatic neuroendocrine tumors (GEP-NETs), for which the latter is a standard-of-care therapy for, according to a secondary analysis of the phase 3 COMPETE study (NCT03049189) presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting.¹

Specifically, among patients treated with ¹⁷⁷Lu-edotreotide (n = 207) vs everolimus (n = 102), the questionnaire completion rates were high for HRQOL, occurring in at least 85% of each arm. The global health status and QOL scores were stable with ¹⁷⁷Lu-edotreotide, with a least-squares mean change from baseline of 0.9 (95% CI, –2.7 to 4.4), and decreased with everolimus, with a value of –9.9 (95% CI, –13.9 to –6.0). Moreover, the worsening of function and symptoms was less pronounced in the ¹⁷⁷Lu-edotreotide arm than in the everolimus arm per repeated-measures analyses of EORTC QLQ-C30 functional and symptom domains.

A higher proportion of those assigned to receive ¹⁷⁷Lu-edotreotide experienced a clinically meaningful benefit in global health status and QOL scores—a greater than 10-point difference—vs those treated in the everolimus arm; the rates were 43.5% vs 30.4%, respectively. Finally, the median duration of improvement in global health status and QOL score was higher in the ¹⁷⁷Lu-edotreotide arm at 22.0 months (95% CI, 10.1-not evaluable [NE]) vs 10.2 months (95% CI, 3.3-NE) with everolimus; the median time to deterioration was 10.25 months (95% CI, 7.40-15.90) and 2.27 months (95% CI, 2.00-3.25), respectively (HR, 0.39; 95% CI, 0.29-0.53).

The median time to deterioration in physical functioning was 18.30 months (95% CI, 10.61-NE) with ¹⁷⁷Lu-edotreotide vs 3.78 months (95% CI, 3.78-5.06) with everolimus (HR, 0.44; 95% CI, 0.32-0.60; P <.0001). For time to deterioration in social functioning, the median values were 8.12 months (95% CI, 4.90-15.05) vs 2.35 (95% CI, 2.04-2.96) in each respective arm (HR, 0.43; 95% CI, 0.32-0.58; P <.0001). For median time to HRQOL deterioration for insomnia, the median value was 15.41 months (95% CI, 8.64-NE) with ¹⁷⁷Lu-edotreotide vs 4.21 months (95% CI, 2.76-7.13) with everolimus (HR, 0.46; 95% CI, 0.46-0.62; P <.0001).

“¹⁷⁷Lu-edotreotide represents a valuable treatment option for patients with GEP-NETs, demonstrating not only superior efficacy, but also improved HRQOL outcomes compared with everolimus,” Jaume Capdevila, MD, PhD, medical oncologist in the Gastrointestinal and Endocrine Cancer Unit at Vall d’Hebron Hospital and the Teknon Cancer Institute in Barcelona, Spain, wrote in the presentation with study coinvestigators.¹ “A numerically higher proportion of patients treated with ¹⁷⁷Lu-edotreotide showed HRQOL improvements (i.e., global health status/QOL) compared with those treated with everolimus. Median time to HRQOL deterioration was longer with ¹⁷⁷Lu-edotreotide than with everolimus.”

Citing the results of an efficacy analysis of the COMPETE trial, demonstrating that ¹⁷⁷Lu-edotreotide produced superior efficacy and safety outcomes vs everolimus, the investigators conducted this exploratory secondary analysis to review patient HRQOL during and following treatment with each agent.

Patients completed the EORTC QLQ-C30 questionnaires, specifically the EORTC QLQ-QLQ-gastrointestinal neuroendocrine tumors (GI.NET) assessment. Using the repeated-measures analysis, between-group comparisons utilized treatment and randomization stratification factors, baseline values, and treatment-by-visit interactions to conduct the statistical analysis.

The HRQOL end points included mean change from baseline; the proportion of patients with clinically meaningful improvement in, deterioration of, or stability of HRQOL scores; and time to deterioration.

The researchers noted that assessing the real-world effectiveness of ¹⁷⁷Lu-edotreotide as well as patient preferences were future directions for research to help personalize treatment for this GEP-NET population.

The FDA previously accepted a new drug applicationfor ¹⁷⁷Lu-edotreotide as a treatment for patients with GEP-NETs in November 2025.² A Prescription Drug User Fee Act goal date of August 28, 2026, was set by the agency for this indication.

References

1. Capdevila J, Jann H, Verberne HJ, et al. Quality of life in patients with gastroenteropancreatic neuroendocrine tumors receiving 177Lu-edotreotide or everolimus: results from the COMPETE study. J Clin Oncol. 2026;44(suppl 16):4171. doi:10.1200/JCO.2026.44.16_suppl.4171
2. ITM announces FDA acceptance of new drug application (NDA) and PDUFA date for n.c.a. 177Lu-edotreotide (ITM-11) in gastroenteropancreatic neuroendocrine tumors (GEP-NETs). News release. ITM Isotope Technologies Munich SE. November 13, 2025. Accessed May 30, 2026. https://tinyurl.com/2zvjxy6s