Dr Hijoka on Updated Efficacy Data With Everolimus Plus Lanreotide in GEP-NETs

“[As of November 2024,] the median PFS with everolimus plus lanreotide was [29.7] months and was [13.6] months with everolimus [alone]…Even the updated data [show that the] median PFS was significantly prolonged [with everolimus monotherapy]. [These data are] greatly meaningful for the clinical situation.”

Susumu Hijioka, MD, PhD, Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center, Japan, discusses updated efficacy findings with everolimus (Afinitor) plus lanreotide (Somatuline depot) vs everolimus monotherapy in patients with unresectable or recurrent gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in the first-line setting.

Findings from an interim analysis of the phase 3 STARTER-NET trial (jRCT1031200023), which were presented at the 2025 Genitourinary Cancers Symposium, showed that the combination of everolimus and lanreotide significantly prolonged progression-free survival (PFS) vs everolimus alone and was generally well tolerated, Hijioka begins. A preplanned interim analysis was conducted after 50% of patients were enrolled onto the study to evaluate whether patient enrollment should reasonably continue, he notes, adding that the study was terminated early based on findings from this analysis and the recommendation of the JCOG Data and Safety Monitoring Committee.

At the data cutoff of June 2024, the median PFS in the everolimus arm was 11.5 months (95% CI, 9.0-19.8), Hijioka reports. In contrast, the median PFS with the combination was 29.7 months (95% CI, 20.5-not evaluable), resulting in a HR of 0.38 (95% CI, 0.15-0.96; 1-sided P = .00017). The predictive probability of superior efficacy with the combination vs everolimus alone in the final analysis was 98.1%.

As of the November 2024 update, the median PFS was 29.7 months (95% CI, 21.4-38.2) in the combination arm and 13.6 months (95% CI, 9.1-19.4) in the monotherapy arm, with a HR of 0.44 (95% CI, 0.28-0.69; 1-sided P = .00016), Hijioka continues. Even with the updated data, the median PFS was significantly prolonged in the combination arm and therefore clinically meaningful, Hijiokasays. Importantly, the key secondary end point, OS, was comparable between both arms. However, the HR for OS was 0.74 (95% CI, 0.25-2.24), he concludes.