[177Lu]Lu-edotreotide (SSTR2-targeted PRRT) beats everolimus on PFS in progressive GEP-NETs (COMPETE)

[177Lu]Lu-edotreotide is a somatostatin receptor (SSTR; high affinity for SSTR2)–targeted peptide receptor radionuclide therapy (PRRT; [177LuDOTA]-TOC) compared head-to-head with everolimus (oral mTOR inhibitor) in the Phase 3, multicentre, open-label COMPETE trial (NCT03049189) in unresectable/metastatic, progressive, SSTR-positive grade 1–2 GEP-NETs (n=309; 2:1 randomization). At 30 months by blinded independent central review, median PFS was 23.9 months with [177Lu]Lu-edotreotide vs 14.1 months with everolimus (HR 0.67, p=0.022); this lands above the ~11-month mPFS benchmark everolimus achieved vs placebo in prior Phase 3 NET trials (RADIANT-3 pancreatic NET and RADIANT-4 GI/lung NET). Treatment-related Grade 3–4 AEs were lower with PRRT (18% vs 40%), and TRAEs were less frequent overall (82% vs 97%), with no treatment-related deaths.