Onco-Summaries: Daily Oncology Updates at a Glance
- Oncofocus Team
- 1 day ago
- 1 min read
07/07/2026
ITM‑11 significantly outperforms everolimus in advanced GEP‑NETs with superior efficacy and safety (Ref)
ITM announced that primary results from its Phase 3 COMPETE trial were published in The Lancet, showing that investigational ¹⁷⁷Lu-edotreotide (ITM-11; SSTR2-targeted peptide receptor radionuclide therapy) significantly improved progression-free survival and response rates vs everolimus in Grade 1/2, somatostatin receptor (SSTR)-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs) patients.
The trial enrolled 309 patients across 49 sites and met its primary endpoint with a favorable safety profile for ITM-11
Median PFS: 23.9 mos (ITM-11) vs 14.1 mos (everolimus); HR 0.67, p=0.022
Objective response rate: 22% vs 4% (central review), p<0.0001
Grade 3/4 TRAEs: 18% vs 40%
Common side effects for ITM-11: diarrhea and nausea (36% each), asthenia (33%)
57.6% of patients had pancreatic NETs, an area with limited treatment options
Upcoming milestones:
ITM-11 is currently under US FDA regulatory review
Long-term follow-up: patients will be monitored up to 5 years for survival/safety data
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