- ITM Isotope Technologies Munich SE (ITM) announced positive dosimetry data from its Phase 3 COMPETE trial for **n.c.a. 177Lu-edotreotide (ITM-11)**, a targeted radiotherapeutic agent for patients with Grade 1 or Grade 2 somatostatin receptor (SSTR)-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs).  **[1038277_0eadfb384c9c43968efe29cc433d1dec_0]** 
- The data, presented on **October 8, 2025**, demonstrated that ITM-11 delivered **targeted radiation to tumors** while minimizing exposure to healthy tissue, supporting its favorable efficacy and safety profile.  **[1038277_0eadfb384c9c43968efe29cc433d1dec_0]** 
- Key dosimetry findings showed a significantly higher absorbed dose in tumors (**110.0 ± 90.8 Gy**) compared to normal organs, with kidney and red bone marrow doses remaining well below assumed safety thresholds.  **[1038277_0eadfb384c9c43968efe29cc433d1dec_0]** **[1038277_0eadfb384c9c43968efe29cc433d1dec_1]** 
- The COMPETE trial previously met its primary endpoint in January and March 2025, demonstrating **significantly longer median progression-free survival** for 177Lu-edotreotide compared to everolimus.  **[1038277_0eadfb384c9c43968efe29cc433d1dec_0]** 
- Renal adverse events (Grade ≥1) occurred less frequently with 177Lu-edotreotide (**14.7%**) compared to everolimus (**21.2%**).  **[1038277_0eadfb384c9c43968efe29cc433d1dec_0]** **[1038277_0eadfb384c9c43968efe29cc433d1dec_1]**

INTERNATIONAL ISOTOPES (INIS)