ITM Reports Positive Phase 3 Data for Radiopharmaceutical ITM-11 in Neuroendocrine Tumors, Challenging Novartis’ Lutathera
ITM reported positive topline results from the Phase 3 COMPETE trial of ITM-11 (177Lu-edotreotide) in gastroenteropancreatic neuroendocrine tumors (GEP-NETs).
ITM-11 significantly improved progression-free survival (PFS) compared to everolimus:
Median PFS:
23.9 months for ITM-11 vs 14.1 months for everolimus
Statistically significant improvement (p=0.022)
Overall survival data showed a favorable trend for ITM-11 but was not statistically significant:
Median OS:
63.4 months for ITM-11 vs 58.7 months for everolimus
ITM-11 was well-tolerated with fewer treatment-emergent adverse events than everolimus (82.5% vs 97%).
ITM plans to submit a New Drug Application to the FDA in 2025.
If approved, ITM-11 would compete directly with Novartis' Lutathera, which is already approved for GEP-NETs.
This is the first radiopharmaceutical to outperform a targeted molecular therapy in a head-to-head Phase 3 trial for GEP-NETs.
The results validate ITM's approach of developing radiopharmaceuticals to compete with standard targeted therapies in oncology.