ITM Reports Topline Data from P-III (COMPETE) Trial of ITM-11 to Treat Grade 1 or Grade 2 Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs)
Shots:
- The P-III (COMPETE) trial assessed ITM-11 (7.5 GBq + nephroprotective amino acid, Q3M × max. 4 cycles) vs everolimus (10mg for ~30mos. or until disease progression) in patients (n=309) with inoperable, progressive, SSTR+ gr 1/2 GEP-NETs. The US FDA’s NDA submission is expected in 2025
- The study met its 1EP of improved PFS, while dosimetry data & 2EPs (ORR, OS & quality of life tests), plus subgroup analyses are under evaluation
- Additionally, ITM-11 is being evaluated in P-III (COMPOSE) trial as a 1L /2L therapy to treat patients with gr 2/3 SSTR+ GEP-NET tumors vs SoC CT. It is also in P-I pediatric trial for SSTR+ tumors (KinLET) & IIT P-III trial for lung & thymus NETs (LEVEL)
Ref: Globenewswire | Image: ITM
Related News:- ITM Isotope Technologies Munich and Debiopharm Partner to Develop ITM-91/ITM-94D Theranostic Pair for Solid Tumors
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
