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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