
ITM Reports Topline Data from P-III (COMPETE) Trial of ITM-11 at the ENETS 2025 Conference
Shots:
- The P-III (COMPETE) trial assessed ITM-11 (n=207) vs everolimus (n=102) in pts (N=309) with inoperable, progressive, SSTR+ Grade 1 or 2 Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs). The US FDA’s NDA filing is expected in 2025
- The study met its 1EP of improved PFS with mPFS of 23.9 vs 14.1mos., while dosimetry data, ORR, QoL tests, & subgroup analyses are under evaluation & will be reported at future meetings
- As of Jan 21, 2025, the trial showed a favorable trend with mOS (63.4 vs. 58.7mos.). Pts switched to alternate therapy in case of progression which may have impacted OS data, although it will continue to mature
Ref: Globenewswire | Image: ITM
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