Elicio Therapeutics Phase 2 Trial Misses Primary DFS Endpoint
Elicio Therapeutics said its Phase 2 AMPLIFY-7P study of camupepimut (ELI-002 7P) did not meet the ITT primary DFS endpoint (HR 0.85). The company cited a baseline ctDNA imbalance and plans to discuss a refined Phase 3 strategy with the FDA.
Elicio Therapeutics said its randomized Phase 2 AMPLIFY-7P trial of camupepimut (ELI-002 7P) did not meet the primary disease-free survival (DFS) endpoint in the intention-to-treat (ITT) population, reporting a hazard ratio (HR) of 0.85. The company cited an imbalance in baseline circulating tumor DNA (ctDNA) and plans to discuss a refined Phase 3 strategy with the FDA.