Elicio Therapeutics Says AMPLIFY-7P Study Did Not Meet Its Pre-specified Primary DFS Endpoint

(RTTNews) - Biotechnology company Elicio Therapeutics, Inc. (ELTX) announced Monday that the Phase 2 AMPLIFY-7P study evaluating ELI-002 7P in patients with adjuvant mKRAS-driven pancreatic ductal adenocarcinoma (PDAC) did not meet the pre-specified primary endpoint of disease-free survival (DFS) in the intent-to-treat population following the completion of standard locoregional therapy.

However, landmark analyses during active ELI-002 7P treatment indicated early treatment benefit.

The post-hoc landmark analyses showed a consistent about 14% absolute DFS benefit during active treatment at both 3 and 6 months, suggesting early clinical activity, with treatment-arm separation persisting through 9 months.