Elicio's ELI-002 7P Phase 2 Misses Primary Endpoint; Refines Phase 3
Elicio Therapeutics announced that its randomized Phase 2 AMPLIFY-7P study for ELI-002 7P in mKRAS-driven pancreatic cancer did not meet its pre-specified primary endpoint of disease-free survival (DFS) in the intent-to-treat population. However, post-hoc analysis identified a stronger DFS hazard ratio (HR 0.65, p=0.048) in the R0, completely resected patient population, which represents 84% of the study participants. This subgroup showed a median DFS of 23.8 months vs. 12.8 months for observation. The company plans a refined Phase 3 development strategy focusing on R0 resected patients with additional dosing, and is evaluating financing and partnering opportunities to support future clinical development, with current cash expected to last into Q4 2026.
Key Highlights
- AMPLIFY-7P study did not meet its primary disease-free survival (DFS) endpoint in the intent-to-treat population.
- Post-hoc analysis showed DFS HR 0.65 (p=0.048) in R0 resected patients (n=121).
- R0 resected patients had median DFS of 23.8 months vs. 12.8 months for observation.
- R0 resected patients represented approximately 84% of the AMPLIFY-7P study population.
- mKRAS-specific T cell responses strongly correlated with improved DFS (HR 0.22, p<0.0001, n=90).
- ELI-002 7P demonstrated a favorable safety profile with no treatment-related discontinuations or deaths.
- Elicio expects current cash and cash equivalents to support planned operations into Q4 2026.
Price Impact
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