Elicio Plans Phase 3 in R0 Pancreatic Cancer Following 23.8 vs 12.8 Month DFS Gain
ELTX•Elicio’s Phase 2 AMPLIFY-7P trial of ELI-002 7P did not meet the primary DFS endpoint in the intent-to-treat population, but post-hoc analysis in R0 resected patients showed HR 0.65 (p=0.048), median DFS 23.8 vs 12.8 months. Strong mKRAS-specific T-cell responses (HR 0.22, p<0.0001) inform a Phase 3 R0-focused strategy.
1. Phase 2 Trial Results
The AMPLIFY-7P study evaluated ELI-002 7P versus observation in 144 resected pancreatic cancer patients and did not meet its pre-specified primary disease-free survival endpoint in the intent-to-treat population. A higher proportion of R1 resected patients in the treatment arm (19% vs. 10%) likely impacted outcomes.
2. R0 Subgroup Efficacy
Post-hoc analysis in the R0 resected subgroup (84% of subjects) showed a DFS hazard ratio of 0.65 (p=0.048), with median DFS of 23.8 versus 12.8 months and a 9.5% lower absolute recurrence rate at 18 months.
3. Immune Correlates of Response
Mutant KRAS-specific T-cell responses strongly correlated with improved DFS, yielding a hazard ratio of 0.22 (p<0.0001) in 90 evaluable patients, demonstrating the biological activity of ELI-002 7P.
4. Refined Phase 3 Strategy
Insights from AMPLIFY-7P inform a Phase 3 trial focused on completely resected R0 patients with additional dosing to enhance durability. Elicio is exploring strategic financing and partnerships to support this development and potential combination therapies.
