Elicio Therapeutics Reports Results from Phase 2 AMPLIFY-7P Study and Outlines Refined Phase 3 Development Strategy for ELI-002 7P in Adjuvant Pancreatic Cancer
AMPLIFY-7P did not meet the pre-specified primary endpoint of disease-free survival ("DFS") in the intent-to-treat population.Randomization balanced most prognostic factors between arms. However, the ELI-002 7P arm had a higher proportion of R1 resected (higher residual disease, tumor present at or within 1 mm of surgical margin) patients compared with the observation arm (ELI-002 7P 19% vs. observation 10%), a known adverse prognostic factor for recurrence. R1 patients have increased relapse-risk, implying that this imbalance meaningfully and negatively impacted the ELI-002 arm.Post-hoc analysis identified a stronger DFS hazard ratio in the R0, completely resected population (post-hoc HR 0
