Elicio Therapeutics AMPLIFY-7P Phase 2 (June 15): ELI-002 7P KRAS Peptide Vaccine Misses Primary DFS Endpoint in Adjuvant Pancreatic Cancer, But Shows 14% Absolute DFS Benefit During Active Treatment — Phase 3 Strategy Refined
Elicio Therapeutics announced June 15, 2026 that the randomized Phase 2 AMPLIFY-7P study of ELI-002 7P (a 7-peptide formulation targeting the seven most common KRAS mutations, combined with the ELI-004 amphiphile-modified CpG oligonucleotide adjuvant) in patients with adjuvant mKRAS-driven pancreatic ductal adenocarcinoma did not meet its pre-specified primary disease-free survival (DFS) endpoint in the intent-to-treat population. Post-hoc landmark analyses, however, showed a consistent 14% absolute DFS benefit during active treatment at both 3 and 6 months, with treatment-arm separation persisting through 9 months — suggesting early clinical activity that waned over time. Elicio is refining its Phase 3 development strategy based on the data. The 7P formulation extends the 2-peptide ELI-002 2P AMPLIFY-201 program covered in this site's April 29 digest (Nature Medicine publication, durable T-cell responses, median RFS not reached vs 3.02 months in non-responders). KRAS mutations drive roughly 90% of pancreatic cancers and 50% of colorectal cancers, making the KRAS peptide vaccine class one of the highest-impact targets in solid-tumor oncology.