Elicio Therapeutics has reported that its Phase II AMPLIFY-7P study evaluating ELI-002 7P in patients with adjuvant mKRAS-driven pancreatic ductal adenocarcinoma (PDAC) did not meet its endpoint of disease-free survival (DFS).  

However, the company says landmark analyses during active ELI-002 7P treatment indicated early treatment benefit. Post-hoc landmark analyses showed a consistent ~14% absolute DFS benefit during active treatment at both three and six months, suggesting early clinical activity, with treatment-arm separation persisting through nine months. 

While nodal status, the prespecified stratification factor, was balanced between treatment arms, a higher proportion of patients with the adverse prognostic factor, R1 resection status, were included in the ELI-002 7P arm (19% vs. 10%).  

Post-hoc analyses showed significant DFS improvement in lower residual disease patients. Importantly, this subgroup represented approximately 84% of enrolled patients. Currently, there are no approved therapies following locoregional treatment. 

The study has informed a refined Phase III development strategy focused on a defined, lower residual disease, R0 resected population with additional dosing. The study also demonstrated a strong association between mKRAS-specific immune responses and clinical outcomes. 

“While AMPLIFY-7P did not meet its primary endpoint in the intent-to-treat study population, promising efficacy signals in patients with lower residual disease burden sharpen our path forward,” said Robert Connelly, President and Chief Executive Officer of Elicio. “We identified the patients who benefit most, validated the biology, and demonstrated a favourable safety profile that supports extended dosing in Phase III.  

“In a disease where no approved options exist after surgery, we believe AMPLIFY-7P demonstrates that ELI-002 7P, an mKRAS-targeted immunotherapy, can generate robust immune responses associated with improved clinical outcomes.”