Elicio Therapeutics has reported that its Phase 2 Amplify-7P trial of ELI-002 7P in resected pancreatic cancer failed to meet its primary endpoint, although post-hoc analyses identified a subgroup of patients who appeared to derive greater benefit and will form the focus of a planned Phase 3 programme.

The randomised study evaluated ELI-002 7P in patients with mutant KRAS-driven pancreatic ductal adenocarcinoma following surgery and standard locoregional treatment. The primary endpoint was disease-free survival in the intent-to-treat population.

While the trial did not achieve that endpoint, Elicio said patients who underwent complete tumour resection (R0) experienced longer median disease-free survival in exploratory analyses, with a post-hoc hazard ratio of 0.65 and median disease-free survival of 23.8 months compared with 12.8 months in the observation arm.

Robert Connelly, chief executive officer, said: “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.”

The company attributed part of the overall result to an imbalance between treatment groups, noting that 19% of patients receiving ELI-002 7P had R1 resections compared with 10% in the observation arm. R1 resection status is associated with a higher risk of disease recurrence.

The Phase 2 study enrolled 144 patients with Stage 1 to Stage 3 mutant KRAS-driven pancreatic ductal adenocarcinoma across 24 US sites following surgery and standard locoregional therapy.

According to the company, approximately 84% of enrolled participants had R0 resections, representing the population it now intends to target in Phase 3.

The study also found a strong association between mutant KRAS-specific T-cell responses and improved disease-free survival. Patients with the highest immune responses experienced better outcomes than those with weaker responses, supporting the proposed mechanism of action for ELI-002 7P.

Christopher Haqq, head of research and development and chief medical officer, said: “The AMPLIFY-7P trial generated important clinical and biological insights that have sharpened our development strategy and strengthened our conviction in ELI-002 7P.”

Safety findings were favourable, with no treatment-related discontinuations or treatment-related deaths reported during the study. Elicio also said adverse events occurred less frequently in the treatment arm than with standard observation.

Based on the findings, the company plans to pursue a registrational Phase 3 trial focused on patients who have undergone complete R0 resection after standard therapy. The proposed study would also evaluate an extended dosing schedule intended to improve the durability of anti-tumour immune responses.

ELI-002 7P is an immunotherapy designed to stimulate immune responses against cancers driven by mutant KRAS, one of the most common oncogenic mutations in pancreatic cancer. There are currently no approved therapies specifically indicated for patients following surgery and standard locoregional treatment in this setting.

Although the primary endpoint miss represents a setback, the subgroup findings and biomarker data have provided Elicio with a more targeted development strategy as it seeks financing and regulatory discussions for Phase 3 development.