Key insights
- Elicio Therapeutics' Phase 2 trial for camupepimut in pancreatic cancer missed its primary disease-free survival endpoint in the overall patient population. However, subgroup analyses showed favorable trends, particularly in ctDNA-negative patients and those without prior radiation. The company plans to discuss these findings with the FDA regarding a potential Phase 3 study, considering patient stratification.
Elicio Therapeutics (Nasdaq: ELTX) reported results from its randomized Phase 2 AMPLIFY-7P study of camupepimut (ELI-002 7P) at the European Society for Medical Oncology Congress 2026 in Madrid, with simultaneous publication in Nature Medicine.
The study, which enrolled 144 patients across 24 U.S. clinical sites, did not meet its pre-specified primary disease-free survival (DFS) endpoint in the intent-to-treat population, recording a hazard ratio of 0.85. The company noted a baseline imbalance in circulating tumor DNA (ctDNA) positivity between arms, with 20.8% of camupepimut patients testing positive at baseline versus 12.5% in the observation arm. Baseline ctDNA positivity was associated with a median DFS of 4.2 months compared to 24.0 months for ctDNA-negative patients across both arms.
Pre-specified subgroup analyses showed favorable treatment-effect trends. In 93 ctDNA-negative patients, median DFS was not reached in the camupepimut arm versus 21.2 months under observation (HR 0.51; p=0.0280). In the smaller ctDNA-positive subgroup of 26 patients, median DFS was 4.3 months versus 1.9 months (HR 0.57; p=0.0489). Among 106 patients without prior radiation, median DFS was 23.8 months with camupepimut versus 10.4 months with observation (HR 0.59; p=0.0221).
A multivariable model adjusting for baseline factors estimated camupepimut was associated with a 53% lower risk of recurrence or death (adjusted HR 0.47; p=0.0086).
Camupepimut induced mutant KRAS-specific T-cell responses in 99% of evaluable treated patients, with responses persisting at least 46 weeks in 95.5% of evaluable patients. Grade 3 or higher adverse events occurred in 10.4% of camupepimut patients versus 14.6% under observation, with no withdrawals due to adverse events.
Elicio said it plans to discuss the AMPLIFY-7P findings with the U.S. Food and Drug Administration to inform a potential Phase 3 study in adjuvant pancreatic cancer, with considerations including patient stratification based on ctDNA status, treatment duration, and combination strategies.
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