Elicio Trial Misses Disease-Free Survival Goal Despite Later Improvement in R0 Patients
Key Facts
Elicio Therapeutics said on June 15, 2026, that its randomized Phase 2 AMPLIFY-7P trial did not meet the prespecified primary endpoint of disease-free survival in the intention-to-treat population. The study tested the ELI-002 7P vaccine against surveillance in patients with KRAS-mutated pancreatic ductal adenocarcinoma after local therapy. The trial included 144 patients at 24 U.S. clinical sites. The failure represents the study’s primary result, while the company presented subsequent analyses of participant subgroups. CEO Robert Conley said efficacy signals among patients with lower residual disease burden "refine our path forward."
In a subsequent analysis of 121 patients who underwent complete R0 resection, median disease-free survival was 23.8 months among those who received the vaccine, compared with 12.8 months in the surveillance group. The company estimated a hazard ratio of 0.65, with a p-value of 0.048. However, these results relate to a subsequent subgroup analysis and do not change the primary endpoint result in the intention-to-treat population. R0 patients accounted for about 84% of participants. The company said incomplete R1 resection is associated with a poor prognosis for recurrence and was present in 19% of the vaccine arm versus 10% of the surveillance arm.
Other exploratory analyses showed differences in disease-free survival rates at earlier time points. At month three, the rate was 90.3% with ELI-002 7P versus 76.6% with surveillance, with a p-value of 0.022. At month six, the vaccine group recorded 75.7% versus 61.7% for surveillance, but the p-value was 0.056. In an immune analysis of 90 evaluable patients, an mKRAS-specific T-cell response was associated with improved disease-free survival, with a hazard ratio of 0.22 and a p-value below 0.0001. These immune findings and time-point analyses accompany the unmet primary result and do not replace it.
On safety, Elicio said the treatment was not associated with any discontinuations or treatment-related deaths. It added that the adverse-event rate was proportionally lower in the vaccine arm than in the surveillance arm. The company statement did not give a specific adverse-event rate in these results, but said there were no treatment-related discontinuations or deaths. The company is using the data in its review of the next trial’s design, with a proposed focus on patients who underwent R0 resection after standard local therapy. The concept includes additional doses and a primary endpoint of disease-free survival.
The company said the start of a registrational Phase 3 study remains subject to funding availability. Elicio shares had fallen about 73% in early trading on June 15, the date the trial result was announced. In a later disclosure, the company said it completed a $15 million direct financing in July 2026, and that available cash would support operations through the first quarter of 2027. The disclosure does not specify that Phase 3 funding has been secured, while the company has kept its plan contingent on funding. It also expected to begin a Phase 1 trial in the fourth quarter of 2026 combining ELI-002 7P with a small-molecule RAS inhibitor, with or without a PD-1 inhibitor, in patients with metastatic pancreatic cancer.
Elicio had scheduled the presentation of AMPLIFY-7P analyses at the European Society for Medical Oncology (ESMO) Congress on October 23, 2026, in Madrid, during the congress running from October 23 to 27. The presentation date followed the announcement of the Phase 2 results in June and was not a new announcement of the trial’s failure. The company’s announced plan is to refine its Phase 3 strategy in light of results in the R0 group. The company tied implementation of the next study to funding availability, while its disclosure indicated expected cash runway through the first quarter of 2027. The parallel Phase 1 trial is scheduled to begin in the fourth quarter of 2026, according to the company’s projection.