Breakthrough Cancer Vaccine Shows Promising Results in Pancreatic and Colorectal Cancers

A phase I clinical trial has demonstrated that an off-the-shelf cancer vaccine targeting KRAS mutations significantly prolonged survival in patients with pancreatic and colorectal cancers. The vaccine, ELI-002 2P, induced robust T-cell responses and showed impressive outcomes in patients with resected cancers and minimal residual disease (MRD).
Results from the AMPLIFY-201 trial, published in Nature Medicine, revealed that among 25 patients with MRD after standard treatment, the median relapse-free survival was 16.3 months, and median overall survival was 28.9 months—both exceeding historical norms. In the 20-patient pancreatic cancer subset, median relapse-free survival was 15.3 months, and overall survival was 28.9 months.
The study highlighted a strong correlation between T-cell responses specific to KRAS mutations and survival outcomes. Patients with the strongest T-cell responses lived longer and remained recurrence-free longer than those with weaker responses. Of the 25 patients, 21 developed KRAS mutation-specific T-cell responses, with 59% showing both CD4+ and CD8+ activity.
The vaccine’s safety profile was favorable, with no dose-limiting toxicities or severe adverse events. The trial also demonstrated that the vaccine’s amphiphile platform effectively delivers peptides to lymph nodes, enhancing immune responses.
Pancreatic cancer, which often recurs despite treatment, was a key focus of the study. KRAS mutations occur in about 90% of pancreatic cancer cases, making the vaccine a potential game-changer for this hard-to-treat disease.
A randomized phase II trial targeting seven KRAS peptides is currently ongoing, with the goal of expanding the vaccine’s applicability to a broader patient population. These findings mark a significant step forward in the fight against cancers driven by KRAS mutations.

Published: 8/13/2025