Multicenter phase 1 trial of lymph node-targeted, mKRAS-specific amphiphile vaccine in pancreatic and colorectal cancer

The multicenter phase 1 AMPLIFY-201 trial in the USA evaluated the lymph-node targeted, mKRAS-specific amphiphile off-the-shelf vaccine ELI-002-2P in patients with minimal residual mKRAS disease after standard locoregional treatment for pancreatic (n=20) or colorectal (n=5) cancer. After average follow-up of 19.7 months, T cell responses to mutant KRAS tumor proteins were observed in 68% of patients, associated with improved radiographic relapse-free survival (not reached versus 3.02 months; HR 0.12; p=0.00002) and median overall survival (not reached versus 15.98 months; HR 0.23; p=0.0099).