Elicio reports Phase 2 AMPLIFY-7P results; ITT DFS endpoint not met

AMPLIFY-7P was a randomized Phase 2 study of camupepimut versus observation in patients with mutant KRAS-driven pancreatic ductal adenocarcinoma after standard locoregional therapy; 144 patients were enrolled across 24 U.S. clinical sites.

The study did not meet its pre-specified primary DFS endpoint in the intent-to-treat population (HR 0.85).

In the baseline ctDNA-negative subgroup, median DFS was not reached with camupepimut versus 21.2 months with observation (HR 0.51; nominal p=0.0280).

In the baseline ctDNA-positive subgroup, median DFS was 4.3 months with camupepimut versus 1.9 months with observation (HR 0.57; nominal p=0.0489).

Among patients without prior radiation, median DFS was 23.8 months with camupepimut versus 10.4 months with observation (HR 0.59; nominal p=0.0221).

Baseline ctDNA positivity occurred in 20.8% of the camupepimut arm versus 12.5% of the observation arm, and the multivariable adjusted treatment HR was 0.47 (p=0.0086).

Mutant KRAS-specific T-cell responses occurred in 99% of evaluable treated patients; Grade 3 or higher adverse events occurred in 10.4% of the camupepimut arm versus 14.6% of the observation arm, and no adverse events led to study-medication withdrawal.