Elicio Therapeutics reports Phase 2 pancreatic cancer vaccine misses primary disease‑free survival endpoint
Elicio Therapeutics (ELTX) announced that its Phase 2 AMPLIFY‑7P trial of the KRAS‑targeted vaccine camupepimut did not achieve the pre‑specified intent‑to‑treat disease‑free survival (DFS) primary endpoint, with a hazard ratio of 0.85. The company said the result was affected by an imbalance in baseline ctDNA positivity between arms. Subgroup analyses showed more favorable DFS in ctDNA‑negative patients (HR 0.51) and in ctDNA‑positive patients (HR 0.57). Elicio plans to meet with the FDA to discuss a revised Phase 3 design.
Why it matters
The missed primary endpoint signals a setback for the vaccine’s development timeline and may pressure the stock until a Phase 3 strategy is clarified (the company said it will discuss findings with the FDA). No analyst commentary was provided in the materials.
Key facts
- 1The trial enrolled 144 patients across 24 U.S. sites. investing.com
- 2In the intent‑to‑treat population the hazard ratio for DFS was 0.85, missing the primary endpoint. investing.com
- 3Baseline ctDNA positivity was 20.8% in the camupepimut arm versus 12.5% in the observation arm. investing.com
- 4In ctDNA‑negative patients median DFS was not reached with camupepimut versus 21.2 months with observation (HR 0.51). stocktitan.net
- 5In ctDNA‑positive patients median DFS was 4.3 months with camupepimut versus 1.9 months with observation (HR 0.57). stocktitan.net
- 6Mutant KRAS‑specific T‑cell responses were observed in 99% of evaluable treated patients. stocktitan.net
Summary written by AlphAI AI Desk from 3 of 3 sources. Not investment advice. Figures are as stated by the linked sources.