Elicio pancreatic cancer vaccine misses Phase II primary endpoint but shows post-hoc signal in resected patients
Elicio Therapeutics' Phase II AMPLIFY-7P trial of its pancreatic cancer vaccine ELI-002 7P failed to meet its primary endpoint of disease-free survival (DFS) in the intent-to-treat population of patients with resected, stage I–III mKRAS-driven pancreatic ductal adenocarcinoma.
Shares of Elicio plummeted by roughly 47–72% following the announcement, reflecting the significance of the miss and the loss of a straightforward path to Phase III approval.
Despite the overall miss, a post-hoc analysis of the R0 completely resected subgroup (about 84% of enrolled patients) showed a statistically significant DFS improvement (HR 0.65, p=0.048), with median DFS of 23.8 months versus 12.8 months for observation, giving the company a signal to pursue a refined Phase III strategy focused on this subgroup.
Sources:
Elicio Pancreatic Cancer Vaccine Misses Primary Goal - AllSci
Elicio Therapeutics stock tumbles after trial misses endpoint
Elicio Therapeutics Faces Major Setback in Cancer Drug Trial
Elicio Therapeutics Shares Fall After Pancreatic Cancel Trial Misses Primary Endpoint
Off-the-shelf cancer vaccine elicits strong immune ...
Elicio shares slide after pancreatic cancer vaccine falls short in mid ...
Elicio signals delay in mid-stage cancer vaccine study; shares slump
Elicio completes phase 2 enrollment for cancer vaccine
Elicio Therapeutics Announces Completion of Phase 2 ...
Elicio Therapeutics Announces FDA Clearance of IND application ...
Very significant valuation arbitrage
Why Is Cancer Vaccine Developer Elicio Therapeutics Stock Trading Lower On Friday?
Elicio Therapeutics' investigational cancer immunotherapy failed to ...