Elicio Therapeutics announced on June 15 that its share price dropped by half in premarket trading after a mid-stage study of its pancreatic cancer candidate failed to meet the primary endpoint of disease-free survival. Despite this setback, the company plans to move forward with a Phase 3 trial.
Shares of Elicio fell 73% to $4 each as markets opened Monday morning. The company, based in Boston, said it remains optimistic about the future of its investigational immunotherapy ELI-002 7P. H.C. Wainright wrote in a note to investors that results from the Phase 2 AMPLIFY-7P trial “are more nuanced than they initially appear.”
The AMPLIFY-7P study evaluated ELI-002 7P in patients with adjuvant mutant KRAS-driven pancreatic cancer following locoregional therapy, compared to a standard care observational cohort. According to Elicio’s press release, the missed endpoint was attributed to a higher proportion of R1-resected patients—those with tumor present at or within one millimeter of the surgical margin—in the treatment arm (19%) versus the observational arm (10%). H.C. Wainright also noted this difference and said, “This distinction is important because R1 resection is generally associated with earlier disease recurrence, a greater risk of local recurrence, and poorer overall survival compared with R0 resection.”
Elicio reported positive signals from posthoc analyses: an approximately 14% absolute disease-free survival benefit during active treatment at three, six and nine months. Further analysis showed stronger hazard ratios for disease-free survival among R0-resected patients—the group where tissue surrounding the surgical site is free of cancer cells—with absolute recurrence rates at eighteen months being 9.5% lower in those receiving treatment versus observation; median disease-free survival for these patients was reported as 23.8 months versus 12.8 months.
The company said it will prioritize R0-resected patients for its Phase 3 development strategy and highlighted that “DFS benefit in R0-resected patients supports Phase 3 advancement despite [the intent-to-treat] DFS miss,” according to H.C. Wainright.
ELI-002 7P demonstrated what Elicio described as a favorable safety profile: no treatment-related discontinuations or deaths were observed, and there were fewer adverse events among treated participants compared to those under observation.
