Elicio Therapeutics’ investigational cancer immunotherapy failed to meet the primary endpoint of disease-free survival in a Phase 2 trial—a result the company attributed mostly to a disproportionate number of patients with higher residual disease.
Elicio Therapeutics’ share price halved in premarket trading Monday after a mid-stage study of its pancreatic cancer candidate failed to meet the primary endpoint of disease-free survival. While this may foil the recent winning streak in the space, the failure hasn’t burst Elicio’s bubble, as the biotech plans to forge ahead to Phase 3.
Shares of Elicio fell 73% to $4 apiece as the markets opened Monday morning.
The Boston-based company may have good reason to be optimistic, as H.C. Wainright wrote in a Monday morning note to investors that the results of the Phase 2 AMPLIFY-7P trial “are more nuanced than they initially appear.”
The study evaluated the investigational cancer immunotherapy ELI-002 7P in patients with adjuvant mutant KRAS-driven pancreatic cancer following locoregional therapy compared to a standard of care observational cohort.
Elicio in a Monday press release attributed the endpoint miss to the higher proportion of so-called R1-resected patients—those with a tumor present at or within 1 mm of the surgical margin—in the treatment arm compared with the observational arm of the trial; 19% of patients in the ELI-002 7P arm met this description vs. 10% in the observational arm.
H.C. Wainright also noted this anomaly.
“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,” the analysts wrote. R0 resection describes cases where the tissue surrounding the surgical site is completely free of cancer cells.
Elicio noted another positive signal in the posthoc analyses: an approximately 14% absolute disease-free survival (DFS) benefit during active treatment at three, six and nine months, pointing to early clinical activity.”
The posthoc analyses also showed a stronger DFS hazard ratio in R0 patients. At 18 months, absolute recurrence rates in these patients, who represented around 84% of the overall study population, were 9.5% lower in the treatment arm, Elicio reported. The median DFS for R0 patients in the trial was 23.8 months vs. 12.8 months in the observation cohort.
This is the patient population Elicio will prioritize in its Phase 3 development strategy, according to Monday’s release.
“DFS benefit in R0-resected patients supports Phase 3 advancement despite [the intent-to-treat] DFS miss,” H.C. Wainright said.
ELI-002 7P also “demonstrated a favorable safety profile with no treatment-related discontinuations or treatment-related deaths,” Elicio reported, adding that there were proportionally fewer adverse events in the treatment arm than in the observational arm. This profile “supports the potential for longer-term administration and combination approaches,” the biotech said.
The mixed data for ELI-002 7P come on the heels of a groundbreaking spring for the pancreatic cancer treatment space. In April, Revolution Medicines’ RAS inhibitor daraxonrasib doubled survival in a Phase 3 trial, stunning a space that has seen few advances in more than a decade. Then, ahead of the American Society of Clinical Oncology (ASCO) annual meeting last month, Immuneering reported that treatment with its MEK-targeting deep cyclic inhibitor atebimetinib elicited nearly nine additional months of survival in a mid-stage trial.
One of the deadliest malignancies, pancreatic cancer carries just a 13% survival rate five years after diagnosis.
