ELI-002 7P Misses Primary End Point in Phase 2 AMPLIFY-7P PDAC Study

The randomized phase 2 AMPLIFY-7P trial (NCT05726864) evaluating ELI-002 7P in patients with resected mutant KRAS (mKRAS)–driven pancreatic ductal adenocarcinoma (PDAC) did not meet its pre-specified primary end point of disease-free survival (DFS) in the intent-to-treat (ITT) population, according to a news release from the developer, Elicio Therapeutics.¹ Post-hoc analyses, however, identified a statistically significant DFS benefit in R0 completely resected patients, which represented approximately 84% of enrolled patients in the trial. Based on this finding, the company’s phase 3 development strategy has shifted to focus on that lower-residual-disease population.

What were the results of the phase 2 AMPLIFY-7P trial?

The trial did not achieve statistical significance for its primary DFS end point in the ITT population. Investigators noted a baseline prognostic imbalance: the ELI-002 7P arm enrolled a higher proportion of patients with R1 resection status, defined as tumor present at or within 1 mm of the surgical margin, compared with the observation arm (19% vs 10%), a known adverse prognostic factor for recurrence. Multivariable analyses confirmed R1 status as an independent adverse prognostic factor for recurrence (HR, 1.56; P = .181).

“While AMPLIFY-7P did not meet its primary end point in the intent-to-treat study population, promising efficacy signals in patients with lower residual disease burden sharpen our path forward,” stated Robert Connelly, president and chief executive officer of Elicio, in the press release.¹ “We identified the patients who benefit most, validated the biology, and demonstrated a favorable safety profile that supports extended dosing in phase 3. In a disease where no approved options exist after surgery, we believe AMPLIFY-7P demonstrates that ELI-002 7P, an mKRAS-targeted immunotherapy, can generate robust immune responses associated with improved clinical outcomes.”

Post-hoc landmark analyses showed an approximately 14% absolute improvement in DFS rates during active ELI-002 7P treatment at both 3 months (90.3% vs 76.6%; P = .022) and 6 months (75.7% vs 61.7%; P = .056), with arm separation persisting through 9 months. Among the R0 resected population (n = 121), DFS improvement was statistically significant (HR, 0.65; P = .048), with a median DFS of 23.8 months in the ELI-002 7P arm vs 12.8 months with observation. Overall survival data remained immature at the time of analysis.

mKRAS-specific T-cell responses correlated strongly with DFS outcomes. Patients with the highest immune responses experienced the most favorable clinical results: The HR for those with a T-cell fold change from baseline greater than 9.17× compared with less than 9.17× (n = 90) was 0.22 (P <.0001). CancerNetwork® previously reported that 99% of evaluable patients treated at the 4.9-mg dose achieved measurable mKRAS-specific T-cell activation, with a mean 145.3-fold and median 44.3-fold increase over baseline.²

Eileen M. O’Reilly, MD, FASCO, Winthrop Rockefeller Endowed Chair in Medical Oncology at Memorial Sloan Kettering Cancer Center, said in the release, “Future progress in pancreatic cancer will increasingly depend on precision medicine approaches that identify patients most likely to benefit from targeted and immune-based therapies. These findings show the promise of immunological targeting of mKRAS in patients previously considered to be refractory to immunotherapy.”¹

ELI-002 7P demonstrated a favorable safety profile with no treatment-related discontinuations or treatment-related deaths. Treatment was associated with proportionally fewer adverse events than standard-of-care observation.

What was the design of the AMPLIFY-7P trial?

The phase 2 AMPLIFY-7P trial enrolled 144 patients across 24 US sites. Eligible patients had resected stage I to III mKRAS-driven PDAC following completion of surgery and standard locoregional therapy and were radiographically disease-free at enrollment. Patients were randomly assigned to receive ELI-002 7P monotherapy or observation, stratified by nodal status. The pre-specified primary end point was DFS in the ITT population.

What is ELI-002 7P and how does it work?

ELI-002 7P is an off-the-shelf investigational cancer immunotherapy comprising AMP-modified mutant KRAS peptide antigens targeting the 7 most prevalent KRAS mutations. These mutations collectively drive approximately 25% of all solid tumors.

The developer’s AMP platform, originally developed at the Massachusetts Institute of Technology, is designed to deliver immunotherapy directly to lymph nodes by binding to albumin at the local injection site and traveling through lymphatic tissue. The mechanism is intended to educate, activate, and amplify cancer-specific T cells, with the goal of generating durable anti-tumor immunity.

What is the phase 3 strategy for ELI-002 7P in PDAC?

Based on the AMPLIFY-7P findings, Elicio plans to advance ELI-002 7P into a registrational phase 3 study enrolling R0 resected patients following completion of standard locoregional therapy. The design will include extended dosing beyond the initial immunization and booster regimen used in AMPLIFY-7P, with a primary end point of DFS.

“The AMPLIFY-7P trial generated important clinical and biological insights that have sharpened our development strategy and strengthened our conviction in ELI-002 7P,” said Christopher Haqq, MD, PhD, executive vice president, head of research and development, and chief medical officer of Elicio, in the press release.¹ “The stronger treatment effect observed in completely resected R0 patients, combined with the robust relationship between KRAS-specific T-cell responses and clinical outcomes, supports a clear phase 3 path focused on patients most likely to benefit from treatment.”

References

1. Elicio Therapeutics reports results from phase 2 AMPLIFY-7P study and outlines refined phase 3 development strategy for ELI-002 7P in adjuvant pancreatic cancer. News release. Elicio Therapeutics, Inc. June 15, 2026. Accessed June 16, 2026. https://tinyurl.com/nhnbks87
2. Elicio Therapeutics reports ELI-002 7P achieved robust mKRAS-specific T cell responses in 99% of evaluable patients in ongoing phase 2 AMPLIFY-7P trial. News release. Elicio Therapeutics. September 17, 2025. Accessed June 16, 2026. https://tinyurl.com/3b4f6fd9