Lymph node-targeted, mKRAS-specific amphiphile vaccine in pancreatic cancer: the randomized phase 2 AMPLIFY-7P trial.

Authors

Ben George, Harshabad Singh, Craig E Devoe, Vincent Chung, Peter J Hosein, Andrew Hendifar, Dae Won Kim, Jennifer B Valerin, Tanios Bekaii-Saab, Dana B Cardin, Manuel Hidalgo, Pashtoon M Kasi, Alexis D Leal, Meredith Pelster, Naomi Fei, Colin D Weekes, Mark H O'Hara, Thomas J George, Syed M Kazmi, Jonathan D Mizrahi, Suresh Nair, Martin Maiers, Thian Kheoh, Gianni Amato, Jino Xavier, Julia P Snyder, Madison H Milaszewski, Xavier Cabana-Puig, James R Perry, Lisa K McNeil, Esther Welkowsky, Peter C DeMuth, Christopher M Haqq, Shubham Pant, Zev A Wainberg, Eileen M O'Reilly

Published in

Nature medicine. Oct 23, 2026. Epub Oct 23, 2026.

Abstract

Camupepimut (ELI-002 7P) drives mutated KRAS (mKRAS)-specific T cell responses that correlated with disease-free survival (DFS) and overall survival (OS) in patients with mKRAS pancreatic adenocarcinoma (PDAC) in the phase 1 AMPLIFY-201 trial. In the phase 2 AMPLIFY-7P trial, patients with stage I-III KRAS-mutated PDAC without recurrence within 6 months of standard therapy were randomized 2:1 to camupepimut (n = 96) or standard-of-care/observation (n = 48). Stratification balanced nodal status. The primary DFS endpoint was not met (median 23.8 versus 21.2 months; HR 0.85, P = 0.5329). However, prespecified and exploratory analyses were informative. A numerical DFS advantage at 6 months of 14.0% (75.7% versus 61.7%; HR 0.55, P = 0.0557) corresponded to camupepimut dosing. Post hoc multivariate Cox regression analysis of DFS indicated an improved outcome for camupepimut (adjusted HR 0.47, P = 0.0086), a worse outcome for stage III disease (adjusted HR 2.29, P = 0.0127), an elevated baseline CA19-9 (adjusted HR 3.16, P < 0.0001) and baseline circulating tumor DNA (ctDNA) positivity (adjusted HR 5.99, P < 0.0001). Prespecified subgroup analyses addressing prognostic and predictive factors suggested DFS benefit for camupepimut (ctDNA negative: HR 0.51, P = 0.0280; no prior radiation: HR 0.59, P = 0.0221). Exploratory analysis demonstrated that ex vivo mKRAS-specific T cell responses were robust (98.9%, 89/90) and associated with antigen spreading (86.7%, 13/15). In camupepimut-treated patients, mKRAS-specific T cell response >9.17-fold over baseline (82.2%, 74/90) correlated with improved DFS (HR 0.22, P < 0.0001), with the median DFS not reached versus 6.08 months for above and below 9.17-fold, respectively. Camupepimut safety was similar to observation, with grade ≥3 adverse events in 10.4% (10/96) versus 14.6% (7/48), and few serious AEs (6.3%, 6/96 versus 8.3%, 4/48; reflecting progression/surgical complication). These efficacy and immunogenicity signals will inform a refined strategy for a confirmatory phase 3 trial. ClinicalTrials.gov identifier: NCT05726864 .

PMID:
42919966
Bibliographic data and abstract were imported from PubMed on 24 Oct 2026.

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