---
title: "Camupepimut (ELI-002 7P) in KRAS-mutant PDAC: Phase 2 AMPLIFY-7P results"
id: "nature-1-lymph-node-targeted-mkras-specific-amphiphile-vaccine-in-pancreatic-cancer-the"
canonical_url: "https://medichelpline.com/clinical-feed/nature-1-lymph-node-targeted-mkras-specific-amphiphile-vaccine-in-pancreatic-cancer-the"
content_type: "clinical_feed_article"
specialty: "Oncology"
source_name: "Nature Medicine"
source_url: "https://www.nature.com/articles/s41591-026-04734-7"
published_at: "2026-10-23T11:56:09.000Z"
evidence_level: "Journal Feed"
license: "CC-BY-NC-4.0 / Informational Use"
---
# Camupepimut (ELI-002 7P) in KRAS-mutant PDAC: Phase 2 AMPLIFY-7P results
## Provenance & Clinical Metadata
- **Canonical URL:** https://medichelpline.com/clinical-feed/nature-1-lymph-node-targeted-mkras-specific-amphiphile-vaccine-in-pancreatic-cancer-the
- **Specialty:** [Oncology](https://medichelpline.com/clinical-feed/oncology.md)
- **Primary Source:** Nature Medicine
- **Source URL:** [Original Journal Publication](https://www.nature.com/articles/s41591-026-04734-7)
- **Published At:** 2026-10-23T11:56:09.000Z
- **Evidence Rating:** Journal Feed
## Executive GIST (TL;DR)
- The randomized phase 2 **AMPLIFY-7P** trial compared the lymph node–targeted amphiphile vaccine **camupepimut** (ELI-002 7P) versus standard-of-care/observation in resected, stage I–III **KRAS**-mutant pancreatic ductal adenocarcinoma (**PDAC**). - Patients without recurrence within 6 months after standard therapy were randomized 2:1 to vaccine (n = 96) or observation (n = 48); nodal status was used for stratification. - The primary disease-free survival (DFS) endpoint was not met: median DFS 23.8 versus 21.2 months (HR 0.85, P = 0.5329). Short-term signal at 6 months favored camupepimut (75.7% vs 61.7%; HR 0.55, P = 0.0557) and aligned with dosing schedule. - Post hoc multivariate Cox regression adjusted for prognostic factors found improved DFS with camupepimut (adjusted HR 0.47, P = 0.0086); worse outcomes associated with stage III disease, elevated baseline CA19-9 and ctDNA positivity. - Prespecified subgroup analyses suggested DFS benefit among patients who were ctDNA negative (HR 0.51, P = 0.0280) and those without prior radiation (HR 0.59, P = 0.0221). - Ex vivo **mKRAS**-specific T cell responses were robust in treated patients (98.9%, 89/90) and correlated with antigen spreading (86.7%, 13/15); a >9.17-fold T cell response over baseline (observed in 82.2%, 74/90) associated strongly with improved DFS (HR 0.22, P < 0.0001). - Safety was comparable to observation: grade ≥3 adverse events 10.4% in vaccine arm versus 14.6% in observation; serious AEs were few and reflected progression or surgical complications. - Investigators reported that these efficacy and immunogenicity signals will inform a refined confirmatory phase 3 strategy; the source did not report specific phase 3 design details or dosing modifications.
## Clinical Analysis & Structured Key Points
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O’Hara](https://www.nature.com/articles/s41591-026-04734-7#auth-Mark_H_-O_Hara-Aff16) [ORCID: orcid.org/0000-0003-2751-6122](https://orcid.org/0000-0003-2751-6122)[16](https://www.nature.com/articles/s41591-026-04734-7#Aff16), * [Thomas J. George](https://www.nature.com/articles/s41591-026-04734-7#auth-Thomas_J_-George-Aff17) [ORCID: orcid.org/0000-0002-6249-9180](https://orcid.org/0000-0002-6249-9180)[17](https://www.nature.com/articles/s41591-026-04734-7#Aff17), * [Syed M. Kazmi](https://www.nature.com/articles/s41591-026-04734-7#auth-Syed_M_-Kazmi-Aff18) [ORCID: orcid.org/0000-0002-3367-367X](https://orcid.org/0000-0002-3367-367X)[18](https://www.nature.com/articles/s41591-026-04734-7#Aff18), * [Jonathan D. Mizrahi](https://www.nature.com/articles/s41591-026-04734-7#auth-Jonathan_D_-Mizrahi-Aff19)[19](https://www.nature.com/articles/s41591-026-04734-7#Aff19), * [Suresh Nair](https://www.nature.com/articles/s41591-026-04734-7#auth-Suresh-Nair-Aff20)[20](https://www.nature.com/articles/s41591-026-04734-7#Aff20), * [Martin Maiers](https://www.nature.com/articles/s41591-026-04734-7#auth-Martin-Maiers-Aff21) [ORCID: orcid.org/0000-0002-0198-2064](https://orcid.org/0000-0002-0198-2064)[21](https://www.nature.com/articles/s41591-026-04734-7#Aff21), * [Thian Kheoh](https://www.nature.com/articles/s41591-026-04734-7#auth-Thian-Kheoh-Aff22)[22](https://www.nature.com/articles/s41591-026-04734-7#Aff22), * [Gianni Amato](https://www.nature.com/articles/s41591-026-04734-7#auth-Gianni-Amato-Aff22)[22](https://www.nature.com/articles/s41591-026-04734-7#Aff22), * [Jino Xavier](https://www.nature.com/articles/s41591-026-04734-7#auth-Jino-Xavier-Aff22)[22](https://www.nature.com/articles/s41591-026-04734-7#Aff22), * [Julia P. Snyder](https://www.nature.com/articles/s41591-026-04734-7#auth-Julia_P_-Snyder-Aff22)[22](https://www.nature.com/articles/s41591-026-04734-7#Aff22), * [Madison H. Milaszewski](https://www.nature.com/articles/s41591-026-04734-7#auth-Madison_H_-Milaszewski-Aff22)[22](https://www.nature.com/articles/s41591-026-04734-7#Aff22), * [Xavier Cabana-Puig](https://www.nature.com/articles/s41591-026-04734-7#auth-Xavier-Cabana_Puig-Aff22)[22](https://www.nature.com/articles/s41591-026-04734-7#Aff22), * [James R. Perry](https://www.nature.com/articles/s41591-026-04734-7#auth-James_R_-Perry-Aff22)[22](https://www.nature.com/articles/s41591-026-04734-7#Aff22), * [Lisa K. McNeil](https://www.nature.com/articles/s41591-026-04734-7#auth-Lisa_K_-McNeil-Aff22)[22](https://www.nature.com/articles/s41591-026-04734-7#Aff22), * [Esther Welkowsky](https://www.nature.com/articles/s41591-026-04734-7#auth-Esther-Welkowsky-Aff22)[22](https://www.nature.com/articles/s41591-026-04734-7#Aff22), * [Peter C. DeMuth](https://www.nature.com/articles/s41591-026-04734-7#auth-Peter_C_-DeMuth-Aff22)[22](https://www.nature.com/articles/s41591-026-04734-7#Aff22), * [Christopher M. Haqq](https://www.nature.com/articles/s41591-026-04734-7#auth-Christopher_M_-Haqq-Aff22) [ORCID: orcid.org/0000-0001-8600-9548](https://orcid.org/0000-0001-8600-9548)[22](https://www.nature.com/articles/s41591-026-04734-7#Aff22), * [Shubham Pant](https://www.nature.com/articles/s41591-026-04734-7#auth-Shubham-Pant-Aff23) [ORCID: orcid.org/0000-0001-9281-480X](https://orcid.org/0000-0001-9281-480X)[23](https://www.nature.com/articles/s41591-026-04734-7#Aff23), * [Zev A. Wainberg](https://www.nature.com/articles/s41591-026-04734-7#auth-Zev_A_-Wainberg-Aff24) [ORCID: orcid.org/0000-0002-7142-1246](https://orcid.org/0000-0002-7142-1246)[24](https://www.nature.com/articles/s41591-026-04734-7#Aff24) & * … * [Eileen M. O’Reilly](https://www.nature.com/articles/s41591-026-04734-7#auth-Eileen_M_-O_Reilly-Aff25) [ORCID: orcid.org/0000-0002-8076-9199](https://orcid.org/0000-0002-8076-9199)[25](https://www.nature.com/articles/s41591-026-04734-7#Aff25) Show authors [_Nature Medicine_](https://www.nature.com/nm) (2026) [Cite this article](https://www.nature.com/articles/s41591-026-04734-7#citeas) Save article [ View saved research ](https://www.nature.com/saved-research) ## 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_ 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](http://clinicaltrials.gov/ct2/show/NCT05726864). ### Explore related subjects Discover the latest articles and news in related subjects. * [Drug development](https://www.nature.com/subjects/drug-development) * [Immunotherapy](https://www.nature.com/subjects/immunotherapy) * [Pancreatic cancer](https://www.nature.com/subjects/pancreatic-cancer) * [Immunotherapy Strategies for Pancreatic Cancer](https://www.nature.com/subjects/immunotherapy-strategies-for-pancreatic-cancer) ## Main Pancreatic adenocarcinoma (PDAC) is the third leading cause of cancer deaths in the USA, with roughly 67,000 new cases diagnosed and 53,000 deaths each year[1](https://www.nature.com/articles/s41591-026-04734-7#ref-CR1 "Siegel, R. L., Kratzer, T. B., Wagle, N. S., Sung, H. & Jemal, A. Cancer statistics, 2026. CA Cancer J. Clin. 76, e70043 \(2026\)."). Surgery (pancreatectomy) is the only curative option in PDAC. However, prognosis remains poor owing to a high propensity for locoregional and hepatic recurrence following pancreatectomy, with a 5-year survival of only 15–17.4% (refs. [2](https://www.nature.com/articles/s41591-026-04734-7#ref-CR2 "Bengtsson, A., Andersson, R. & Ansari, D. The actual 5-year survivors of pancreatic ductal adenocarcinoma based on real-world data. Sci. Rep. 10, 16425 \(2020\)."),[3](https://www.nature.com/articles/s41591-026-04734-7#ref-CR3 "Latenstein, A. E. J. et al. Conditional survival after resection for pancreatic cancer: a population-based study and prediction model. Ann. Surg. Oncol. 27, 2516–2524 \(2020\).")). Immune checkpoint blockade (ICB) has not been effective in PDAC, probably owing to the immunosuppressive tumor microenvironment and lack of tumor-specific T cell responses. Mutations in KRAS are truncal, execute driver functions and occur in approximately 90–95% of PDAC, making them attractive targets for immunotherapy. RAS inhibitors are effective and improved overall survival (OS) in second-line metastatic PDAC, but the development of primary and secondary resistance to RAS inhibitors leads to disease progression, limiting patient benefit[4](https://www.nature.com/articles/s41591-026-04734-7#ref-CR4 "Aronchik, I. et al. Acquired resistance to the RAS\(ON\) multi-selective inhibitor daraxonrasib guides rational combination therapy strategies in pancreatic cancer. Nat. Med. 32, 2865–2877 \(2026\)."),[5](https://www.nature.com/articles/s41591-026-04734-7#ref-CR5 "O’Reilly, E. M. et al. Daraxonrasib or chemotherapy in previously treated metastatic pancreatic cancer. N. Engl. J. Med. 395, 325–337 \(2026\)."). Conversely, T cells targeting mutated KRAS (mKRAS) could result in durable clinical responses and are unlikely to have off-target toxicity, as normal tissue does not express mKRAS. mKRAS-specific T cells have been identified in patients, and adoptive T cell therapy with G12D-specific, C*08:02-restricted T cells has led to tumor regression in patients; however, these therapies are logistically challenging, resource intensive and human leukocyte antigen (HLA)-restricted to limited populations[6](https://www.nature.com/articles/s41591-026-04734-7#ref-CR6 "Tran, E. et al. T-cell transfer therapy targeting mutant KRAS in cancer. N. Engl. J. Med. 375, 2255–2262 \(2016\)."),[7](https://www.nature.com/articles/s41591-026-04734-7#ref-CR7 "Leidner, R. et al. Neoantigen T-cell receptor gene therapy in pancreatic cancer. N. Engl. J. Med. 386, 2112–2119 \(2022\)."),[8](https://www.nature.com/articles/s41591-026-04734-7#ref-CR8 "Levin, N. et al. Identification and validation of T-cell receptors targeting RAS hotspot mutations in human cancers for use in cell-based immunotherapy. Clin. Cancer Res. 27, 5084–5095 \(2021\)."),[9](https://www.nature.com/articles/s41591-026-04734-7#ref-CR9 "Conn, B. P. et al. Generation of T cell responses against broad KRAS hotspot neoantigens for cell therapy or TCR discovery. Cell Rep. Methods 5, 101049 \(2025\)."). Alternatively, given their prevalence and immunogenicity, KRAS mutations are ideal potential targets for off-the-shelf cancer vaccines designed to generate endogenous mKRAS-specific responses[10](https://www.nature.com/articles/s41591-026-04734-7#ref-CR10 "Haanen, J. B., Schumacher, T. N. M., Kagan, J. C., Fritsch, E. F. & Wu, C. J. Publisher Correction: Clinical development of cancer vaccines. Nat. Med. 32, 1557–1557 \(2026\)."),[11](https://www.nature.com/articles/s41591-026-04734-7#ref-CR11 "Wainberg, Z. A. et al. Lymph node-targeted, mKRAS-specific amphiphile vaccine in pancreatic and colorectal cancer: phase 1 AMPLIFY-201 trial final results. Nat. Med. 31, 3648–3653 \(2025\)."),[12](https://www.nature.com/articles/s41591-026-04734-7#ref-CR12 "Pant, S. et al. Lymph-node-targeted, mKRAS-specific amphiphile vaccine in pancreatic and colorectal cancer: the phase 1 AMPLIFY-201 trial. Nat. Med. 30, 531–542 \(2024\)."),[13](https://www.nature.com/articles/s41591-026-04734-7#ref-CR13 "Carbone, D. P. et al. Immunization with mutant p53- and K-ras-derived peptides in cancer patients: immune response and clinical outcome. J. Clin. Oncol. 23, 5099–5107 \(2005\)."),[14](https://www.nature.com/articles/s41591-026-04734-7#ref-CR14 "Palmer, D. H. et al. TG01/GM-CSF and adjuvant gemcitabine in patients with resected RAS-mutant adenocarcinoma of the pancreas \(CT TG01-01\): a single-arm, phase 1/2 trial. Br. J. Cancer 122, 971–977 \(2020\)."),[15](https://www.nature.com/articles/s41591-026-04734-7#ref-CR15 "Rahma, O. E. et al. The immunological and clinical effects of mutated ras peptide vaccine in combination with IL-2, GM-CSF, or both in patients with solid tumors. J. Transl. Med. 12, 55 \(2014\)."),[16](https://www.nature.com/articles/s41591-026-04734-7#ref-CR16 "Gjertsen, M. K. et al. Ex vivo ras peptide vaccination in patients with advanced pancreatic cancer: results of a phase I/II study. Int. J. Cancer 65, 450–453 \(1996\)."). A poly-ICLC ad
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> Always verify dosing, contraindications, and regulatory alerts against official product labeling and primary regulatory sources before clinical decision-making.