Dr Devoe on Safety and Efficacy Data for ELI-002 7P in KRAS+, MRD+ PDAC and CRC

Craig E. Devoe, MD, MS, discusses data for ELI-002 7P in patients with MRD-positive pancreatic and colorectal cancers after locoregional therapy.

Craig E. Devoe, MD, MS, chief, Division of Medical Oncology and Hematology, R. J. Zuckerberg Cancer Center, chief, Hematology-Oncology Service, Long Island Jewish Medical Center and North Shore University Hospital. discusses findings from the phase 1a AMPLIFY-7P trial (NCT05726864), a multicenter study evaluating the safety, immunogenicity, and preliminary antitumor activity of ELI-002 7P in patients with pancreatic ductal adenocarcinoma (PDAC) and colorectal cancer (CRC) harboring KRAS mutations who are minimal residual disease (MRD) positive after standard locoregional treatments.

ELI-002 7P is an expanded spectrum vaccine that includes lymph node–targeted, amphiphile-modified KRAS G12D/V/R/C/S/A– and G13D–mutant peptides with an amphiphile-modified CpG oligonucleotide adjuvant intended to expand polyfunctional mutant KRAS-specific T cells.

AMPLIFY-7P enrolled patients with PDAC or CRC who underwent prior locoregional therapy that included surgery and chemotherapy, with or without radiation. They needed to harbor a KRAS G12D/R/V/C/S/A or G13D mutation; have no evidence of disease on imaging; and have MRD as detected via circulating tumor DNA (ctDNA) and/or serum tumor biomarkers.

The treatment protocol involved administering a fixed dose of Amph-CpG-7909 combined with two different doses of ELI-002 7P (1.4 mg and 4.9 mg), administered subcutaneously. Patients received 4 weekly doses, followed by 2 doses every 2 weeks, for a total of 6 doses, followed by a 2-week observation period before 4 additional booster doses were administered, Devoe says, The primary objective was to establish the safety profile of this regimen, assess immunogenicity by measuring T-cell responses, and evaluate preliminary antitumor effects.

Findings presented at the 2024 ASCO Annual Meeting showed that no dose-limiting toxicities occurred in patients treated at either dose level (n = 14). Devoe notes that local injection site reactions were observed; however, these were transient and decreased in intensity over time. Any-grade treatment-emergent adverse effects included fatigue (42.9%), malaise (21.4%), diarrhea (21.4%), abdominal distension (14.3%), and abdominal pain (14.3%). Notably, no instances of cytokine release syndrome or T cell–related toxicities were reported.

From an immunogenicity standpoint, the T-cell response rate was 100%, and the median fold change was 23.6. Further, both CD8-positive T-cell and CD4-positive T-cell responses were observed in 63.6% and 45.5% of patients, respectively.

Related Videos
Jerôme Fayette, MD, PhD, medical oncologist, Centre Léon Bérard
Jun Gong, MD, associate professor, medicine, medical oncologist, Gastrointestinal Disease Research Group, Pancreatic Cancer Research Group, Urologic Oncology Program, Samuel Oschin Comprehensive Cancer Institute, Cedars-Sinai
Rebecca Klisovic, MD
Kedar Kirtane, MD, assistant member, Department of Head and Neck-Endocrine Oncology; medical director, Solid Tumor Cellular Therapy, Moffitt Cancer Center
Rohan Garje, MD
Cynthia Ma, MD, PhD
Arya Mariam Roy, MBBS
Karl Semaan, MD, MSc
Bradley McGregor, MD, discusses findings from a phase 1b study of abemaciclib  in clear cell renal cell carcinoma.
Marc-Oliver Grimm, MD