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Camupepimut Trial Does Not Meet Primary Endpoint

lite News Desk 2 min read

Camupepimut did not meet the primary disease-free survival endpoint in AMPLIFY-7P, a phase 2 study involving 144 patients with pancreatic cancer, according to results published online by Nature Medicine on October 23, 2026. The trial compared the vaccine, also known as ELI-002 7P, with observation.

For the overall trial population, median disease-free survival was 23.8 months among vaccine recipients, compared with 21.2 months for those assigned to observation. The hazard ratio was 0.85, with a P value of 0.5329. Neither result met the study’s predefined thresholds for success: a hazard ratio under 0.70 and a P value lower than approximately 0.10.

Camupepimut is an off-the-shelf formulation combining peptide antigens for seven mutant forms of KRAS with CpG-7909, an adjuvant that stimulates immune activity. Its antigen targets are G12D, G12R, G12V, G12A, G12C, G12S and G13D. In the phase 2 trial, the dose contained 10 mg of adjuvant alongside 4.9 mg of peptide antigens.

Random assignment took place in 2024, allocating 96 participants to camupepimut and 48 to observation. Eligible patients had undergone resection for stage I–III pancreatic ductal adenocarcinoma carrying a KRAS mutation. They also had to have no recurrence visible on imaging within six months after standard locoregional treatment. Eligibility required a tumor mutation matching at least one vaccine target, but did not depend on whether minimal residual disease was detectable.

A prespecified analysis covered the 93 participants whose baseline ctDNA results were negative. In this subgroup, the vaccine group had not reached median disease-free survival, while the observation group’s median was 21.2 months. The hazard ratio was 0.51 and the P value was 0.0280. At 18 months, the proportions alive without relapse were 70% for camupepimut and 56% for observation. The paper states that these subgroup analyses lacked adjustment for multiple comparisons and that the trial lacked statistical power to test whether treatment effects differed between subgroups.

The paper also describes the vaccine platform’s delivery rationale. Its amphiphile approach links vaccine components to lipids that bind albumin, with the purpose of helping those components enter lymphatic vessels and collect in lymph nodes, where immune responses are organized. That delivery rationale does not, by itself, demonstrate a clinical benefit from camupepimut.

* This article is based on publicly available information at the time of writing.

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