A pancreatic cancer vaccine missed its endpoint — and still changed the plan

A pancreatic cancer vaccine missed its primary endpoint in a randomized phase 2 trial, and the trial still matters. The results, published in Nature Medicine on 23 October 2026, describe AMPLIFY-7P: 144 patients with resected KRAS-mutated pancreatic ductal adenocarcinoma, randomized 2:1 to camupepimut (ELI-002 7P) or observation.

The primary endpoint was disease-free survival across the whole follow-up. It was not met: median 23.8 months with the vaccine versus 21.2 months with observation, hazard ratio 0.85, P = 0.5329. The prespecified bar for success was a hazard ratio below 0.70.

What the trial did see

The prespecified analysis of the six months that coincide with dosing told a different story. Disease-free survival at six months was 75.7% with camupepimut versus 61.7% with observation, a 14-point difference, with an exploratory hazard ratio of 0.55 over that window (P = 0.0557).

Two subgroups were more striking. Among the 93 patients who were ctDNA-negative at baseline, median disease-free survival was not reached in the vaccine arm versus 21.2 months in observation (HR 0.51, P = 0.0280). Among the 106 patients with no prior radiation, median disease-free survival was 23.8 versus 10.4 months (HR 0.59, P = 0.0221).

A post hoc multivariate analysis that adjusted for stage, nodal status, resection margin, CA19-9 and ctDNA suggested an adjusted hazard ratio of 0.47 for the vaccine (P = 0.0086), with ctDNA positivity the strongest adverse factor at an adjusted HR of 5.99.

The immune response is the real finding

Camupepimut targets seven mutated KRAS variants — G12D, G12R, G12V, G12A, G12C, G12S and G13D — and is designed to reach draining lymph nodes rather than circulate broadly. Among 90 evaluable patients, 89 (98.9%) developed mKRAS-specific T cell responses, with a median 44.3-fold increase over baseline and responses persisting in 63 of 66 evaluable patients at 46 weeks or more.

That immune response tracked with outcomes. A previously defined threshold of a 9.17-fold T cell increase was exceeded by 82.2% of treated patients; those above it had a median disease-free survival that was not reached versus 6.08 months below it (HR 0.22, P < 0.0001). Antigen spreading — new T cell responses against the patient's own tumour neoantigens — appeared in 13 of 15 patients evaluated.

Safety and the caveat

Camupepimut was generally well tolerated: treatment-emergent adverse events in 72.9% versus 77.1% in observation, serious events in 6.3% versus 8.3%, no withdrawals and no deaths. Related events were mostly low-grade reactogenicity such as dizziness and influenza-like symptoms.

The caveat is the one the authors name. Patients who were ctDNA-positive were overrepresented in the vaccine arm, which raises the relapse risk in that group and works against the overall result. Prior radiation also mattered: it lowered baseline lymphocytes and blunted the vaccine's T cell response (15-fold versus 58-fold).

The trial's value is therefore not a positive headline. It is a design: stratify by ctDNA, avoid or account for prior radiation, and test longer maintenance dosing, because the benefit that appeared was concentrated in the months when patients were actually being vaccinated.

Source: George, B. et al. Lymph node-targeted, mKRAS-specific amphiphile vaccine in pancreatic cancer: the randomized phase 2 AMPLIFY-7P trial. Nature Medicine, 23 October 2026.

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