Pancreatic cancer vaccine camupepimut fails to meet primary endpoint in phase 2 trial

What AMPLIFY-7P measured

The randomised phase 2 trial enrolled 144 patients with KRAS-mutated pancreatic cancer, stages 1 to 3, all of whom had already had surgery and chemotherapy. Imaging showed no visible disease in any of them at entry. Researchers assigned 96 to camupepimut and kept 48 under observation as controls. Scientists at Mayo Clinic led the study, and Elicio Therapeutics, the biotechnology company developing the vaccine, funded it.

For patients whose tumour has been removed and treated with chemotherapy, few options exist to stop it coming back. By some estimates, malignant tumours in the pancreas recur in up to 80% of patients. Pancreatic cancer accounts for around 3% of cancer cases a year in the United States, according to the American Cancer Society. About 70,000 Americans are diagnosed annually, NPR reported.

Camupepimut is not approved and is available only through clinical trials.

Of the 90 vaccinated patients who could be assessed, 89 developed increased T-cell responses against mutated KRAS, or 98.9%. In 74 of those 90, 82.2%, the T-cell response was more than nine times the level measured before vaccination. The comparison is against each patient's own baseline, not controls. Median disease-free survival was 23.8 months in the vaccine group against 21.2 months for controls, a difference the researchers did not find statistically significant.

An immune response is not a survival benefit

At six months, 75.7% of the vaccine group remained disease-free against 61.7% of controls, a difference that did not reach statistical significance. Over the full follow-up period the difference was also not statistically significant. Stronger immune responses were associated with longer periods without the cancer returning, the researchers reported, but an association does not establish that the vaccine caused the longer period. The study did not demonstrate a definitive clinical benefit.

The vaccine was generally well tolerated, with no treatment-related deaths or adverse events that led participants to discontinue treatment, the researchers reported. Participants who had no detectable circulating tumour DNA at the start of the trial appeared to have better disease-free survival after vaccination.

Ben George, an oncologist at Mayo Clinic and the study's lead author, said pancreatic cancer has historically been very difficult to treat with immunotherapy.

How the vaccine is built

Camupepimut, also called ELI-002 7P, targets seven common KRAS mutations. It is a therapeutic vaccine, given after surgery and chemotherapy, not a preventive shot. KRAS mutations appear in around 90% of pancreatic ductal adenocarcinoma cases, the most common form of the disease.

The vaccine carries protein fragments that help T cells recognise KRAS changes, and it is designed to reach the lymph nodes, where immune cells are activated. Mutations in the gene can push cells to multiply without normal control and form tumours. Camupepimut is an off-the-shelf product, not a personalised vaccine built from an individual tumour. Its reach is limited. It applies only to patients whose tumour carries one of the seven mutations covered.

The earlier signal

A 2024 study gave up to 10 shots of ELI-002 to 25 people with pancreatic or colorectal cancer, targeting KRAS mutations. Most participants' T cells showed a significant response, especially at the highest doses, and that response was linked to a decrease in signs of cancer activity and an 86% drop in the risk of cancer coming back or leading to death.

What happens next

The planned phase 3 trial will add extra boosters of the vaccine and may test it in combination with other cancer treatments, ScienceAlert reported.

"We've shown that we can teach the immune system to recognize these KRAS mutations," George said. "The next step is finding out whether doing that can change the course of the disease for patients."