- A group of researchers recently conducted a randomized phase 2 trial for a pancreatic cancer vaccine.
- They found that the vaccine triggered an immune response in almost 99% of participants.
- Although the vaccine produced a strong immune response, the research team did not see a statistically significant improvement in disease-free survival.
Surgery and chemotherapy can treat pancreatic cancer, but the cancer cells may stay in the body and
Researchers are studying whether cancer vaccines could help the immune system identify and destroy these remaining cells, potentially reducing the risk of recurrence.
A new study examined whether the experimental vaccine campuppimut could help reduce this risk in people who have already had surgery and chemotherapy.
According to the
Pancreatic cancer is one of the
Changes in the KRAS The gene is present in about 90% of PDAC cases, which can cause cells to grow out of control and contribute to the development of cancer.
It is with this in mind that researchers developed the campuppimut vaccine to target several common diseases. KRAS mutations. The vaccine releases its components into the lymph nodes, where it helps immune cells recognize cancer cells. KRAS mutations.
Researchers described campupepimut as a “commercially available” treatment that could potentially work for people with multiple KRAS mutations.
Unlike personalized cancer vaccines, which are developed based on an individual’s tumor, this approach could make the vaccine more widely available.
For the AMPLIFY-7P randomized phase 2 trial, the research team recruited 144 participants with KRAS-mutated pancreatic cancer (stages 1 to 3). They underwent surgery and chemotherapy treatment before enrolling in the trial.
None of the participants showed signs of recurrence on imaging tests when they entered the trial.
The researchers divided the participants into two groups:
- vaccinated group (96 participants)
- control group (48 participants).
The team focused on disease-free survival, or how long they lived without their cancer coming back or dying. They also looked at immune responses and the safety of treatments.
The researchers found that the vaccine triggered a strong immune response in almost everyone in the vaccinated group.
The vaccine activated T cells that target KRAS mutations in almost 99% of the test group. The vaccine also increased T cell activity more than ninefold in 82.2% of those evaluated.
Despite these strong immune responses, the vaccine did not meet the study’s primary endpoint of disease-free survival.
Median disease-free survival was 23.8 months in the vaccinated group, compared to 21.2 months in the observation group.
At 6 months, 75.7% of the vaccinated group remained disease-free, compared to 61.7% of the control group.
Although this difference suggests a possible early benefit, it did not reach statistical significance. The researchers also did not find a statistically significant improvement in disease-free survival over the entire follow-up period.
After conducting further analyses, researchers believe that some people may benefit more from the vaccine.
For example, participants who did not have detectable circulating tumor DNA (ctDNA) at the start of the trial appeared to experience better disease-free survival after vaccination. Detectable ctDNA may indicate that cancer cells remain in the body after treatment.
The team also observed an association between stronger T cell responses and longer disease-free survival.
Researchers reported that the vaccine was generally well tolerated, with no deaths or treatment-related adverse events causing any of the participants to discontinue treatment.
The team plans to study campupepimut further in a phase 3 trial, potentially using additional booster doses and combining the vaccine with other treatments.
Anton Bilchik, MD, PhD, a surgical oncologist, chief of medicine and director of the gastrointestinal and hepatobiliary program at Providence Saint John’s Cancer Institute, who was not involved in the study, said Medical news today that the results are “extremely important” despite the absence of a statistically significant survival benefit.
“This shows that a very resistant cancer such as pancreatic cancer is capable of responding to a vaccine provided the patient mounts a strong immune response,” Bilchik explained.
He noted that the small study size and limited vaccination period may have influenced the results.
“We must therefore interpret these results with optimism, recognizing that more studies need to be done to evaluate the benefit in different subgroups of patients and to determine the survival benefit when the vaccine is administered over a longer period of time,” Bilchik told us.
Jason Williams, MD, founder and director of interventional oncology and immunotherapy at the Williams Cancer Institute, who was also not involved in the study, explained that activating the immune system is only part of the challenge.
“Seeing the cancer is the first step,” Williams said. “Cleaning it is another.”
He suggested that combining the vaccine with other treatments could help overcome pancreatic cancer’s ability to suppress the immune system.
“The immune system needs more than one signal: It needs to see the target and the tumor needs to stop stopping it. A larger randomized trial will need to show patients that they stay cancer-free longer.”
–Jason Williams, MD
Gn Health
