A phase 1 trial for a vaccine targeting micrometastatic disease markers in patients treated for pancreatic or colorectal cancer has shown promising results in preventing recurrence. The study, published in Nature Medicine, involved a vaccine that targets two different KRAS mutations (G12D and G12R) and is designed as an off-the-shelf vaccine. This vaccine binds to albumin in the body and targets the lymph nodes to increase the T-cell response, potentially fighting micrometastatic diseases.
Key findings from the trial include:
- A positive T-cell response was observed in 84% of patients, and those who achieved or exceeded the median rate did not reach their median recurrence-free survival.
- No patients experienced grade 3 or higher adverse events.
- The vaccine was safe and tolerable, with the main side effect being injection-site reactions. No dose-limiting toxicities were observed.
- Among the patients, 84% saw a reduction in tumor biomarkers or ctDNA (circulating tumor DNA).
- The median T-cell response was 13 times from baseline, with patients showing a robust T-cell response not yet reaching their median recurrence-free survival.
Dr. Shubham Pant, a professor in the department of gastrointestinal medical oncology at The University of Texas MD Anderson Cancer Center, highlighted the potential impact of this vaccine in controlling micrometastatic disease and providing long-term, disease-free survival for patients. The phase 2 trial is broadening the patient population and will not require patients to be ctDNA positive. The vaccine targets more mutations with a dose level of 10 mg based on phase 1 results.
The study’s results are seen as better than expected, with high-risk patients showing exciting responses. The next phase aims to observe more robust T-cell responses in a larger number of patients and to determine whether the vaccine can delay disease recurrence and potentially cure some patients by eradicating micrometastatic disease.