A small clinical trial shows promising results in patients with triple-negative breast cancer who received an investigational vaccine designed to prevent tumor recurrence. The study, which was carried out in Washington University School of Medicine in St. Louis with a therapy designed by researchers from WashU Medicineis the first to report the results of this type of vaccine, known as a neoantigenic DNA vaccine, for breast cancer patients.
The vaccine was well tolerated and stimulates the immune system. The results are published in the journal ‘Genome Medicine‘.
The Phase I clinical trial involved 18 patients diagnosed with triple-negative breast cancer that was not metastatic, meaning it had not spread to other organs. Each received standard care and three doses of a personalized vaccine designed to target key mutations in their specific tumor and train immune cells to recognize and attack any cells carrying these mutations.
After treatment, 14 of the 18 patients showed immune responses to the vaccine, and after three years, 16 patients remained cancer-free. While the early-stage trial was designed to evaluate the safety of the vaccine and did not include a control group to determine efficacy, researchers analyzed historical data from patients with triple-negative breast cancer treated only with standard treatment. In that group, on average, about half of the patients remained cancer-free three years after treatment.
«These results were better than we expected», points out the main author, William E. Gillanders. “Obviously, it’s not a perfect comparison and we recognize the limitations of this type of analysis, but we continue with this vaccination strategy and we have ongoing randomized controlled trials that do a direct comparison between the standard of care plus a vaccine, versus the standard of care. attention alone. We are encouraged by what we are seeing with these patients so far».
Triple negative breast cancer is an aggressive type of tumor that grows even in the absence of the hormonal fuel that drives the growth of other types of breast cancer. To date, triple negative breast cancer has no targeted therapies and is generally treated with traditional approaches including surgery, chemotherapy, and radiotherapy. For reasons scientists are still investigating, this tumor tends to be more common among African-American patients diagnosed with breast cancer. In this trial, one-third of the participants (six of 18) were African American.
Triple negative breast cancer is an aggressive type of tumor that grows even in the absence of the hormonal fuel that drives the growth of other types of breast cancer.
This trial enrolled patients with triple-negative breast cancer who still had evidence of remaining tumor after a first round of chemotherapy. These patients have a high risk of cancer recurrence even after surgical removal of the remaining tumor. After surgical removal, the research team analyzed and compared the tumor tissue with healthy tissue from the same patient to find unique genetic mutations in the cancer cells. These mutations in a patient’s cancer cells alter proteins only in the tumor, allowing the immune system to be trained to attack the altered proteins while leaving healthy tissues intact.
Using self-designed software, the researchers selected modified proteins, called neoantigens, that were created by the patients’ tumors and that were identified as most likely to trigger a strong immune response. On average, each patient’s vaccine contained 11 neoantigens (ranging from a minimum of four to a maximum of 20) specific to their tumor.
«We are excited about the promise of these neoantigenic vaccines» says Gillanders. “We are hopeful that we can increasingly offer this type of vaccine technology to our patients and help improve treatment outcomes in patients with aggressive cancers.”
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