TVEC is approved to treat advanced, late stage melanoma. Moffitt researchers wanted to assess whether the oncolytic virus also could be effective in combination with standard chemotherapy when given to triple-negative breast cancer patients before surgery. In a phase 2 trial of 37 patients, 45.9% achieved a response, 89% of the patients remained disease free two years post-treatment, and no recurrences occurred in patients who achieved strong responses.
The researchers also analyzed levels of immune biomarkers and assessed whether these biomarkers correlated with patient responses. They discovered that most tumor samples had higher levels of tumor fighting T cells and activation of immune signaling pathways during the first six weeks of treatment. Patients who had better responses to therapy had higher levels of CD8 T cells at week six than patients who did not respond as well to therapy.
"Our results demonstrate that TVEC, when added to systemic chemotherapy, may increase responses in high risk, early stage triple-negative breast cancer. There is evidence of robust immune activation within the tumor, and additional investigation of TVEC in combination with current chemoimmunotherapy for
is warranted," said Soliman, lead study author, medical director of Moffitt's Clinical Trials Office and senior member of Moffitt's Breast Oncology Department.Hatem Soliman, Oncolytic T-VEC virotherapy plus neoadjuvant chemotherapy in nonmetastatic triple-negative breast cancer: a phase 2 trial,
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