The co-lead investigator for a metastatic breast cancer trial combining Theraclion‘s focused ultrasound technology and immunotherapy discussed the design and rationale of the study, the France-based company reported today.
Dr. David Brenin, chief of breast surgery at the University of Virginia School of Medicine, said that although immuno-oncology has been gaining steam as a way to effectively treat lung cancer and melanoma, breast cancer has largely remained on the sidelines. He pointed out that the immune system doesn’t mount a response against most breast cancers because the body doesn’t always recognize the cells as foreign.
The PI said that fact provoked Theraclion to consider combining its high-intensity focused ultrasound system with a checkpoint inhibitor, pembrolizumab, to treat women with metastatic breast cancer.
Studies have shown that HIFU treatment triggers an immune system response in most tumors and pembrolizumab induces an immune response to some breast cancers – but neither do enough on their own, Brenin said.
In combining the two treatments, HIFU could help facilitate the infiltration of immune cells and pembrolizumab can block PD-1 receptors on cytotoxic T-cells and upregulate the immune response to breast cancer cells, according to Theraclion.
The trial is slated to enroll 12 patients beginning in October, Brenin reported. Patients in one arm will be treated first with the immunotherapy, followed by the HIFU treatment. Participants in the second arm will receive the reverse.
The study’s objectives include assessing the adverse event profile of pembrolizumab and focused ultrasound therapy in patients with metastatic breast cancer and to determine whether the addition of pembrolizumab to focused ultrasound boosts the proportion of CD8+ tumor infiltrating lymphocytes in the primary ablation zone.
The company will also compare T-cell responses at peri-ablation zones when pembrolizumab is given before or after HIFU.
“Our Echopulse echotherapy system has already been shown to be a non-invasive option to treat benign breast fibroadenomas and thyroid nodules and it is approved for these indications in several countries worldwide,” CEO David Caumartin said in prepared remarks. “Another focus area for us is the application of our echotherapy system to oncology. This clinical trial both demonstrates our commitment to this area and targets an unmet need in Stage IV metastatic breast cancer patients. We look forward to this collaboration with Dr. Brenin and the results of this initial study.”