Focused ultrasound and immunotherapy drug at center of new trial

By Paul Basilio, MDLinx
Published October 25, 2017

Key Takeaways

A clinical trial at the University of Virginia Health System is using focused ultrasound in combination with a cancer immunotherapy drug in patients with metastatic breast cancer. It is the first trial of its kind.

The non-invasive focused ultrasound therapy is intended to ablate a portion of the primary tumor or metastatic tumors in conjunction with the cancer immunotherapy drug pembrolizumab. The trial is led by Patrick Dillon, MD, associate professor of hematology and oncology, and David Brenin, MD, FACS, associate professor of surgery and chief of breast surgery.

Pembrolizumab is not approved by the FDA for the treatment of breast cancer and it is considered investigational for the purposes of this study.

“The immune system does not recognize most breast cancers as invading or foreign cells, so the body does not mount an immune response against them,” said Dr. Brenin. “Focused ultrasound induces a local immune response and may have the ability to change that paradigm, enabling a medication like [pembrolizumab] to make a difference.”

Preclinical studies have suggested that focused ultrasound can “unmask” breast cancer cells and make them visible to the immune system. In the current study, the hypothesis is that application of focused ultrasound to the tumor will initiate a local immune response that will draw anti-cancer immune cells to the area.

Pembrolizumab could then prevent the tumor cells from deactivating the immune cells, allowing the immune cells to continue killing cancerous cells.

The EchoPulse system from Theraclion will be used to deliver the focused ultrasound treatment that will target up to 50% of the breast tumor. Fifteen women will be enrolled in the study; patients will be randomized to receive their first dose of pembrolizumab either prior to or following focused ultrasound treatment.

“Currently, women with metastatic breast cancer have to endure lifelong treatments such as chemotherapy or anti-estrogen therapy that impart toxicity,” said Dr. Dillon. “We hope that this study will help advance the application of immune therapies as we aim to create more durable responses in women with breast cancer.”

According to Neal F. Kassell, MD, chairman of the Focused Ultrasound Foundation, cancer immunotherapy has emerged in recent years as one of the most promising areas of medicine.

“One central initiative of our Foundation is dedicated to exploring how focused ultrasound can enhance its effects even further, for more patients,” he said. “This is the first time these therapies have been approved by the FDA to be used in combination in patients, and we are proud to support this innovative trial.”

Funding for the trial was provided by the Focused Ultrasound Foundation and the Commonwealth of Virginia.

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