Varian Receives IDE for FAST-02 Trial of Flash Technology

June 27, 2022—Varian, a Siemens Healthineers company, announced that the FDA granted an investigational device exemption (IDE) to advance the company’s Flash clinical research program with the FAST-02 clinical trial. FAST-02 is the feasibility study of Flash therapy for the treatment of symptomatic bone metastases.

The company noted that data from the first-ever human clinical trial of Flash, FAST-01, was used to support the approval of the FAST-02 study and will be reported later this year. The FAST-02 clinical trial builds on the clinical evidence from FAST-01 and will include bone metastases in the chest, providing critical insights into the clinical use of Flash treatment for cancer metastases.

According to Varian, FAST-02 is expected to enroll 10 patients with painful thoracic bone metastases and aims to evaluate treatment-related side effects and efficacy of treatment, which will be assessed using trial participants’ reported pain relief.

FAST-02 will be led by Principal Investigator John C. Breneman, MD, who is Medical Director of the Cincinnati Children’s/UC Health Proton Therapy Center, University of Cincinnati Cancer Center in Cincinnati, Ohio. The trial will be conducted at the Cincinnati Children’s/UC Health Proton Therapy Center.

Like the FAST-01 trial, FAST-02 was designed with input from leading scientific experts from the FlashForward Consortium, a 25-member group of institutions from around the world, includes over 150 experts in radiation oncology, translational sciences, and medical physics.

“For the last decade, radiation oncologists have been exploring Flash therapy as an important opportunity to create a paradigm shift in the way we treat patients,” commented Dr. Breneman in the company’s press release. “The FAST-01 trial laid the groundwork for the approval of FAST-02, and we are excited to continue the clinical research and evaluate Flash therapy in a new patient cohort.”

In connection with the FAST-02 clinical trial, the Varian ProBeam system’s proton particle accelerator has been modified to deliver Flash therapy, and Varian’s Eclipse treatment planning system has also been modified to create plans for the Flash treatments. Varian advanced the development of Flash therapy as an integrated, end-to-end solution that includes innovations in treatment planning, quality assurance, and therapy delivery technologies.

Deepak “Dee” Khuntia, MD, who is Senior Vice President and Chief Medical Officer of Varian, stated in the press release, “Preclinical research of Flash therapy indicates using ultra-high dose rates may be less toxic to patients overall and enhances sparing of adjacent healthy tissue. The FAST-02 study will advance our work toward an important proof of concept, particularly in deep-seated tumors. We are eager to build on our clinical understanding of Flash therapy as we continue our work to transform cancer care.”

Varian explained that Flash therapy is an experimental treatment modality that delivers radiation therapy at ultra-high dose rates in typically < 1 second and may be more than 100 times faster compared to conventional radiation therapy.

The company noted that the concept of ultra-high dose rate radiation delivery has been studied for many years. Varian’s research and development efforts to advance evidence for proton Flash therapy include investing in bench and preclinical research and supporting the FlashForward Consortium.