RefleXion Announces Real-World Evidence Outcomes Registry to Evaluate Treatment Impact on all Stages of Cancer

PREMIER registry to enroll a minimum of 750 patients and include all solid tumor cancers

RefleXion Medical, a therapeutic oncology company pioneering the use of biology-guided radiotherapy (BgRT)* for all stages of cancer, today announced the enrollment of the first patient into its PREMIER registry, a prospective, real-world evidence clinical outcomes registry for patients with all stages of cancer, at the University of Texas (UT) Southwestern in Dallas.

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The RefleXion® X1 radiotherapy system is the first-ever system with onboard fast fan-beam KVCT. Photo credit: Craig Takahashi, City of Hope.

The PREMIER registry was created to collect data to demonstrate the impact of the RefleXion® X1 radiotherapy system, the first-ever system with onboard fast fan-beam KVCT, on patients with all solid tumor and lymphoma cancer types. The registry will expand to include BgRT procedures, a new radiotherapy treatment modality that uses signals detected from positron emission tomography (PET) to guide radiotherapy. The X1 is the first and only system designed with onboard PET detectors. The PREMIER registry will assess health-related quality of life, acute and long-term side effects in patients, and cancer-related outcomes.

“We believe that adapting radiotherapy plans based on how the tumor responds to the first radiation dose will be a key component in bringing together radiotherapy with drug therapies, such as targeted and immune-oncology agents,” said Tu Dan, M.D., assistant professor in the Department of Radiation Oncology at UT Southwestern Medical Center. “However, to fully understand the utility of this approach, robust and accurate data collected through longitudinal endpoints in prospective registries, such as RefleXion’s PREMIER registry, are imperative.”

The PREMIER registry will include extensive baseline data as well as follow-up data collected at the end of treatment, and then again at three, six, nine, 12, 18 and 24 months. The registry will enroll a minimum of 750 patients from a minimum of four sites throughout the United States.

“Our prospective registry will capture and organize an unprecedented level of data including patient, demographic, tumor, biomarker, imaging and treatment information for all stages of cancer,” said Sean Shirvani, M.D., MPH, chief medical officer at RefleXion. “Our hope is that collecting this rich repository of information before, during, and after treatment will enable our clinical partners to investigate and identify the factors that best determine cancer outcomes, which may then arm patients with the information they need to make better decisions around their care.”

Prospective registries define specific information and characteristics in advance, before data collection or the impacts of a treatment are known, including the check-in interval for patient follow-up. Known as longitudinal data over time, this improves data accuracy because it minimizes the dependency on patient recall. Therefore, prospective registries can draw closer associations between the treatment delivered and a patient’s outcome.

About RefleXion Medical

RefleXion is a privately-held company developing the first biology-guided radiotherapy system, a significant change in strategy from single tumor therapy to the ability to one day treat multiple tumors in the same treatment session in cancers that have metastasized. Currently, the RefleXion X1 machine is cleared for the delivery of stereotactic body radiotherapy (SBRT), stereotactic radiosurgery (SRS) and intensity modulated radiotherapy (IMRT). The company is also developing BgRT, which incorporates positron-emission tomography (PET) imaging data to enable tumors to continuously signal their location. The BgRT technology will synchronize these data with the linear accelerator to direct radiotherapy to tumors with sub-second latency.

*The RefleXion® X1 is cleared for SBRT/SRS/IMRT. BgRT is pending regulatory review and is not commercially available.

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