On September 30, 2025 RefleXion Medical, an external‑beam theranostic oncology company, reported first results from the PREMIER Registry (NCT05406167) evaluating its SCINTIX biology-guided radiotherapy, or BgRT, platform in patients with lung and bone tumors (Press release, RefleXion, SEP 30, 2025, View Source [SID1234656359]). The findings, presented at the 2025 ASTRO Annual Meeting, showed local control of 100 percent at nine months post-treatment with no reported Grade 2 or higher adverse events. The data represent the first prospective, multi-institutional evidence of SCINTIX therapy’s clinical impact.
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"The PREMIER Registry findings mark a milestone for our field," said Sean Shirvani, M.D., MPH, chief medical officer at RefleXion. "We are beginning to see the clinical translation of a technology that can autonomously guide radiation based on real-time biology. Achieving 100% local control in both lung and bone tumors with imaging up to nine months after treatment, without significant toxicity, represents an important step forward in expanding the reach of radiotherapy for patients with advanced cancer."
By Feb. 25, 2025, five cancer centers had enrolled 45 patients in the registry, with 28 providing follow-up imaging for analysis. Fifteen patients were treated for lung tumors, including early-stage and metastatic disease, and 13 for bone metastases. The median patient age was 69.5 years, with 39% female.
Across 39 follow-up scans, investigators reported a local control rate – defined as complete response (CR), partial response (PR), or stable disease (SD) – of 100% across available follow-up imaging. Tumor response rates (CR+PR) were 41% overall, including 47% for bone metastases and 35% for lung tumors. No Grade 2 or higher treatment-related adverse events were observed.
RefleXion plans to expand registry enrollment and continue long-term follow-up to strengthen the dataset and evaluate correlations between treatment parameters, imaging metrics and patient outcomes.
These early results underscore RefleXion’s goal of establishing SCINTIX therapy as a first-in-class treatment option for both localized and metastatic disease. As the registry grows, the company expects the evidence to further support BgRT’s integration into routine cancer care.
RefleXion (booth #1433) is also presenting early results characterizing performance of its future, next-generation platform1 that offers a 20-fold increase in PET sensitivity, which may increase patient eligibility for SCINTIX therapy. Presentations will be held every 30 minutes in the RefleXion booth during exhibit hours.