RefleXion Medical’s SCINTIX biology-guided radiotherapy platform (BgRT) has shined in an observational study involving lung and bone cancer patients.
During the US-based PREMIER trial (NCT05406167), nine-month follow-up scans post-treatment revealed that 100% of patients with lung and bone metastases experienced local disease control.
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This was defined as either a complete response (CR), partial response (PR) or stable disease (SD).
Of these patients, 41% experienced CR and PRs, with 47% of those diagnosed with bone metastases and 35% of individuals with lung tumours obtaining this outcome. These impacts were observed in patients with both localised and metastatic cancer.
Meanwhile, treatment with SCINTIX BgRT was proven tolerable and safe, as no patients experienced treatment-related adverse events (TEAEs) higher than Grade 2 during the study period.
Following the positive topline outcomes of this trial, RefleXion claims that its SCINTIX platform could become a “first-in-class treatment option for localised and metastatic disease”, in a 30 September statement.
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By GlobalDataRefleXion’s CMO Sean Shirvani said: “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 tumours with imaging up to nine months after treatment represents an important step forward in expanding the reach of radiotherapy for patients with advanced cancer.”
Moving forward, RefleXion intends to expand registry enrolment and monitor patients to determine long-term treatment-related outcomes.
SCINTIX as the first of its kind
According to RefleXion, SCINTIX is the first and only precision radiotherapy system to combine positron emission tomography (PET) imaging with a linear accelerator (LINAC).
By combining these two elements, the theranostic oncology specialist claims that the system can precisely administer a dose of radiation to cancer cells without impacting the surrounding healthy tissues.
The system also differs to other next-generation radiotherapy products such as intensity-modulated radiation therapy (IMRT) and stereotactic body radiation therapy (SBRT) as it considers a patient’s individual biological information.
RefleXion claims this can help address both tumour heterogeneity and issues with motion management during the treatment delivery process.
The SCINTIX BgRT platform was first approved by the US Food and Drug Administration (FDA) in 2023 following its breakthrough device designation in late 2021.
Following its introduction to the market, RefleXion has installed its radiotherapy technology at the Beverly Hills Cancer Center, making it the first freestanding cancer centre (FSCC) to incorporate the equipment.
Meanwhile, the Centers for Medicare and Medicaid Services (CMS) announced that the agency will provide reimbursements for patients receiving SCINTIX therapy. This includes novel codes for FSCCs, as well as reimbursement for physicians.
Though SCINTIX BgRT is a first-in-class device, it may still come into competition with Siemens Healthineers-owned Varian’s TrueBeam, which also incorporates advanced imaging, precision dosing and image acquisition for treatment planning.
The device may also come into contention with Elekta’s range of precision radiotherapy units, which operate in a similar way to the SCINTIX device due to their incorporation of continuous, anatomy-specific magnetic resonance imaging with motion management.
