OncoBeta® GmbH, a medical device company specialising in innovative epidermal radioisotope therapies, has announced 12-months interim results from its international Phase IV, multi-centre clinical trial evaluating the efficacy and safety of Rhenium-SCT® (Skin Cancer Therapy) in patients with non-melanoma skin cancer (NMSC).
The EPIC-Skin Study (Efficacy of Personalised Irradiation with Rhenium-SCT for the Treatment of Non-Melanoma Skin Cancer) is designed to assess treatment efficacy and safety, as well as key patient-reported outcomes including quality of life, treatment comfort, and cosmetic results.1 The study is based on the clinically validated effect of the beta-emitter rhenium-188 in treating basal cell carcinoma (BCC) and squamous cell carcinoma (SCC).
Treatment data is available for 184 adult patients (with 254 lesions) across 7 study centres in Australia, Austria, Germany, the United Kingdom, and South Africa. All participants had histologically confirmed stage I or II NMSC. The median patient age was 70.3 years (range 27–95 years), and 53.3% of participants were male. Patients had one (71.2%), two (19.6%), or three (9.2%) lesions treated, which were located on the head & neck (11.8%), trunk (11.8%), lower limbs (11.8%), or upper limbs (9.1%).
Treatment & Methodology
Rhenium-SCT was administered as a single 50-Gy topical dose of rhenium-188 embedded in a resin applied via adhesive film to the lesion site. Efficacy was assessed using modified RECIST criteria, at 12 months follow-up. Quality of life was assessed using the Skin Cancer Index (SCI) at baseline, 6 months, and 12 months. Treatment comfort was assessed using a patient questionnaire, whilst patient- and clinician-evaluated cosmetic outcomes were determined using a visual analogue scale (VAS) grading of 0-10 (0 = very poor; 10 = no wound detectable). Safety was assessed via treatment-emergent adverse events (TEAEs) and CTCAE (Common Terminology Criteria for Adverse Events) grading.
Key 12-Month Results:
These findings confirm that Rhenium-SCT®, administered in a single session, delivers sustained high efficacy and improved quality of life, with excellent cosmetic outcomes and minimal adverse effects.
"Rhenium-SCT® has consistently demonstrated effectiveness and safety in prior studies," said Dr. Gerhard Dahlhoff, Medical Director at OncoBeta®. "This 12-month interim data further reinforces its value as a non-invasive, targeted treatment option for NMSC, particularly for patients seeking alternatives to surgery due to cosmetic or health-related concerns."
"The 12-month results from the EPIC-Skin Study represent a major milestone for OncoBeta®," added Shannon D. Brown III, CCO OncoBeta & Managing Director Europe. "These results support the efficacy, safety, and patient satisfaction associated with Rhenium-SCT®. These are the three foundational pillars of our patient-first vision, emphasising not only clinical outcomes, but also the patient experience in achieving them."
