Prognostic Model Reveals High-risk Melanoma Patients that need a Clinical Trial

ROTTERDAM, Netherlands and SAN DIEGO, May 14, 2020 /PRNewswire/ -- SkylineDx announces the publication of two ASCO abstracts describing a biomarker that identifies a subgroup of skin cancer (cutaneous melanoma) patients that could benefit from adjuvant therapy as their melanoma is at high risk of recurrence, but who are currently not diagnosed as high risk because they do not have metastasis in their sentinel lymph nodes. At present only melanoma patients that have detected metastasis in their lymph nodes (clinical stage III) are referred for adjuvant therapy. In a US cohort totaling 837 patients, 637 (76%) patients had no nodal metastasis in which the biomarker (named the CP-GEP model) was able to identify 327 (51%) patients at high-risk of melanoma recurrence within 5 years. This group has a similar prognosis as the treatment eligible stage III patients ^[3].

Clinical trials on adjuvant treatment are moving towards the inclusion of non-metastatic stage IIB and IIC patients. Nonetheless, a stage-specific optimization of the CP-GEP model identified an additional 45% of stage IIA patients in the above-mentioned cohort, currently excluded from trials, with a demonstrated worse prognosis than stage IIC and IIIA patients. These patients should be considered for inclusion into a trial to investigate if treatment with adjuvant systemic therapy can prevent their melanoma from returning ^[4]. The optimized CP-GEP model for this prognostic utility will be further researched under the Peregrine Study Initiative in the Falcon R&D Program.

Melanoma specialist, Dr. Alexander Eggermont, Chief Scientific Officer of the Princess Máxima Center in the Netherlands, says: "Over the last years significant progress has been made in advancing adjuvant treatments for metastatic stage III melanoma patients. However, large population-based studies demonstrate that approximately 50% of melanoma-related deaths occur in patients that were originally diagnosed with non-metastatic disease. The discovery of the prognostic CP-GEP model to select high-risk Stage IIA patients for adjuvant therapy is a significant breakthrough that can potentially benefit thousands of patients annually."

"One of our core value statements is to think about how our innovation can impact many lives", comments Dharminder Chahal, CEO SkylineDx. "It is confronting to see the potential undertreatment in these skin cancer patients. Some are going home, partially reassured of not having metastasis, only to find out later that the melanoma has returned relatively fast. There should be a research focus on the improvement we could achieve in defining personalized treatment pathways on the basis of individual risk."

About CP-GEP

The CP-GEP model calculates the risk of melanoma returning on an individual basis through a combination analysis of 8 genes from the patient's primary tumor, the tumor thickness and the patient's age. The model has been previously published in JCO Precision Oncology ^[2].The prognostic use of the CP-GEP model is the main focus of the Peregrine Study Initiative, developed under the wings of the Falcon R&D Program. More information on www.falconprogram.com.

About SkylineDx

SkylineDx is a high-tech commercial-stage biotech company headquartered in Rotterdam, the Netherlands and a commercial office and CAP/CLIA certified laboratory in San Diego, California, USA. The company uses its expertise to bridge the gap between academically discovered gene expression signatures and commercially available diagnostic products with high clinical utility. With the focus on diagnostics, SkylineDx assists healthcare professionals in accurately determining the type or status of the disease or to predict a patient's response to a specific treatment. Based on the test results, healthcare professionals can tailor the treatment to the individual patient. To learn more, please visit www.skylinedx.com.

Footnotes

¹ Link to this press release on website SkylineDx (click here)

² Bellomo et al., 2020. Model combining tumor molecular and clinicopathologic risk factors predicts sentinel lymph node metastases in primary cutaneous melanoma. JCO Precis Oncol 4:319-334 (click here)

³ Eggermont et al., 2020. Using a clinicopathologic and gene expression model to identify melanoma patients at high risk for disease relapse. Online poster presentations are scheduled for May 29^th at 2PM CEST. Link to ASCO abstract.

⁴ Wever et al., 2020. Identification of stage IIA melanoma patients at high risk for disease relapse using a clinicopathologic and gene expression model. Link to ASCO abstract.