SkylineDx Data Confirms Accuracy of the Merlin Test for Low- and High-Risk Melanoma

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SkylineDx, an oncology biotechnology company, announced new data from the MERLIN__001 trial, confirming the validity and efficacy of the Merlin test in identifying sentinel lymph node biopsy (SLNB) status in patients with melanoma.¹

The prospective US multi-center trial is the largest ever conducted to assess the performance of a genomic test for melanoma.² The first results from the study were presented at the 2024 Society for Melanoma Research Congress from October 10 to 13 in New Orleans, Louisiana.

The trial was performed at 9 academic sites in the US. It included 1686 patients with melanoma (T1-T3) who underwent SLNB. Patients were classified as “High Risk” or “Low Risk.” Overall, 37% of participants were in the low-risk category. Among these, only 7.1% had a positive SLN. This resulted in a negative predictive value of 92.9%. Conversely, 23.8% of patients deemed “High Risk” patients had positive SLNs.

The study also took a closer look at T1a, with the goal of avoiding overtreatment for early-stage melanoma. Patients with low-risk T1 melanoma (88%) had a post-test SLN positivity rate of only 1.5%. In contrast, 12% of patients were classified as high-risk with a higher SLN positivity rate of 15.8%.

Several patients with adverse features were also tested, including patients under age 40, those with lymph vascular invasion, and those with a high mitotic rate. These 37 patients were categorized in the low-risk group, with a post-test SLN positivity rate of 0%. Additionally, 7 patients without any adverse features were identified as high-risk (SLN positivity rate of 14.3%).

"The intent is to help prevent undertreatment in seemingly low-risk early-stage melanoma patients who are actually at risk for nodal metastasis,” Alexander Meves, MD, MBA, dermatologist at Mayo Clinic and principal inventor of the CP-GEP model, shared in a statement. “By accurately identifying these at-risk individuals, we ensure that they receive the necessary interventions, even in the absence of traditional clinical risk factors."³

The CP-GEP (clinical pathologic and gene expression profiling) Merlin model was developed by Mayo Clinic and SkylineDx BV and has already been launched in the US and Europe. Validated with an overall sentinel lymph node positivity rate of over 17%, CP-GEP is an accurate, non-invasive procedure that categorizes patients with melanoma as being at high or low risk for metastasis. The results can guide clinicians in choosing the most appropriate actions for prevention, screening, and SLNB treatment.

SLNB is a common procedure often recommended for patients with a predicted metastasis risk of >10%. However, because more than 80% of these procedures reveal no metastasis, patients experience increased risk of complications and costs, without realizing therapeutic benefit. The Merlin test allows surgeons to explore less aggressive treatment plans and improve overall patient care.

Vernon Sondak, MD, chair of the Department of Cutaneous Oncology at Moffitt Cancer Center and 1 of 3 principal investigators for this study, noted the results were significant for patient care.

"This landmark trial will allow us to have more informed conversations with our patients about their surgical treatment options,” Sondak said in a press statement. “These results provide critical insights for clinicians, allowing us to move toward more precise and individualized care."²

[Editor's note courtesy of Aaron Farberg, MD, as of 10/30/24: The CP-GEP Merlin Test test was designed to predict patients with less than a 5% risk of a positive sentinel lymph node. That 5% is the current standard of care by NCCN guidelines. The study was designed with the hypothesis that the test could predict patients with less than 5% positivity. Their outcome was that the test predicts patients with 7% risk, which makes it inadequate compared to our current standard of care.]

References

1. Hieken TJ, Egger ME, Angeles CV, et al. MERLIN_001: A prospective registry study of a primary melanoma gene-signature to predict sentinel node (SN) status and determine its prognostic value for more accurate staging of patients with sn-negative melanoma. Journal of Clinical Oncology. 2022;40(16_suppl). doi:10.1200/jco.2022.40.16_suppl.tps9606

2. SkylineDx Announces Data from Largest Prospective Multi-Center Melanoma Gene Expression Profiling Trial at 21st International Congress of the Society for Melanoma Research. SkylineDx. Published October 13, 2024. https://www.prnewswire.com/news-releases/skylinedx-announces-data-from-largest-prospective-multi-center-melanoma-gene-expression-profiling-trial-at-21st-international-congress-of-the-society-for-melanoma-research-302274550.html

3. SkylineDx Announces Presentation of New Data Highlighting the Predictive Power of the CP-GEP Merlin Test for T1a Cutaneous Melanoma Patients at the 21st International Congress of the Society for Melanoma Research. SkylineDx. Published October 11, 2024. https://www.prnewswire.com/news-releases/skylinedx-announces-presentation-of-new-data-highlighting-the-predictive-power-of-the-cp-gep-merlin-test-for-t1a-cutaneous-melanoma-patients-at-the-21st-international-congress-of-the-society-for-melanoma-research-302273871.html