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. 2025 May 2:220:115372.
doi: 10.1016/j.ejca.2025.115372. Epub 2025 Apr 4.

Risk stratification using the Merlin Assay (CP-GEP) in an independent cohort of 930 patients with clinical stage I/II melanoma who did not undergo sentinel lymph node biopsy

Teresa Amaral  1 , Eftychia Chatziioannou  2 , Alica Nuebling  2 , Lena Nanz  2 , Tobias Sinnberg  2 , Heike Niessner  3 , Tim Arentsen  4 , Romy Ruiter  4 , Jvalini Dwarkasing  4 , Alexander M Eggermont  5 , Ulrike Leiter  3 , Lukas Flatz  3 , Stephan Forchhammer  2
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Free article

Risk stratification using the Merlin Assay (CP-GEP) in an independent cohort of 930 patients with clinical stage I/II melanoma who did not undergo sentinel lymph node biopsy

Teresa Amaral et al. Eur J Cancer. .
Free article

Abstract

Purpose: More than 80 % of patients with melanoma are diagnosed without nodal metastasis, but most of those who relapse or die from melanoma are initially diagnosed as low risk early-stage. Here we investigate the ability of the Merlin Assay to stratify patients who did not undergo sentinel lymph node biopsy (SLNB) for their risk of recurrence.

Patients and methods: 930 patients with clinical stage I/II primary cutaneous melanoma from the University of Tuebingen diagnosed between 2000 and 2020 were analyzed. None of the patients included underwent SLNB. The Merlin Assay combines patient age at diagnosis, Breslow thickness, and gene expression of eight specific genes from the primary tumor. Risk output labels are High Risk and Low Risk.

Results: Clinicopathological gene expression profile (CP-GEP) identified 879 patients as Low Risk and 51 patients as High Risk. The 10-year RFS (HR 20.07; p < 0.001) and DMFS (HR 19.39; p < 0.001) were significantly higher in CP-GEP Low Risk versus High Risk patients. Similar results were observed in 10-year MSS (HR 35.85; p < 0.001). CP-GEP analysis of lentigo maligna melanoma and acral lentiginous melanoma showed that the performance of assay was independent of melanoma histological subtypes.

Conclusion: This study shows that CP-GEP has the potential to stratify patients with early-stage melanoma who did not undergo SLNB based on their risk of recurrence. Patients with CP-GEP Low Risk have a significantly better long-term survival. CP-GEP shows to be promising for guiding SLNB referral and may support melanoma care by optimizing personalized treatment plans and potential surveillance regimens.

Keywords: CP-GEP; Cutaneous melanoma; Gene expression profile; Melanoma specific survival; Personalized therapy; Prognostic factors; Relapse-free survival; SLNB; Stage I/II.

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Conflict of interest statement

Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: TA reports personal fees for advisory board membership from Delcath and Philogen; personal fees as an invited speaker from Bristol Myers Squibb (BMS), Medscape, Neracare, Novartis and Pierre Fabre; personal fees for a writing engagement from CeCaVa and Medtrix; institutional fees as local principal investigator (PI) from Agenus Inc., AstraZeneca, BioNTech, BMS, HUYA Bioscience, Immunocore, IO Biotech, MSD, Pfizer, Philogen, Regeneron, Roche and University Hospital Essen; institutional fees as coordinating PI from Unicancer; institutional research grants from iFIT and Novartis; institutional funding from MNI - Naturwissenschaftliches und Medizinisches Institut, Neracare, Novartis, Pascoe, Sanofi and Skyline-Dx; non-remunerated membership of the American Society of Clinical Oncology (ASCO) and the Portuguese Society for Medical Oncology; a role as clinical expert in the area of medical oncology for Infarmed, and a role as an expert for SGA-Oncology at EMA. EC: No relationships to disclose. AL: No relationships to disclose. LN: No relationships to disclose. TS: reports institutional funding from Novartis and Pierre-Fabre outside the submitted work. HN: reports institutional funding from Novartis and Pierre-Fabre outside the submitted work. TA: reports stock and other ownership interests – SkylineDx B.V., Employment – SkylineDx B.V. RR: reports stock and other ownership interests – SkylineDx B.V., Employment – SkylineDx B.V. JD: reports stock and other ownership interests – SkylineDx B.V., Employment – SkylineDx B.V.; Leadership – SkylineDx B.V. and Honoraria – SciBase A.B. AE: reports stock and other ownership interests - IO Biotech, Sairopa B.V., SkylineDx B.V.; Honoraria Consulting or Scientific Advisory Role - Agenus, Boehringer Ingelheim GmbH, BioInvent, BioNTech, Brenus, CatalYm GmbH, Egle, Eurobio, ImmTech, IO Biotech, IQVIA, Merck KgA, Merck&Co, MSD, Oncolytics, Pierre Fabre, Sairopa BV, Secarna GmbH, SkylineDx B.V., Thermosome GmbH, Trained Immunity Therapeutics Discovery; Data safety monitoring board: BioNTech, IQVIA, Pfizer. UL: reports research support from MSD, consulting fees and honoraria from Sun Pharma, Sanofi (personal and institutional), MSD (personal and institutional), Novartis, Roche, Almirall Hermal, support for attending meeting from Sun Pharma and participation on a Data Safety Monitoring Board or Advisory Board from Sun Pharma, Sanofi, MSD, Novartis, Roche, Almirall Hermal, outside the submitted work. LF: reports Grants or contracts from Hookipa Pharma, SAKK / Immunophotonics, DFG Grant (Deutsche Forschungsgemeinschaft), Philogen and Mundipharma; consulting fees from Philogen, Sanofi, Novartis, BMS; participation on Data Safety Board University of Basel and stocks or stock options from Hookipa Pharma, outside the submitted work. SF: reports institutional funding from SkylineDx B.V. in relation with the submitted work; institutional grants from BioNTech and Neracare as well as personal honoraria for lectures from Recordati, Kyowa Kirin and Stemline Pharmaceutical, outside the submitted work.

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