Dr. Polsky on Validating ctDNA as a Biomarker in BRAF-Mutant Melanoma

David Polsky, MD, PhD
Published: Monday, Sep 09, 2019



David Polsky, MD, PhD, Alfred W. Kopf, MD Professor of Dermatologic Oncology, Ronald O. Perelman Department of Dermatology, professor, Department of Pathology, and director, Pigmented Lesion Service, NYU Langone’s Perlmutter Cancer Center, discusses the next steps that have to be taken to validate the clinical utility of circulating tumor DNA (ctDNA) as a biomarker in BRAF-mutant melanoma. 

A study led by Polsky demonstrated the clinical validity of ctDNA monitoring in predicting whether patients with advanced BRAF-mutant melanoma would benefit from either dabrafenib (Tafinlar) alone or in combination with trametinib (Mekinist). Investigators need to evaluate additional timepoints as they only had week 4 samples for the first analysis. Further analysis could show better predictive value on which to base a survival model, says Polsky.  

If additional follow-up reveals consistent findings, investigators would like to launch a clinical trial randomizing patients to a prespecified second-line therapy. At the time of progression, patients would switch to another agent and then could be randomized to receive therapy based on a rise in their ctDNA versus radiographic progression, which is the standard of care. That type of a design would demonstrate whether the marker has clinical utility, not just clinical validity, concludes Polsky.
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David Polsky, MD, PhD, Alfred W. Kopf, MD Professor of Dermatologic Oncology, Ronald O. Perelman Department of Dermatology, professor, Department of Pathology, and director, Pigmented Lesion Service, NYU Langone’s Perlmutter Cancer Center, discusses the next steps that have to be taken to validate the clinical utility of circulating tumor DNA (ctDNA) as a biomarker in BRAF-mutant melanoma. 

A study led by Polsky demonstrated the clinical validity of ctDNA monitoring in predicting whether patients with advanced BRAF-mutant melanoma would benefit from either dabrafenib (Tafinlar) alone or in combination with trametinib (Mekinist). Investigators need to evaluate additional timepoints as they only had week 4 samples for the first analysis. Further analysis could show better predictive value on which to base a survival model, says Polsky.  

If additional follow-up reveals consistent findings, investigators would like to launch a clinical trial randomizing patients to a prespecified second-line therapy. At the time of progression, patients would switch to another agent and then could be randomized to receive therapy based on a rise in their ctDNA versus radiographic progression, which is the standard of care. That type of a design would demonstrate whether the marker has clinical utility, not just clinical validity, concludes Polsky.



View Conference Coverage
Online CME Activities
TitleExpiration DateCME Credits
Advances in™ Melanoma: Exploring BRAF/MEK in Adjuvant and Neoadjuvant SettingsSep 28, 20191.5
Medical Crossfire®: What Does Data Tell Us About How to Optimize Checkpoint Inhibitor Strategies Across Lines of Care for Patients with Melanoma?Nov 30, 20191.5
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