October 29, 2019

Vanderbilt Oncologists Publish Results of First Study to Demonstrate Clinical Utility of Resolution Liquid Biopsy Assay to Monitor Response and Resistance to Ensartinib

New Journal of Thoracic Oncology publication concludes prospective application of technology may translate to improved outcomes for non-small cell lung cancer patients

— Vanderbilt-Ingram Cancer Center and Resolution Bioscience, Inc., today announced the first peer-reviewed scientific publication to track clinical response and resistance mechanisms to ensartinib using circulating tumor DNA (ctDNA). The peer-reviewed manuscript, “Monitoring therapeutic response and resistance: analysis of circulating tumor DNA in patients with ALK+ lung cancer,” was released online ahead of print publication in the Journal of Thoracic Oncology.

A team of scientists led by lung cancer researchers and clinicians at Vanderbilt-Ingram Cancer Center used the Resolution ctDx-Lung™ assay to identify actionable genomic alterations, as well as to monitor response and development of resistance to ensartinib, a second-generation ALK tyrosine kinase inhibitor (TKI). Pre-treatment plasma was collected from 76 patients with ALK+ non-small cell lung cancer (NSCLC) who were either ALK TKI naïve or had received prior ALK TKI. These plasma samples were analyzed for specific genetic alterations, and the results were correlated to tumor responses. In a subset of patients, serial changes in ALK alterations were also observed during ensartinib therapy.

“This is the first study to highlight treatment response and resistance mechanisms to ensartinib in patients who received this therapy,” said Leora Horn, MD, MS, Ingram Associate Professor of Cancer Research at Vanderbilt-Ingram Cancer Center and first author of the publication. “While further evaluation is required, these data suggest that longitudinal monitoring of genetic biomarkers that are associated with acquired resistance is feasible.”

“In the future, application of ctDNA technology could allow a physician to prescribe a more effective and personalized treatment to improve clinical outcomes before the cancer progresses,” said Christine M. Lovly, MD, PhD, Associate Professor of Medicine at Vanderbilt-Ingram Cancer Center and senior author of the publication.

As part of the study, the team of scientists also analyzed the concordance between the Resolution ctDx-Lung assay and paired tumor tissue, as well as the association of total detected ctDNA with progression-free survival. Overall, there was a high degree (91%) of fusion concordance between plasma and tissue next-generation sequencing analyses. The same Resolution liquid biopsy assay was also recently used by researchers at Dana-Farber Cancer Institute to detect nearly twice as many actionable gene fusion mutations with significantly higher allele frequencies than another commercially available ctDNA test.

“The Resolution ctDx-Lung assay is designed to provide a fast, accurate, and non-invasive solution for mutationally comprehensive tumor genotyping,” said Mark Li, CEO of Resolution Bioscience. “This new publication adds to the growing body of evidence demonstrating the clinical utility of our liquid biopsy approach and its ability to inform NSCLC disease evolution and response to therapy.”

To view the full manuscript, please visit https://doi.org/10.1016/j.jtho.2019.08.003.

About Vanderbilt-Ingram Cancer Center
About Vanderbilt-Ingram Cancer Center Vanderbilt-Ingram Cancer Center provides compassionate care, evidence-based prevention, pioneering research, community engagement, and survivorship support. Designated a Comprehensive Cancer Center by the National Cancer Institute and a member of the National Comprehensive Cancer Network, Vanderbilt-Ingram is at the forefront of discovery. Its teams of scientists and clinicians are defining personalized care with immunotherapies, targeted treatments, precision radiation-oncology, innovative surgeries and novel imaging technologies. For more information, visit www.vicc.org.

About Resolution Bioscience
Resolution Bioscience is a privately held company dedicated to developing a highly sensitive, non-invasive liquid biopsy platform that improves cancer diagnostics and monitoring for patients around the world. The company has developed and patented core technology for circulating cell-free DNA NGS analysis and was the first to demonstrate identification of all four major types of mutations in a blinded, clinical study. The company is based in Kirkland, WA. For more information, visit www.resolutionbio.com

Resolution Bioscience, the Resolution Bioscience logo, and Resolution HRD are trademarks of Resolution Bioscience, Inc. All other brands may be trademarks of their respective holders.