On May 19, 2016 Castle Biosciences, Inc., a provider of molecular diagnostics to improve cancer treatment decisions, reported new clinical data on DecisionDx-UM, its gene expression profile (GEP) test to predict metastasis in patients diagnosed with uveal melanoma (Press release, Castle Biosciences, MAY 19, 2016, View Source [SID:1234512612]). The new data will be highlighted in a presentation at the 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held in Chicago, IL from June 3-7.
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In a poster presentation titled, "A Prospective, Multi-Center Study to Evaluate the Performance and Clinical Utility of a 15-Gene Expression Profile for Uveal Melanoma" (Abstract #9575), Castle Biosciences researchers and collaborators will present findings from 70 patients in the prospective, multi-center CLEAR (Clinical Application of DecisionDx-UM Gene Expression Assay Results) study. The CLEAR study tracked clinical management and metastatic outcomes of patients with low-risk Class 1 or high-risk Class 2 gene test results who had no evidence of distant metastasis at the time of primary tumor treatment. Surveillance mode and frequency were independently determined by participating physicians as they deemed appropriate for low-risk Class 1 and high-risk Class 2 patients.
Study Results
37 patients (53%) had a low-risk Class 1 GEP test result; 33 patients (47%) had a high-risk Class 2 result;
Impact on clinical management:
All Class 2 patients were managed with high intensity surveillance (imaging and/or liver function tests every 3-6 months);
81% of Class 1 patients were managed with low intensity surveillance (imaging and/or liver function tests every year);
There was a significant difference in management of Class 1 and Class 2 patients (p=2.1×10-13);
33% of Class 2 patients were referred to a medical oncologist for surveillance and/or clinical trial enrollment, compared to 11% of Class 1 patients (p=0.04).
Clinical outcomes:
Overall, two Class 1 patients and 12 Class 2 patients developed metastasis (p=0.002) with a median follow-up of 27.3 months;
At 3 years, metastasis-free survival rates were 100% for Class 1 and 63% for Class 2 (p=0.003).
"This prospective study demonstrated clinically and statistically significant impact on follow-up treatment consistent with a previously published retrospective multi-center clinical utility study," commented Derek Maetzold, President and CEO of Castle Biosciences. "In addition, the clinical performance of the test is consistent with previously published prospective multi-center and single-center studies, confirming the robustness of the DecisionDx-UM test."
About Uveal Melanoma
Uveal melanoma, while rare, is the most common form of eye cancer in the United States with about 1,600 diagnoses per year. This form of eye cancer may occur in any of the three parts of the uvea. Similar to other melanomas, uveal melanoma begins in cells called melanocytes that help produce the pigments of the skin, hair and eyes. While more common in patients who are middle-aged with fair skin, uveal melanoma can affect people of all complexions and ages.
Although a small percentage (3%) of patients with uveal melanoma have detectable metastatic lesions at the time of diagnosis or treatment of the primary tumor, up to 50% of patients will subsequently develop metastatic disease. This necessitates a rigorously validated, accurate and reliable tool to identify patients likely to develop distant metastasis.
About DecisionDx-UM
The DecisionDx-UM test measures the gene expression profile (GEP), or molecular signature, of an individual’s tumor and identifies with high accuracy the likelihood of metastasis.
The DecisionDx-UM test is standard of care in the management of uveal melanoma in the majority of ocular oncology practices. It is the only test for uveal melanoma that has achieved National Cancer Institute/National Comprehensive Cancer Network Level of Evidence 1A, a critical factor in test adoption and clinical decision-making. Additionally, the American Joint Committee on Cancer recommends gene expression profile testing for use as the results are "clinically significant." The American Joint Committee on Cancer (AJCC, version 7, 2010) is the only national organization that reviews uveal melanoma and the DecisionDx-UM test is the only clinically available GEP test for use in the U.S. The test has been validated in multiple prospective and retrospective studies. More information about the test and disease can be found at www.MyUvealMelanoma.com.