Data Demonstrating DecisionDx®-Melanoma Was a Significant, Independent Predictor of Metastatic Recurrence in Stage I-III Cutaneous Melanoma Published in Future Oncology
Castle Biosciences (NASDAQ:CSTL) announced a study showcasing its DecisionDx-Melanoma test's predictive capabilities in cutaneous melanoma. The study, involving 438 patients, revealed that those classified as Class 1A (low risk) achieved a remarkable five-year recurrence-free survival rate of 95.8% and a distant metastasis-free survival rate of 99.2%. This underscores the test's role in aiding personalized treatment decisions and improving patient outcomes, with significant independent predictive value over traditional staging methods.
- DecisionDx-Melanoma test shows high predictive accuracy for melanoma prognosis.
- Class 1A patients have a 95.8% five-year recurrence-free survival rate.
- The study supports DecisionDx-Melanoma as an independent predictor of metastatic recurrence.
- None.
Data demonstrated that patients with a DecisionDx-Melanoma Class 1A (low risk) test result had a five-year recurrence-free survival rate and distant metastasis-free survival rate of
DecisionDx-Melanoma is Castle’s gene expression profile (GEP) test that uses an individual patient’s tumor biology to predict the risk of cutaneous melanoma metastasis or recurrence, as well as the risk of sentinel lymph node (SLN) positivity, independent of traditional staging factors. The study, titled “The 31-gene expression profile stratifies recurrence and metastasis risk in patients with cutaneous melanoma,” analyzed 438 patients who were tested with DecisionDx-Melanoma as part of their clinical care. The study can be accessed here.
“This study reinforced one of the primary reasons why I order DecisionDx-Melanoma for my patients as soon as they receive a melanoma diagnosis,” said first author
Study background and highlights:
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The study’s primary purpose was to show risk stratification by DecisionDx-Melanoma in patients with stage I–III cutaneous melanoma. A secondary end point was to demonstrate the added prognostic value of DecisionDx-Melanoma when combined with complete
American Joint Committee on Cancer (AJCC) staging (including SLN status) or with SLN status alone, for recurrence detection. - 438 patients with stage I–III melanoma consecutively tested with DecisionDx-Melanoma were analyzed and stratified as low risk (Class 1A), intermediate risk (Class 1B/2A) or high risk (Class 2B) of recurrence or metastasis.
- DecisionDx-Melanoma significantly stratified five-year melanoma survival prognoses for patients, including recurrence-free survival (RFS) (p<0.001), distant metastasis-free survival (DMFS) (p<0.001) and melanoma-specific survival (MSS) (p<0.001).
- Patients with a DecisionDx-Melanoma low-risk result (Class 1A) had higher five-year survival outcomes and were less likely to experience a recurrence than patients with a high-risk result (Class 2B).
- Multivariable analysis showed that DecisionDx-Melanoma is a significant, independent predictor of metastatic recurrence (hazard ratio=5.38, p=0.014).
- DecisionDx-Melanoma increased prognostic survival accuracy over sentinel lymph node status alone.
- Consistent with previous validation and performance studies, the study demonstrated that DecisionDx-Melanoma added independent prognostic value to current staging guidelines for cutaneous melanoma to identify patients with a high and low recurrence or metastasis risk to improve patient management.
About DecisionDx-Melanoma
DecisionDx®-Melanoma is a gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous melanoma metastasis or recurrence, as well as sentinel lymph node positivity, independent of traditional staging factors, and has been studied in more than 5,700 patient samples. Using tissue from the primary melanoma, the test measures the expression of 31 genes. The test has been validated in four archival risk of recurrence studies of 901 patients and six prospective risk of recurrence studies including more than 1,600 patients. Impact on patient management plans for one of every two patients tested has been demonstrated in four multicenter and single-center studies including more than 560 patients. The consistent performance and accuracy demonstrated in these studies provides confidence in disease management plans that incorporate DecisionDx-Melanoma test results. To predict risk of recurrence and likelihood of sentinel lymph node positivity, the Company utilizes its proprietary algorithms, i31-ROR and i31-SLNB, to produce an Integrated Test Result. Through
More information about the test and disease can be found at www.CastleTestInfo.com.
About
Castle also has active research and development programs for tests in other dermatologic diseases with high clinical need, including its test in development to predict systemic therapy response in patients with moderate to severe psoriasis, atopic dermatitis and related conditions.
For more information, visit www.CastleBiosciences.com.
DecisionDx-Melanoma, DecisionDx-CMSeq, DecisionDx-SCC, myPath Melanoma, DecisionDx DiffDx-Melanoma, DecisionDx-UM, DecisionDx-PRAME and DecisionDx-UMSeq are trademarks of
Forward-Looking Statements
The information in this press release contains forward-looking statements and information within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the “safe harbor” created by those sections. These forward-looking statements include, but are not limited to, statements concerning DecisionDx-Melanoma’s ability to predict the risk of cutaneous melanoma metastasis or recurrence, as well as the risk of SLN positivity, independent of traditional staging factors, be a significant independent predictor of metastatic recurrence, provide personalized, prognostic information that helps determine the likelihood that the cancer will spread, and inform decisions for treatment to ensure the best possible outcome for each patient’s disease. The words “anticipates,” “believes,” “estimates,” “expects,” “intends,” “may,” “plans,” “projects,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that we make. These forward-looking statements involve risks and uncertainties that could cause our actual results to differ materially from those in the forward-looking statements, including, without limitation, the effects of the COVID-19 pandemic on our business and our efforts to address its impact on our business, subsequent study results and findings that contradict earlier study results and findings, DecisionDx-Melanoma’s ability to provide the aforementioned benefits to patients and the risks set forth in our Quarterly Report on Form 10-Q for the quarter ended
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