In Novel Cohort, New Data Confirms DecisionDx®-SCC Provides Significant, Independent and Clinically Actionable Risk-Stratification of Patients, Including in Various High-Risk Subgroups
07 Marzo 2024 - 6:00AM
Business Wire
Largest study of gene expression profile
testing in patients with high-risk cutaneous squamous cell
carcinoma (SCC) supports test’s ability to provide clinically
actionable risk stratification to guide treatment decisions for
patients diagnosed with this impactful skin cancer
Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving
health through innovative tests that guide patient care, today
announced the publication of a new multi-center performance study
of its DecisionDx-SCC risk stratification test. The study,
published in Dermatology and Therapy and available here, analyzed
the independent performance of DecisionDx-SCC from risk factors and
traditional staging systems (i.e., Brigham and Women’s Hospital
(BWH) and American Joint Committee on Cancer Staging Manual 8th
Edition (AJCC8) staging), and demonstrated significantly improved
predictive accuracy when the test’s results were integrated with
the staging systems and National Comprehensive Cancer Network®
(NCCN) guidelines to guide risk-appropriate treatment pathway
decisions that can improve patient outcomes.
“Data-driven risk assessment is the foundation of sound clinical
decision-making,” said Ashley Wysong, M.D., M.S., lead study
author, professor, distinguished chair of dermatology and founding
chair of the department of dermatology at the University of
Nebraska Medical Center. “Incorporating DecisionDx-SCC test results
into the management of high-risk SCC can help ensure patients
receive the best care possible by incorporating their biological
risk of metastasis into the treatment plan. Use of the test in
clinical practice can help with optimization of healthcare
resources by reducing both overtreatment of patients with a low
biological risk of metastasis and undertreatment of patients with
aggressive tumor biology.”
The DecisionDx-SCC test was developed and validated to improve
the accuracy of metastatic risk prediction for patients with
high-risk SCC, classifying patients as low (Class 1), higher (Class
2A) or highest risk (Class 2B) of regional or distant metastasis
within three years based on the gene expression profile of their
tumor. The data in this study support use of the test’s results in
the clinical management of high-risk SCCs as they can provide
impactful risk-stratification to guide risk-appropriate treatment
pathway decisions, such as the use of nodal assessment (i.e.,
imaging) and adjuvant radiation therapy (ART).
The goal of this study was to present an independent validation
of the DecisionDx-SCC test in a novel performance cohort (n=534)
and then merge it with the test’s initial independent validation
cohort (n=420) to evaluate the performance of the test in providing
independent prognostic value to risk classification systems,
individual clinicopathologic risk factors and clinically relevant
patient populations.1-2 In the study, DecisionDx-SCC demonstrated
statistically significant risk-stratification of patients with
high-risk SCC (p<0.001); 3-year metastasis-free survival rates
were 94.1%, 81.1% and 56.8% for patients with Class 1, Class 2A and
Class 2B test results, respectively. The entire population had
3-year metastasis-free survival of 87.5%. DecisionDx-SCC also
provided significant and clinically actionable risk stratification
in various patient subgroups, including NCCN high and very
high-risk, lower-stage BWH tumors and Medicare-eligible patients,
further stratifying risk to help guide important treatment
decisions for these patients.
Generally, treatment pathways for patients with SCC are based on
population-based estimates of risk, informed by guidelines and
traditional staging systems (AJCC8 and BWH) which use various
clinicopathological risk factors to predict a patient’s risk of
metastasis. Multivariate analyses demonstrated that DecisionDx-SCC
Class 2A and 2B test results were independent and significant
predictors of metastasis when evaluated in the context of NCCN risk
stratification, AJCC8 and BWH staging, and various
clinicopathologic risk factors, such as immunosuppression, poor
differentiation and tumor thickness (>6mm) (p<0.001).
Importantly, integrating DecisionDx-SCC with individual
clinicopathologic risk factors or risk classification systems
(AJCC8 and BWH) significantly improved the accuracy for prediction
of metastatic events (ANOVA for model deviance, p<0.0001 for all
models). These data support the use of DecisionDx-SCC test results,
informed by a patient’s tumor biology, to guide personalized
patient treatment decisions aligned to a patient’s risk of
metastasis over three years. These decisions could include
risk-aligned reductions in treatment intensity for patients with
low risk (Class 1) test results and intensified treatment, such as
consideration of ART, for patients at a higher risk of experiencing
metastasis (Class 2A and 2B).
“Castle is committed to improving the care of patients with SCC
through broader use of our DecisionDx-SCC test,” said Matthew
Goldberg, M.D., board-certified dermatologist and
dermatopathologist, and senior vice president, medical, at Castle
Biosciences. “As such, we continue to develop evidence showing that
our test adds independent prognostic value to the clinical and
pathologic risk factors used for guiding risk-informed treatment
plans within current guidelines. The DecisionDx-SCC test result is
interpreted by the treating clinician in the context of what they
already know about their patient’s tumor to improve their
prognostic accuracy and inform more closely risk-aligned management
decisions with the goal of improving clinical outcomes for their
patients with high-risk skin cancer.”
About DecisionDx®-SCC
DecisionDx-SCC is a 40-gene expression profile test that uses an
individual patient’s tumor biology to predict individual risk of
cutaneous squamous cell carcinoma metastasis for patients with one
or more risk factors. The test result, in which patients are
stratified into a Class 1 (low), Class 2A (higher) or Class 2B
(highest) risk category, predicts individual metastatic risk to
inform risk-appropriate management. Peer-reviewed publications have
demonstrated that DecisionDx-SCC is an independent predictor of
metastatic risk and that integrating DecisionDx-SCC with current
prognostic methods can add positive predictive value to clinician
decisions regarding staging and management.
About Castle Biosciences
Castle Biosciences (Nasdaq: CSTL) is a leading diagnostics
company improving health through innovative tests that guide
patient care. The Company aims to transform disease management by
keeping people first: patients, clinicians, employees and
investors.
Castle’s current portfolio consists of tests for skin cancers,
Barrett’s esophagus, mental health conditions and uveal melanoma.
Additionally, the Company has active research and development
programs for tests in other diseases with high clinical need,
including its test in development to help guide systemic therapy
selection for patients with moderate-to-severe atopic dermatitis,
psoriasis and related conditions. To learn more, please visit
www.CastleBiosciences.com and connect with us on LinkedIn,
Facebook, X and Instagram.
DecisionDx-Melanoma, DecisionDx-CMSeq, DecisionDx-SCC, MyPath
Melanoma, DiffDx-Melanoma, TissueCypher, IDgenetix, DecisionDx-UM,
DecisionDx-PRAME and DecisionDx-UMSeq are trademarks of Castle
Biosciences, Inc.
Forward-Looking Statements
This press release contains forward-looking statements 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: the ability of DecisionDx-SCC to
(i) significantly improve predictive accuracy to guide
risk-appropriate treatment pathway decisions that can improve
patient outcomes and (ii) optimize healthcare resources in clinical
practice. The words “can,” “potential” 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: subsequent study or trial results
and findings may contradict earlier study or trial results and
findings or may not support the recommendations and guidelines
presented in this report, including with respect to the discussion
of DecisionDx-Melanoma in this press release; actual application of
our tests may not provide the aforementioned benefits to patients;
and the risks set forth under the heading “Risk Factors” in our
Annual Report on Form 10-K for the twelve months ended December 31,
2023, and in our other filings with the SEC. The forward-looking
statements are applicable only as of the date on which they are
made, and we do not assume any obligation to update any
forward-looking statements, except as may be required by law.
- Wysong A, Newman JG, Covington KR, et al. Validation of a
40-gene expression profile test to predict metastatic risk in
localized high-risk cutaneous squamous cell carcinoma. J Am Acad
Dermatol. 2021;84(2):361-369.
- Ibrahim SF, Kasprzak JM, Hall MA, et al. Enhanced metastatic
risk assessment in cutaneous squamous cell carcinoma with the
40-gene expression profile test. Future Oncol.
2022;18(7):833-847.
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Investor Contact: Camilla Zuckero
czuckero@castlebiosciences.com
Media Contact: Allison Marshall
amarshall@castlebiosciences.com
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