Study results, which include 5,651 patients in
the National Cancer Institute’s Surveillance, Epidemiology and End
Results (SEER) Program Registries, support the use of
DecisionDx-Melanoma in stage I melanoma to help inform clinical
decision-making
Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving
health through innovative tests that guide patient care, today
announced the publication of a study in Cancers1 demonstrating that
DecisionDx-Melanoma provided significantly better risk
stratification than American Joint Committee on Cancer 8th Edition
(AJCC8) staging in patients with stage I cutaneous melanoma (CM).
This study reports the results of two large stage I cohorts,
including 5,651 patients from the National Cancer Institute’s SEER
Program Registries (analyzing survival) and 1,261 patients from a
combined cohort (analyzing recurrence and survival), and suggests
that incorporating the DecisionDx-Melanoma test into clinical
practice may help clinicians and patients obtain more precise
information about a patient’s prognosis to inform more
personalized, risk-aligned treatment and surveillance management
plans.
“Relying on staging alone to determine a melanoma patient’s
prognosis misses patients with aggressive tumor biology who may be
at higher risk of recurrence, metastasis or death from their
disease,” said Sebastian Podlipnik, M.D., Ph.D., lead study author
and dermatologist at the Hospital Clínic de Barcelona, Universitat
de Barcelona, in Spain. “As supported by the data in this study,
incorporating DecisionDx-Melanoma test results into clinical
decision-making can help identify which patients with lower stage
tumors may be at higher risk of disease progression and could
benefit from more aggressive follow-up schedules and treatment
plans to identify recurrence earlier when it has generally been
shown to have better treatment outcomes.”
Traditionally, treatment pathways for CM have been based upon
clinicopathologic AJCC8 staging, which provides population-based
risk of progression estimates. Stage I CM tumors are considered low
risk; however, since stage I encompasses a large group of patients
diagnosed, many melanoma-specific deaths are seen in patients
initially diagnosed with stage I disease. Thus, there is a clinical
gap in the low-risk treatment pathway for stage I patients.
DecisionDx-Melanoma was developed and validated to provide a
tumor-specific risk of recurrence, independent of the current risk
factors used in AJCC8 staging, specifically tumor thickness and
ulceration. The test classifies patients as having a low risk
(Class 1A), intermediate risk (Class 1B/2A) or high risk (Class 2B)
of tumor recurrence, metastasis and melanoma-specific mortality
based on the patient’s tumor biology. As a result of this
risk-stratification information, DecisionDx-Melanoma is used
clinically to help inform patient-specific treatment pathway
decisions.
The new study in Cancers provides further information that
DecisionDx-Melanoma testing could enable more precise risk
stratification in stage I melanomas than provided by traditional
staging to better inform risk-appropriate clinical management. This
multi-center study analyzed data from nearly 7,000 patients with
stage I CM to assess their five-year recurrence-free survival (RFS)
and melanoma-specific survival (MSS) using the DecisionDx-Melanoma
test. There were two cohorts of patients: a pooled cohort from
previous studies (combined cohort, n=1,261) and a second, large,
real-world cohort of unselected patients who received the
DecisionDx-Melanoma test as part of their clinical care (patients
diagnosed with CM between 2013–2018 who were linked to outcomes
data from the National Cancer Institute’s SEER Program registries,
n=5,651). The combined cohort was evaluated for RFS and MSS, and
the SEER cohort was evaluated for MSS.
In both cohorts, DecisionDx-Melanoma provided greater separation
between patients with high- and low-risk test results than seen
between AJCC8 stage IA and IB, demonstrating the ability of the
test to provide improved risk stratification over staging.
Combined cohort
Separation of risk
RFS stratification
DecisionDx-Melanoma test
results
Class 1A (low risk) (97.3%) vs. Class 2B
(high risk) (77.3%); p < 0.001
AJCC8 staging
Stage IA (97.5%) vs. IB (89.3%); p <
0.001
SEER cohort
Separation of risk
MSS
stratification
DecisionDx-Melanoma test
results
Class 1A (low risk) (98.0%) vs. Class 2B
(high risk) (92.3%); p < 0.001
AJCC8 staging
Stage IA (97.6%) vs. stage IB (97.9%); p
< 0.001
In the combined cohort, multivariable analysis showed that a
DecisionDx-Melanoma Class 2B test result was the strongest
predictor of recurrence in stage I CM (HR = 5.16, p < 0.001);
similarly, in the SEER cohort, multivariable analysis indicated
that a high-risk test result was the only significant predictor of
melanoma-specific mortality in stage I patients (HR = 9.23, p <
0.001).
The data in this study support the use of DecisionDx-Melanoma to
help guide improved, risk-aligned care in patients considered low
risk by staging (i.e., patients with stage I CM tumors) but who
have aggressive molecular tumor biology and may be missed using
only staging criteria for prognosis.
About DecisionDx®-Melanoma
DecisionDx-Melanoma is a gene expression profile risk
stratification test. It is designed to inform two clinical
questions in the management of cutaneous melanoma: a patient’s
individual risk of sentinel lymph node (SLN) positivity and a
patient's personal risk of melanoma recurrence and/or metastasis.
By integrating tumor biology with clinical and pathologic factors
using a validated proprietary algorithm, DecisionDx-Melanoma is
designed to provide a comprehensive and clinically actionable
result to guide risk-aligned patient care. DecisionDx-Melanoma has
been shown to be associated with improved patient survival and has
been studied in more than 10,000 patient samples.
DecisionDx-Melanoma’s clinical value is supported by 50
peer-reviewed and published studies, providing confidence in
disease management plans that incorporate the test’s results.
Through Sept. 30, 2023, DecisionDx-Melanoma has been ordered more
than 146,000 times for patients diagnosed with cutaneous
melanoma.
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, 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-Melanoma to (i) provide significantly better risk
stratification than AJCC8 staging in patients with stage I CM and
(ii) help clinicians and patients obtain more precise information
about a patient’s risk of disease progression to inform more
personalized, risk-aligned treatment and surveillance management
plans. The words “believe,” “can,” “potential,” “will” 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
results obtained in this study, 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 Quarterly Report on Form 10-Q for the quarter
ended Sept. 30, 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.
- Podlipnik S, Martin BJ, Morgan-Linnell SK et al. The 31-gene
expression profile test outperforms AJCC in stratifying risk of
recurrence in patients with stage I cutaneous melanoma. Cancers.
2024;16(2):287. https://doi.org/10.3390/cancers16020287
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version on businesswire.com: https://www.businesswire.com/news/home/20240226075754/en/
Investor Contact: Camilla Zuckero
czuckero@castlebiosciences.com
Media Contact: Allison Marshall
amarshall@castlebiosciences.com
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