New Publication Shows DecisionDx®-SCC Identifies High-Risk Squamous Cell Carcinoma Patients Who Are Likely to Benefit from Adjuvant Radiation Therapy and Those Who Can Consider Deferring Treatment Based on Biological Risk of Metastasis
29 Mayo 2024 - 3:30PM
Business Wire
In the study, patients with DecisionDx-SCC
Class 2B test results, predicted to have the highest risk of
metastasis by the test, who were treated with adjuvant radiation
therapy (ART) had 50% higher metastasis-free survival (MFS) rates,
on average, and slowed disease progression compared to Class 2B
patients who did not receive ART
Patients with Class 1 test results, predicted
to have a lower risk of metastasis, did not see an improvement in
survival after receiving ART, which together indicates these
patients may be able to avoid the treatment
Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving
health through innovative tests that guide patient care, today
announced the publication of a study in the International Journal
of Radiation Oncology • Biology • Physics (Red Journal)
demonstrating the ability of the DecisionDx-SCC test to identify
high-risk cutaneous squamous cell carcinoma (SCC) patients at the
highest risk of metastasis who will benefit the most from ART to
reduce metastatic disease progression, as well as high-risk
patients who the test identified as having a lower risk of
metastasis who may consider deferring treatment. These results
demonstrate the impact of the test in guiding decision-making for
recommending ART.
“Radiation may be considered for patients with more aggressive
SCC tumors to reduce the risk of the cancer returning once the
tumor has been removed through surgery,” said Sarah T. Arron, M.D.
Ph.D., lead author and board-certified dermatologist and Mohs
surgeon at Peninsula Dermatology in Burlingame, California. “When
relying on current risk assessment and staging systems alone, it
can be very challenging to determine for which patients with
high-risk SCC the benefits of radiation therapy outweigh the
significant side effects and associated impacts on the patient’s
quality of life.
“The study found that DecisionDx-SCC test results can assist
clinicians in making these difficult decisions by identifying which
patients are most likely to benefit from the treatment.”
Key findings of the study (n=920 patients) include:
- The DecisionDx-SCC test identified patients projected to
receive the greatest benefit from ART to reduce metastatic disease
progression. Patients with a Class 2B (highest metastatic risk)
test result who were treated with ART had 50% higher MFS rates, on
average, than Class 2B patients who did not receive ART at five
years post-diagnosis.
- A DecisionDx-SCC Class 2B result was the only independent
risk factor that successfully identified patients who would most
benefit from ART. Risk factors in the analysis included
differentiation status, invasion into fat, perineural invasion and
others, including National Comprehensive Cancer Network (NCCN) risk
category and Brigham and Women's Hospital and American Joint
Committee on Cancer Eighth Edition T-stages.
- Class 2B patients who received ART showed a significant
deceleration in disease progression compared to Class 2B patients
who did not receive ART. For patients with a DecisionDx-SCC
Class 2B test result who were not treated with ART, there was a
peak rate of metastasis around two years; Class 2B, ART-treated
patients had nearly five times longer projected time to
metastasis.
- DecisionDx-SCC identified patients who were less likely to
show a significant benefit from ART in controlling disease
progression. Patients with high-risk clinicopathologic features
but who received a DecisionDx-SCC Class 1 (lower metastatic risk)
test result did not show a significant benefit from ART. Given the
low risk of metastasis for Class 1 patients, in addition to the
lower likelihood of ART benefit, Class 1 patients may consider
deferring treatment.
About DecisionDx-SCC
DecisionDx-SCC is a 40-gene expression profile test that uses an
individual patient’s tumor biology to stratify risk of metastasis
in patients with cutaneous squamous cell carcinoma who have one or
more NCCN high-risk factors. The test result, in which patients are
stratified into a Class 1 (lower), Class 2A (higher) or Class 2B
(highest) risk category, predicts individual metastatic risk to
inform risk-appropriate management and guide decision-making
regarding the use of adjuvant radiation therapy. Peer-reviewed
publications have demonstrated that DecisionDx-SCC is an
independent predictor of metastatic risk and that the test can
significantly improve risk-stratification when used with
traditional staging systems and clinicopathologic risk factors to
guide risk-aligned management and treatment decisions. Learn more
at www.CastleBiosciences.com.
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 continued ability of the
DecisionDx-SCC test to identify patients with high-risk SCC who
would most likely benefit from ART based on the biological risk of
metastasis. The words “can,” “may” 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 shown in this study,
including with respect to the discussion of DecisionDx-SCC 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 year ended December 31, 2023, our Quarterly Report on Form 10-Q
for the quarter ended March 31, 2024 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.
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Investor Contact: Camilla Zuckero
czuckero@castlebiosciences.com
Media Contact: Allison Marshall
amarshall@castlebiosciences.com
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