Castle Biosciences Presents New Data at ASTRO 2023 Highlighting Risk-Stratification Performance of DecisionDx®-SCC in Patients with Cutaneous Squamous Cell Carcinoma Eligible for Adjuvant Radiation Therapy
03 Outubro 2023 - 8:00AM
Business Wire
Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving
health through innovative tests that guide patient care, will share
new data demonstrating the ability of its DecisionDx®-SCC test to
identify node-negative cutaneous squamous cell carcinoma (SCC)
patients at a higher risk of metastasis who may benefit from
adjuvant radiation therapy (ART). The data will be shared in an
oral presentation during the American Society for Radiation
Oncology (ASTRO) 2023 Annual Meeting, being held Oct. 1-4 in San
Diego.
“Risk stratification for patients with SCC can be challenging
due to broad staging guidelines based on a wide range of
clinicopathologic risk factors,” said Jason Newman, M.D., study
author and director of the Head & Neck Cancer Division at
Medical University of South Carolina. “When a patient’s risk of
metastasis is unclear, tough decisions as to which treatment
approaches to pursue become that much more difficult.
DecisionDx-SCC complements traditional risk stratification with
independent and objective information on a patient’s biologic risk
of metastasis that can be invaluable in guiding risk-aligned
treatment decisions, such as consideration of radiation therapy for
a patient.”
Details regarding Castle’s presentation are as follows:
Abstract ID 1180: Risk-stratification using the 40-gene
expression profile (40-GEP) test identifies patients with node
negative cutaneous squamous cell carcinoma (cSCC) at higher risk of
metastasis who may benefit from adjuvant radiation therapy
(ART) Session #: QP 16 Session: H&N 3: Innovative
Approaches to Individualizing Therapy for Head & Neck and Skin
Cancer Date & Time: Tuesday, Oct. 3 from 5:15-6:15 p.m. Pacific
Time
The study aimed to evaluate whether DecisionDx-SCC (40-GEP) test
results could refine the ability to select node negative SCC
patients at a higher risk of metastasis who are most likely to
benefit from ART. An intermediate risk population in which ART is
often considered was defined as Brigham and Women’s Hospital (BWH)
stage T2a or higher (n=489). DecisionDx-SCC significantly
stratified the cohort according to risk of metastasis, with
metastasis-free survival (MFS) rates of 92.4%, 76.1% and 59.4% for
patients with Class 1 (low biological risk of metastasis), Class 2A
(moderate risk) and Class 2B (high risk) test results, respectively
(p<0.0001). Cox regression analysis demonstrated a significant
difference in Class 2A and 2B MFS compared to Class 1, with a
3.2-fold and 6.4-fold increase in metastasis, respectively
(p<0.0001).
Nearly half of the ART-eligible cohort (46%) received a
DecisionDx-SCC Class 1 test result and had a less than 10% risk of
metastasis, identifying a population whose treatment could
potentially be de-intensified. Conversely, patients with low-risk
BWH T1 stage, who are traditionally not considered for ART, that
received a Class 2A or 2B test result had a greater than 10% risk
of metastasis and could be considered for adjuvant therapy.
Abstracts will be published in the International Journal of
Radiation Oncology • Biology • Physics (Red Journal).
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 (moderate) or Class 2B
(high) 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. More information about
the disease and test can be found at www.CastleTestInfo.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,
uveal melanoma, Barrett’s esophagus and mental health conditions.
Additionally, the Company has active research and development
programs for tests in other 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. 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, DecisionDx-UM, DecisionDx-PRAME, DecisionDx-UMSeq,
TissueCypher and IDgenetix 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 potential of DecisionDx-SCC
test results to identify node-negative cutaneous SCC patients at a
higher risk of metastasis who may benefit from ART and provide
information that can be invaluable in guiding risk-aligned
treatment decisions, such as consideration of radiation therapy for
a patient. 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, 2022, 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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version on businesswire.com: https://www.businesswire.com/news/home/20231003841826/en/
Investor Contact: Camilla Zuckero
czuckero@castlebiosciences.com
Media Contact: Allison Marshall
amarshall@castlebiosciences.com
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