Castle Biosciences to Present New Data at 2024 ASCO® Annual Meeting Highlighting Use of DecisionDx®-Melanoma to Identify Early-Stage Melanoma Patients at High Risk of Metastasis to the Central Nervous System to Prompt Use of Imaging Surveillance
May 30 2024 - 4:30PM
Business Wire
Castle to present a second poster on its
DecisionDx®-UM test sharing data from an ongoing prospective,
multi-center study of patients with uveal melanoma (UM) led by the
Collaborative Ocular Oncology Group (COOG2)
Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving
health through innovative tests that guide patient care, today
announced that it will present new data related to its
DecisionDx-Melanoma and DecisionDx-UM tests at the 2024 American
Society of Clinical Oncology (ASCO) Annual Meeting, being held May
31-June 4, 2024, in Chicago.
“Harnessing the biology of tumors through our DecisionDx family
of gene expression profile tests can help guide decision-making
about the most appropriate cancer treatment pathway for patients
aligned to their risk of metastasis,” said Derek Maetzold,
president and chief executive officer of Castle Biosciences. “The
findings we are presenting at ASCO demonstrate the clinically
meaningful risk stratification provided by our tests and support
their utility in helping inform risk-aligned treatment and care for
patients diagnosed with cutaneous and uveal melanoma to improve
cancer outcomes.”
Castle’s presentations at ASCO will take place during the
Melanoma/Skin Cancers poster session on Saturday, June 1 from
1:30-4:30 p.m. Central time in Hall A.
DecisionDx-Melanoma
- Title: The 31-GEP identifies patients with localized cutaneous
melanoma at the highest risk of metastasis to the central nervous
system
- Abstract: 9530
- Poster Bd #: 314
- Key take-aways: Cutaneous melanoma (CM) metastasis to the
central nervous system (CNS) has a poor prognosis; however,
patients generally experience better outcomes if CNS metastases are
detected and treated earlier when the patient is still
asymptomatic. CNS imaging is not routinely recommended for patients
with early-stage CM (American Joint Committee on Cancer 8th edition
(AJCC8) stage I–II), yet approximately 14% of patients with stage
II melanoma will develop CNS metastases. This study demonstrated
that the DecisionDx-Melanoma test can identify patients with
earlier-stage melanoma who have a higher risk of CNS metastasis
within the first three years post-diagnosis. These higher-risk
patients may benefit from more frequent imaging surveillance to
identify CNS metastases earlier to improve patient survival.
Patients with Class 2B (highest risk) DecisionDx-Melanoma test
results had higher rates of CNS metastases and lower five-year
recurrence free survival than patients with Class 1A (lowest risk)
or Class 1B/2A (increased risk) test results (p<0.001). Further,
the study showed that a Class 2B (high risk) DecisionDx-Melanoma
test result was the only significant predictor of CNS metastasis in
multivariable analyses that included clinicopathologic-based risk
factors considered in AJCC8 staging (HR (95% CI) 9.21 (2.72-31.19);
p<0.001).
DecisionDx-UM
- Title: The 15-gene expression profile test is independent
from PRAME and 7-gene next-generation sequencing: Results from
3,267 clinically tested uveal melanomas
- Abstract: 9598
- Poster Bd #: 382
- Key take-aways: This study is the largest to date to describe
the combined performance of Castle’s comprehensive suite of UM
tests, which includes the prognostic DecisionDx-UM test and two
ancillary tests: Preferentially Expressed Antigen in Melanoma
(PRAME) status (DecisionDx-PRAME) and DNA mutation status
(DecisionDx-UMSeq). The study explored associations across test
results and found that neither PRAME expression status nor the
presence of mutations in putative prognostic genes (BAP1, SF3B1 and
EIF1AX) to be adequate surrogates for the DecisionDx-UM Class
result. Given the extensive data supporting DecisionDx-UM as the
most accurate predictor of metastatic outcomes, including recently
presented data from the largest prospective performance study of
DecisionDx-UM to date, which included more than 1,500 patients from
26 centers, study authors recommend that PRAME and DNA mutation
status be considered in the context of a DecisionDx-UM result to
further refine metastatic risk and inform risk-aligned treatment
plans.
The full abstracts outlined above can be found at the ASCO
website here.
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 March 31, 2024, DecisionDx-Melanoma has been ordered more
than 164,000 times for patients diagnosed with cutaneous melanoma.
More information about the test and disease can be found here.
About DecisionDx-UM
DecisionDx-UM is Castle Biosciences’ 15-gene expression profile
(GEP) test that uses an individual patient’s tumor biology to
predict individual risk of metastasis in patients with uveal
melanoma (UM). DecisionDx-UM is the standard of care in the
management of newly diagnosed UM in the majority of ocular oncology
practices in the United States. Since 2009, the American Joint
Committee on Cancer (AJCC; v7 and v8) Staging Manual for UM has
specifically identified the GEP test as a prognostic factor that is
recommended for collection as a part of clinical care. Further, the
National Comprehensive Cancer Network (NCCN) guidelines for UM
include the DecisionDx-UM test result as a prognostic method for
determining risk of metastasis and recommend differential
surveillance regimens based on a Class 1A, 1B and 2 result.
DecisionDx-UM is currently the only prognostic test for UM that has
been validated in prospective, multi-center studies, and it has
been shown to be a superior predictor of metastasis compared to
other prognostic factors, such as chromosome 3 status, mutational
status, AJCC stage and cell type. It is estimated that nearly 8 in
10 patients diagnosed with UM in the United States receive the
DecisionDx-UM test as part of their diagnostic workup. More
information about the test and disease can be found here.
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: (i) the ability of the
DecisionDx-Melanoma test to identify patients with earlier-stage
melanoma who have a higher risk of CNS metastasis within the first
three years post-diagnosis and (ii) the ability of DecisionDx-UM
test to accurately predict metastatic outcomes. The words
“believe,” “can,” “could,” “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 results obtained in these studies,
including with respect to the discussion of our tests 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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