Oral presentation at ARVO shares
ground-breaking findings from the ongoing Collaborative Ocular
Oncology Group (COOG) study 2 (COOG2) of patients with uveal
melanoma (UM)
Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving
health through innovative tests that guide patient care, today
announced new data from a study further confirming the performance
of its DecisionDx-UM test as a robust independent predictor of
metastasis-free survival (MFS) in patients diagnosed with UM.
Further, the study provides prospective validation data supporting
Preferentially Expressed Antigen in Melanoma (PRAME) as a risk
refinement tool when considered in the context of a Class 1 or
Class 2 DecisionDx-UM test result. The data was presented at the
Association for Research in Vision and Ophthalmology (ARVO) 2024
Annual Meeting in Seattle.
Uveal melanoma is an aggressive cancer of the eye, and despite
high primary tumor cure rates, metastatic disease spread eventually
impacts about half of all patients.1 The DecisionDx-UM test is
considered the standard of care in the management of newly
diagnosed UM to assist in determining risk of metastasis, which is
critical for informing appropriate treatment plans.
“The latest findings from the COOG2 study not only further
support DecisionDx-UM’s ability to predict metastatic risk, but
also highlight the utility of PRAME as a valuable adjunct biomarker
for further risk refinement when considered in conjunction with a
DecisionDx-UM result,” said lead study author and COOG investigator
Zelia Correa, M.D., Ph.D., professor of ophthalmology and director
of ocular oncology at the Bascom Palmer Eye Institute and Sylvester
Comprehensive Cancer Center of the University of Miami Miller
School of Medicine. “The study data provides support for combining
the reported expression status of the PRAME gene with the
DecisionDx-UM class result to enhance metastatic risk prediction.
Specifically, distinguishing between PRAME-negative (-) and
PRAME-positive (+) subgroups within DecisionDx-UM Class 1 and Class
2 tumors provides additional biological insights into an individual
patient’s likelihood of metastasis. This information can be
utilized to optimize surveillance and guide more nuanced and
risk-aligned treatment decisions.”
Details regarding the presentation at ARVO are included
below:
- Oral Presentation Title: Collaborative Ocular
Oncology Group study 2 (COOG2): Prospective multi-center validation
of the 15-gene expression profile (GEP)/PRAME molecular prognostic
tool for uveal melanoma in 1586 patients
- Session Type: Paper Session (Wednesday, May 8)
- Presentation Number: 4273
- Summary: This prospective, multi-center study included
1,586 patients with posterior UM tumors enrolled across 26 ocular
oncology centers in the United States and Canada. In the study, a
DecisionDx-UM Class 2 result was the most robust independent
predictor of MFS (HR 6.03; 95% CI, 4.49-8.09); P<0.001),
followed by PRAME status (HR 1.77; 95% CI, 1.39-2.27; P<0.001).
Patients with Class 2 tumors had considerably worse outcomes than
those with Class 1 tumors, regardless of PRAME status; however,
PRAME+ tumors fared worse within each GEP class (versus PRAME-).
When considered together, five-year MFS rates were 95.6% (95% CI,
93.9-97.4) for Class 1/PRAME-, 80.6% (73.9-87.9) for Class
1/PRAME+, 57.6% (50.6-65.7) for Class 2/PRAME- and 44.8%
(38.0-52.8) for Class 2/PRAME+. Overall, the study confirms the
prognostic accuracy of the DecisionDx-UM test and provides the
first prospective validation of PRAME status as a risk refinement
tool when considered in the context of a Class 1 or Class 2
DecisionDx-UM result. These two tests together can guide more
precise and risk-aligned decision-making for patients with UM,
including referrals, intensity of imaging surveillance and
eligibility for ongoing clinical trials.
J. William Harbour, M.D., ophthalmologist, ocular oncologist,
and professor and chair of the department of ophthalmology at UT
Southwestern Medical Center, is a leading innovator in the
treatment and study of UM and an executive committee member of the
COOG. As the original developer of the DecisionDx-UM test, which
was licensed to Castle in 2009, Harbour continues to drive
important advancements in the treatment of UM and co-authored this
study with Correa.
The presented abstract described above can be viewed online in
the ARVO Meeting Planner.
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 recommended 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 DecisionDx®-PRAME
Castle Biosciences offers testing with DecisionDx-PRAME as an
optional add-on to the DecisionDx-UM test. PRAME (preferentially
expressed antigen in melanoma) is an antigen gene that is not
expressed at appreciable levels in normal adult tissues, but its
expression can become aberrantly increased in some types of cancer,
including melanoma. Once expressed, the PRAME protein can be
processed and presented on the surface of cells, thereby serving as
a potential target for therapeutic intervention. PRAME-directed
therapies are being explored in multiple cancer types, including
uveal melanoma. More information about DecisionDx-PRAME can be
found here.
About the Collaborative Ocular Oncology Group
The Collaborative Ocular Oncology Group (COOG) is the largest
collaborative working group in North America comprised of ocular
and medical oncologists specialized in the treatment of patients
with intraocular cancers, currently focusing on UM. The group is
dedicated to a collaborative, evidence-based approach to advancing
the care of patients with UM and other eye cancers through
precision diagnostic, prognostic and therapeutic breakthroughs.
Comprised of more than 25 leading academic and private ocular
oncology centers of excellence, the COOG has been continually
funded by the National Cancer Institute for over a decade. The COOG
has conducted two large multi-center prospective studies of
prognostic biomarkers in UM, the first and only such studies ever
conducted in this cancer to date, and is planning a major expansion
into adjuvant and metastatic clinic trials in patients with UM.
More information about the COOG 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-UM test to assist in determining risk of metastasis to
inform appropriate treatment plans; (ii) the utility of PRAME as a
valuable biomarker when considered in conjunction with a
DecisionDx-UM test result; and (iii) the ability of the
DecisionDx-UM test and PRAME to guide more nuanced and risk-aligned
treatment decisions for patients with UM, including referrals,
intensity of imaging surveillance and eligibility for ongoing
clinical trials. The words “can,” “would” 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-UM in this
press release; actual application of our DecisionDx-UM test 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.
- Kujala E, Mäkitie T, Kivelä T. Very long-term prognosis of
patients with malignant uveal melanoma. Invest Ophthalmol Vis Sci.
2003 Nov 1;44(11):4651.
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Investor Contact: Camilla Zuckero
czuckero@castlebiosciences.com
Media Contact: Allison Marshall
amarshall@castlebiosciences.com
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