Analysis of Newly Expanded Cumulative Cohort Demonstrates that DecisionDx-Melanoma Improves Risk Prediction for Patients with...
06 Juni 2019 - 1:00PM
Business Wire
Poster presentation at 2019 Fall Clinical
Dermatology Conference for PAs & NPs
Castle Biosciences, Inc., a skin cancer diagnostics company
providing personalized genomic information to improve cancer
treatment decisions, today announced the presentation of newly
expanded performance results for DecisionDx®-Melanoma at the 2019
Fall Clinical Dermatology Conference for PAs & NPs held in
Scottsdale, Arizona. The poster, titled “The prognostic 31-gene
expression profile (31-GEP) test improves risk prediction in
cutaneous melanoma (CM) patients within current AJCC stages,”
demonstrated the utility of DecisionDx-Melanoma in identifying risk
for patients with cutaneous melanoma beyond traditional
staging.
Using a newly expanded performance cohort of 901 archival
cutaneous melanoma samples (211 of which were not previously
reported) from 22 centers, the analysis was designed to examine
whether incorporating the DecisionDx-Melanoma test result in
treatment decisions improves upon traditional melanoma staging
methods. Patients assessed in the expanded cohort had a median age
of 60 years and a median Breslow thickness of 1.4 mm. Forty-four
percent of melanomas were American Joint Committee on Cancer (AJCC)
Stage I, 24% were Stage II and 32% were Stage III.
Key Study Findings
- DecisionDx-Melanoma was a significant
and independent predictor of recurrence-free survival, distant
metastasis-free survival and melanoma-specific survival (MSS) in
the cumulative cohort of 901 cutaneous melanoma patients.
- Within each AJCC stage,
DecisionDx-Melanoma further stratified risk of melanoma-specific
mortality. Using AJCC staging alone, patients with Stage I melanoma
have an estimated 5-year MSS rate of 98%. Within that group, those
with a Class 1A (lowest risk) DecisionDx-Melanoma test result had
an estimated 5-year MSS rate of 99.7%, a risk equivalent to AJCC
Stage IA. Stage I, Class 2B (highest risk) patients had a 92.8%
5-year MSS rate, lower than patients with Stage IIIA disease.
- Patients with Stage II cutaneous
melanoma have an estimated 5-year MSS rate of 90% using AJCC
staging alone. Stage II patients who had a Class 1A
DecisionDx-Melanoma test result had a 5-year MSS rate of 97%,
equivalent to Stage IB. The MSS rate for Stage II patients with a
Class 2B test result was 87.4%, aligned with risk estimates for
AJCC Stage IIB.
“Accurate risk assessment in cutaneous melanoma is important
because most treatment decisions are based on the patient’s
expected risk of metastasis or recurrence,” commented study
co-author Darrell S. Rigel, M.D., M.S., Clinical Professor at New
York University School of Medicine. “These results show that
DecisionDx-Melanoma provided a more comprehensive assessment of
patient risk compared to AJCC staging alone, supporting its utility
in developing individualized patient management plans.”
The poster can be found in the Publications section of the
Castle Biosciences website.
About DecisionDx-Melanoma
DecisionDx-Melanoma is a gene expression profile test that uses
an individual patient’s tumor biology to predict individual risk of
cutaneous melanoma metastasis or recurrence, as well as sentinel
lymph node positivity, independent of traditional staging factors,
and has been studied in more than 3,100 patient samples. Using
tissue from the primary melanoma, the test measures the expression
of 31 genes. The test has been validated in four archival risk of
recurrence studies of 901 patients and five prospective risk of
recurrence studies including more than 780 patients. Prediction of
the likelihood of sentinel lymph node positivity has also been
validated in two prospective multicenter study cohorts that
included more than 1,400 patients. Impact on patient management
plans for one of every two patients tested has been demonstrated in
four multicenter and single-center studies including more than 560
patients. The consistent performance and accuracy demonstrated in
these studies provides confidence in disease management plans that
incorporate DecisionDx-Melanoma test results.
More information about the test and disease can be found at
www.SkinMelanoma.com.
About Castle Biosciences
Castle Biosciences is a skin cancer diagnostics company
dedicated to helping patients and their physicians make more
informed decisions about treatment and follow-up care based on the
individual molecular signature of the patient’s tumor. The Company
currently offers tests for patients with cutaneous melanoma
(DecisionDx®-Melanoma, DecisionDx®-CMSeq; www.SkinMelanoma.com) and
uveal melanoma (DecisionDx®-UM, DecisionDx®-PRAME and
DecisionDx®-UMSeq; www.MyUvealMelanoma.com), with products in
development for other underserved cancers, the most advanced of
which is focused on patients with cutaneous squamous cell
carcinoma. Castle Biosciences is based in Friendswood, Texas
(Houston), and has laboratory operations in Phoenix, Arizona. More
information can be found at www.CastleBiosciences.com.
DecisionDx-Melanoma, DecisionDx-CMSeq, DecisionDx-UM,
DecisionDx-PRAME and DecisionDx-UMSeq are the trademarks of Castle
Biosciences, Inc. Any other trademarks are the property of their
respective owners.
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Derek Maetzold, President and
CEO866-788-9007IR@castlebiosciences.com