[August 29, 2017] |
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Castle Biosciences' DecisionDx-Melanoma Test Performance Demonstrated in Newly Expanded Multicenter Cohort of 782 Patients
Castle Biosciences, Inc., a provider of molecular diagnostics to improve
cancer treatment decisions, today announced that results of the
DecisionDx®-Melanoma prognostic test's performance in a
cumulative cohort of 782 patients with cutaneous melanoma were presented
during the 23rd International Pigment Cell Conference (IPCC
2017) held in Denver, CO from August 26-30. In the study cohort,
DecisionDx-Melanoma demonstrated improved clinical risk assessment
beyond current methods of prognostication, consistent with findings from
previous retrospective and prospective studies.
The study titled, "Continued Evaluation of a 31-Gene Expression Profile
to Predict Metastasis in an Expanded Cohort of 782 Cutaneous Melanoma
Patients" (abstract 5175), combined results from 261 newly analyzed
tumor samples with data from three previous DecisionDx-Melanoma
validation studies, exclusive of the training set. In this cumulative
population of 782 Stage I-IV patients, median age was 60 years and
median time of follow-up was 6.9 years. The DecisionDx-Melanoma gene
expression profile (GEP) test was performed to determine molecular class
for each patient, with a Class 1 result indicating low 5-year risk of
metastasis and a Class 2 result indicating high risk. Study endpoints
included recurrence-free survival (RFS; time to regional or distant
metastatic event), distant metastasis-free survival (DMFS; time to any
metastatic event beyond the regional nodal basis) and melanoma-specific
survival (MSS; time from diagnosis to death from melanoma).
Key Study Findings:
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Results from this expanded multicenter cohort show the prognostic
accuracy of the DecisionDx-Melanoma test with 5-year RFS rates of 89%
for Class 1 (low risk) and 49% for Class 2 (high risk) patients
(p<0.0001). DMFS 5-year rates were 93% for Class 1 and 59% for Class 2
(p<0.0001), while MSS 5-year rates were 98% for Class 1 and 81% for
Class 2 (p<0.0001).
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Using Cox (News - Alert) multivariate analysis, DecisionDx-Melanoma test class,
Breslow thickness and node positive status were found to be
significant predictors of RFS, DMFS and MSS (p<0.05 for all).
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Class 2 patients who experienced a metastasis had a median time to
event of 1.1 years.
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For patients who had undergone a sentinel lymph node (SLN) biopsy
procedure (n=506), the RFS rate was 87% for patients who were both SLN
negative and Class 1 (compared to 74% for node negative status alone)
and 32% for those who were SLN positive and Class 2 (compared to 41%
for SLN positivity alone; see table below).
Analysis of RFS and DMFS for combined DecisionDx-Melanoma and SLN
predicted outcomes
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RFS
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DMFS
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N
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5-year survival rate
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# events (event rate)
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5-year survival rate
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# events (event rate)
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Class 1/SLN negative
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159
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87%
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23 (14%)
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92%
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16 (10%)
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Class 1/SLN positive
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63
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59%
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27 (43%)
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72%
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19 (30%)
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Class 2/SLN negative
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146
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60%
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59 (40%)
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73%
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40 (27%)
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Class 2/SLN positive
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138
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32%
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91 (66%)
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41%
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76 (55%)
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"These results show the accuracy and performance of the
DecisionDx-Melanoma prognostic test in a large combined cohort of
patients from our validation studies, demonstrating that the test
provides valuable information about a patient's individual risk of
metastasis that is independent of and complementary to traditional
staging tools," commented Federico A. Monzon, M.D., FCAP, Chief Medical
Officer of Castle Biosciences. "We believe that use of the
DecisionDx-Melanoma test can help improve identification of patients at
high risk for distant metastasis, enabling implementation of management
plans that are consistent with their individual risk."
The poster can be found in the Publications
section of the Castle Biosciences website.
About DecisionDx-Melanoma The DecisionDx-Melanoma test uses
tumor biology to provide a prediction of individual risk of melanoma
recurrence beyond traditional factors. Using tissue from the primary
melanoma, the test measures the expression of 31 genes. The test has
been validated in three multicenter studies that have included 690
patients and have demonstrated consistent results. Performance has also
been confirmed in three independent, prospective studies including 510
patients. The consistent high performance and accuracy demonstrated in
these studies, which combined have included 1200 patients, provides
confidence in disease management plans that incorporate
DecisionDx-Melanoma test results. Clinical impact has been demonstrated
in a multicenter and single-center study showing that test results add
additional patient-specific prognostic information to complement
traditional staging tools. More information about the test and disease
can be found at www.SkinMelanoma.com.
About Castle Biosciences Castle Biosciences is a molecular
diagnostics company dedicated to helping patients and their physicians
make the best possible treatment and follow-up care decisions based on
the individual molecular signature of their tumor. The Company currently
offers tests for patients with cutaneous melanoma (DecisionDx®-Melanoma;
www.SkinMelanoma.com)
and uveal melanoma (DecisionDx®-UM and DecisionDx®-PRAME; www.MyUvealMelanoma.com),
with development programs in other underserved cancers. Castle
Biosciences is based in Friendswood, TX (Houston), and has laboratory
operations in Phoenix, AZ. More information can be found at www.CastleBiosciences.com.
DecisionDx-UM, DecisionDx-Melanoma and DecisionDx-PRAME are the
trademarks of Castle Biosciences, Inc. Any other trademarks are the
property of their respective owners.
View source version on businesswire.com: http://www.businesswire.com/news/home/20170829005370/en/
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