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Myriad Genetics, Inc.
, a global leader in molecular diagnostics, announced the
presentation of new data at the American Society of Clinical Oncology (ASCO)
meeting this week that supports the clinical efficacy of its BRACAnalysis CDx™
and HRD™ tests in predicting platinum based therapy response for breast cancer
patients. Additionally, the company is providing an update on key commercial
milestones that underscore its commitment to the field of companion
diagnostics.
"Myriad is committed to advancing the science of companion diagnostics and is
currently working with approximately 20 different pharmaceutical companies on
companion diagnostic programs," said Mark Capone, president of Myriad Genetic
Laboratories. "We believe the future of pharmaceuticals depends on providing
therapeutics to patients that are tailored to their individual genetic makeup,
and we are investing substantial resources to maintain our global leadership
position in this field."
Data on BRACAnalysis CDx in Metastatic Breast Cancer Patients
At this week's ASCO meeting, Myriad will present data supporting BRACAnalysis
CDx's ability to predict platinum response in metastatic breast cancer
patients. In a trial of 86 patients, the response rates to platinum based
therapies (carboplatin and cisplatin) for patients with deleterious mutations
detected by BRACAnalysis CDx (the Company's proprietary companion diagnostic
test for deleterious mutations and large rearrangements in the BRCA1 and BRCA2
genes) was 54.5 percent compared to only 19.7 percent in the non-carrier
group. These data underscore the ability of BRACAnalysis CDx to predict
patient response to platinum based therapies in a patient population
characterized by low overall response rates.
Myriad is making substantial progress toward the commercialization of
BRACAnalysis CDx for PARP inhibitors and several of Myriad's commercial
pharmaceutical partners have recently made major announcements on the
advancement and expansion of their PARP inhibitor programs. Below is a table
summarizing the announced, late-stage clinical trials by commercial partners
in which Myriad is providing the companion diagnostic test in support of the
drug.
Company Drug Clinical Trial Timeline Myriad Test
Phase/Indications
AstraZeneca Phase 3 – platinum Expect U.S. FDA and
olaparib sensitive relapsed EMA approval for BRACAnalysis
ovarian cancer platinum sensitive CDx™
ovarian cancer in
Phase 3 – first CY15. Expect to file
line maintenance with the FDA for
therapy for ovarian breast cancer in
cancer CY16.
Phase 3 – metastatic
breast cancer
Phase 3 – neoadjuvant
breast cancer
Phase 3 – adjuvant
breast cancer
Biomarin BMN-673 Phase 3 – metastatic NA BRACAnalysis
breast cancer CDx™
Phase 3 – neoadjuvant BRACAnalysis
AbbVie veliparib treatment of triple NA CDx™
negative breast cancer
Phase 3 – platinum BRACAnalysis
Tesaro niraparib sensitive ovarian NA CDx™
cancer
Phase 3 – metastatic
breast cancer
"In the area of cancer, we are seeing significant progress by our
pharmaceutical partners in the advancement of PARP inhibitors toward
commercialization in a variety of cancer types and we are excited to be
providing best-in-class diagnostics in support of these important
therapeutics," said Capone. "Myriad is uniquely positioned as a global
diagnostic company to provide these highly complex tests with the accuracy and
turnaround times required to have a positive impact on patient care."
New Data on Myriad's Proprietary HRD Test Supports Planned Commercial Launch
in FY15
Myriad also will present data looking at the ability of the Company's
proprietary HRD tumor test in terms of its ability to predict response among
triple negative breast cancer patients. The combination of Myriad's three HRD
assays including Loss of Heterogyzosity (LOH), Telomere Allelic Imbalance
(TAI), and Large-Scale State Transition (LST) were highly correlated with
patient response rates. These data further highlight the likely utility of HRD
as a more comprehensive companion diagnostic for DNA damaging agents.
In addition, Myriad announced a new 160 patient randomized study evaluating
HRD as a biomarker for prediction of cisplatin and paclitaxel response in
triple negative breast cancer patients at diagnosis. This is one of several
ongoing clinical trials Myriad is conducting looking at the predictive power
of HRD in guiding platinum based therapy. Myriad plans to present data later
this year on HRD that will support an early access launch of the test in
triple negative breast cancer patients in late fiscal year 2015.
"High HRD scores have been shown in early research to be highly correlated
with response rates to DNA damaging agents such as platinum based therapies,"
said Jerry Lanchbury, chief scientific officer at Myriad Genetics. "We believe
that, with further validation, the HRD test has the potential to become the
gold standard diagnostic to identify patients who have lost DNA repair
function and are most suitable for this class of therapeutics."
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