- Data obtained in real-life setting from more than 800
patients with node-negative or node-positive early-stage breast
cancer highlight the test's impact on clinical practice with
chemotherapy-sparing effect
- Publication of landmark TAILORx study results led to
greater reduction in chemotherapy recommendations
MADISON, Wisconsin,
May 14, 2020 /PRNewswire/
-- Exact Sciences Corp. (NASDAQ: EXAS) today announced results
from a prospective clinical survey of the Oncotype DX Breast
Recurrence Score® test, accepted at the 2020
American Society of Clinical Oncology (ASCO) Annual Meeting,
published online in the ASCO meeting library, and expected to
be published in the Journal of Clinical Oncology meeting's
proceedings. The findings, consistent with previous studies,
further support the unique value of the test in guiding
chemotherapy treatment decisions. Results also highlight the
practice-changing impact of the landmark TAILORx study, which
showed that the Oncotype DX® test identifies the vast
majority of women with node-negative disease who receive no
substantial benefit from chemotherapy (approximately 80%), as well
as the important minority (with a Recurrence Score result of
26-100) for whom chemotherapy can be life-saving.
The survey results1,2 at ASCO20 summarize
physicians' treatment decisions pre- and post-Recurrence Score
results in hospitals across Latin
America. A total of 647 patients (20% with one to three
positive nodes) were enrolled during routine care at 14 community
and academic sites in Argentina,
Colombia, Mexico, and Peru, while an additional 155 patients (34%
with one to three positive nodes) were treated at the largest
public breast cancer hospital in Brazil.
The analysis conducted in Argentina, Colombia, Mexico, and Peru included patients treated before and
after the June 2018 publication of
TAILORx. Overall, the findings revealed a 36% net decrease in
chemotherapy recommendations among patients with node-negative
disease and a 46% decrease in those with node-positive disease.
Importantly, the decrease in chemotherapy recommendations in
node-negative disease was greater following the publication of
TAILORx results and went from 28% to 36%.
Of the 155 patients treated in Brazil between August
2018 and April 2019, 70% were
classified as having high-risk disease based on traditional
clinical parameters, and the majority had tumors larger than 2
centimeters. A total of 151 of the 155 patients (97%) were
initially recommended chemotherapy in addition to hormonal therapy
based on clinical and pathological features. Based on their
Recurrence Score results, 104 of the 151 patients (69%) were spared
chemotherapy and received hormonal therapy alone instead.
Results from this public hospital show that clinical and
pathological features did not adequately identify patients most
likely to benefit from chemotherapy. Testing also led to economic
benefits and potential savings, suggesting that the Oncotype DX
test should be incorporated in the Brazilian public health
system.3
"Our findings highlight the unique value of the Oncotype DX test
and the practice-changing impact of the TAILORx results to select
patients for chemotherapy and to avoid overtreatment as well as
undertreatment," said Dr. Henry Gómez, lead study author and Head,
Breast Cancer Multidisciplinary Team, Oncosalud - AUNA,
Lima, Peru. "Overall, the
availability of Recurrence Score results led to substantial
reductions in chemotherapy use and allowed us to tailor treatment
plans more accurately and use resources more
effectively."
These results add to the substantial real-world evidence
available for the Oncotype DX test, which reflects its growing
adoption, particularly since the publication of TAILORx. This
landmark study has positively influenced treatment guidelines and
is having an important impact on global reimbursement and standard
use of the test. More than 1 million patients around the world have
used the test to inform their treatment decision.
"The practice-changing precision made possible by the Oncotype
DX test can lead to improved quality of care and better use of
healthcare resources by directing chemotherapy only to patients who
derive substantial benefit," said Torsten
Hoof, General Manager, International at Exact Sciences. "As
we continue to generate evidence showing the unique value of our
test, we look forward to continuing to work with the relevant
authorities to make it available to patients on a broader
international scale."
About Oncotype DX
The Oncotype DX portfolio of breast,
colon and prostate cancer tests applies advanced genomic science to
reveal the unique biology of a tumor in order to optimize cancer
treatment decisions. In breast cancer, the Oncotype DX Breast
Recurrence Score test is the only test that has been shown to
predict the likelihood of chemotherapy benefit as well as
recurrence in invasive breast cancer. Additionally, the Oncotype DX
Breast DCIS Score test predicts the likelihood of recurrence in a
pre-invasive form of breast cancer called DCIS. In prostate cancer,
the Oncotype DX Genomic Prostate Score® test predicts
disease aggressiveness and further clarifies the current and future
risk of the cancer prior to treatment intervention, and the
Oncotype DX AR-V7 Nucleus Detect™ test helps determine
which patients with metastatic castration-resistant prostate cancer
(mCRPC) are resistant to androgen receptor (AR)-targeted therapies.
The Oncotype DX AR-V7 Nucleus Detect test is performed by Epic
Sciences at its centralized, CLIA-certified laboratory in
San Diego and offered exclusively
by Exact Sciences. With more than 1 million patients tested in more
than 90 countries, the Oncotype DX tests have redefined
personalized medicine by making genomics a critical part of cancer
diagnosis and treatment. To learn more about Oncotype DX tests,
visit www.OncotypeIQ.com, www.MyBreastCancerTreatment.org or
www.MyProstateCancerTreatment.org.
About Exact Sciences Corp.
A leading provider of
cancer screening and diagnostic tests, Exact Sciences relentlessly
pursues smarter solutions providing the clarity to take
life-changing action, earlier. Building on the success of the
Cologuard® and Oncotype DX® tests,
Exact Sciences is investing in its product pipeline to take on some
of the deadliest cancers and improve patient care. Exact Sciences
unites visionary collaborators to help advance the fight against
cancer. For more information, please visit the company's website at
www.exactsciences.com, follow Exact Sciences on Twitter
@ExactSciences, or find Exact Sciences on Facebook.
NOTE: Oncotype, Oncotype DX, Breast Recurrence Score, DCIS
Score, Genomic Prostate Score, Oncotype DX AR-V7 Nucleus Detect,
and Oncotype IQ are trademarks or registered trademarks of Genomic
Health, Inc. Exact Sciences is a trademark or registered trademark
of Exact Sciences Corporation. All other trademarks and service
marks are the property of their respective owners.
Forward-Looking Statements
This news 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, that are intended
to be covered by the "safe harbor" created by those sections.
Forward-looking statements, which are based on certain assumptions
and describe our future plans, strategies and expectations, can
generally be identified by the use of forward-looking terms such as
"believe," "expect," "may," "will," "should," "would," "could,"
"seek," "intend," "plan," "goal," "project," "estimate,"
"anticipate" or other comparable terms. All statements other
than statements of historical facts included in this news release
regarding our strategies, prospects, expectations, financial
condition, operations, costs, plans and objectives are
forward-looking statements. Examples of forward-looking statements
include, among others, statements we make regarding expected future
operating results, anticipated results of our sales, marketing and
patient adherence efforts, expectations concerning payer
reimbursement, and the anticipated results of our product
development efforts. Forward-looking statements are neither
historical facts nor assurances of future performance. Instead,
they are based only on our current beliefs, expectations and
assumptions regarding the future of our business, future plans and
strategies, projections, anticipated events and trends, the economy
and other future conditions. Because forward-looking statements
relate to the future, they are subject to inherent uncertainties,
risks and changes in circumstances that are difficult to predict
and many of which are outside of our control. Actual results,
conditions and events may differ materially from those indicated in
the forward-looking statements. Therefore, you should not rely on
any of these forward-looking statements. Important factors that
could cause actual results, conditions and events to differ
materially from those indicated in the forward-looking statements
include, among others, the following: uncertainties associated with
the coronavirus (COVID-19) pandemic, including its possible effects
on our operations and the demand for our products and services; our
ability to efficiently and flexibly manage our business amid
uncertainties related to COVID-19; our ability to successfully and
profitably market our products and services; the acceptance of our
products and services by patients and healthcare providers; our
ability to meet demand for our products and services; the success
of our efforts to facilitate patient access to Cologuard via
telehealth; the willingness of health insurance companies and other
payers to cover our products and services and adequately reimburse
us for such products and services; the amount and nature of
competition for our products and services; the effects of the
adoption, modification or repeal of any law, rule, order,
interpretation or policy relating to the healthcare system,
including without limitation as a result of any judicial, executive
or legislative action; the effects of changes in pricing, coverage
and reimbursement for our products and services, including without
limitation as a result of the Protecting Access to Medicare Act of
2014; recommendations, guidelines and quality metrics issued by
various organizations such as the U.S. Preventive Services Task
Force, the American Society of Clinical Oncology, the American
Cancer Society, and the National Committee for Quality Assurance
regarding cancer screening or our products and services; our
ability to successfully develop new products and services and
assess potential market opportunities; our ability to effectively
enter into and utilize strategic partnerships, such as through our
Promotion Agreement with Pfizer, Inc., and acquisitions; our
success establishing and maintaining collaborative, licensing and
supplier arrangements; our ability to maintain regulatory approvals
and comply with applicable regulations; our ability to manage an
international business and our expectations regarding our
international expansion and opportunities; the potential effects of
foreign currency exchange rate fluctuations and our efforts to
hedge such effects; the possibility that the anticipated benefits
from our combination with Genomic Health cannot be realized in full
or at all or may take longer to realize than expected; the
possibility that costs or difficulties related to the integration
of Genomic Health's operations will be greater than expected and
the possibility of disruptions to our business during integration
efforts and strain on management time and resources; the outcome of
any litigation, government investigations, enforcement actions or
other legal proceedings; and the other risks and uncertainties
described in the Risk Factors and in Management's Discussion and
Analysis of Financial Condition and Results of Operations sections
of our most recently filed Annual Report on Form 10-K and our
subsequently filed Quarterly Reports on Form 10-Q. We undertake no
obligation to publicly update any forward-looking statement,
whether written or oral, that may be made from time to time,
whether as a result of new information, future developments or
otherwise.
1 Gomez H et al. Abstract #e12539, ASCO
2020.
2 Mattar A et al. Abstract #e12518, ASCO 2020.
3 Mattar A et al. Abstract #e19380, ASCO 2020.
Investors:
|
Media
(U.S.):
|
Media (Canada,
Europe, Asia, Latin America):
|
Megan
Jones
|
Stephanie
Spanos
|
Federico
Maiardi
|
+1
608-535-8815
|
+1
608-556-4380
|
+41
79-138-1326
|
meganjones@exactsciences.com
|
sspanos@exactsciences.com
|
fmaiardi@exactsciences.com
|
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