Data to be presented expands the body of
evidence around the predictive and prognostic value of the Oncotype
DX® test in all racial and ethnic groups
New data showcase Exact Sciences’ commitment to
innovation and strategies that expand access to effective cancer
screening and diagnostic tools for patients
Exact Sciences Corp. (Nasdaq: EXAS), a leading provider of
cancer screening and diagnostic tests, will present 10 abstracts
highlighting the breadth and depth of the company’s screening and
diagnostic portfolio at the American Society of Clinical Oncology®
(ASCO®) Annual Meeting, taking place May 31 – June 4, 2024, in
Chicago, Ill. Presentations will include new data confirming both
the predictive and prognostic value of the Oncotype DX Breast
Recurrence Score® test in racially and ethnically diverse patients.
Exact Sciences will also present data on its approach to
multi-cancer early detection (MCED) across multiple tumor types,
plus additional real-world evidence showing optimized screening
adherence strategies for the Cologuard® test as well as high
adherence rates for repeat screenings.
“Exact Sciences’ growing evidence shows that earlier and more
personalized treatment interventions lead to greater success for
people living with cancer. Therefore, effective cancer screening
and diagnostic tools are critical to improving patient outcomes,”
said Dr. Rick Baehner, Chief Medical Officer, Precision Oncology at
Exact Sciences. “These data presented at ASCO support our goal to
set new screening and diagnostic standards through rigorous
innovation and real-world data collection across cancer care. We
are committed to continuing to develop high-quality tests that meet
the needs of all patients, regardless of race, age, or
ethnicity.”
Precision Oncology
New data from two studies evaluating Recurrence Score® results
showed that the Oncotype DX Breast Recurrence Score test predicted
breast cancer survival across different racial and ethnic groups.
The first study confirmed that the test is prognostic for breast
cancer-specific mortality and predictive of chemotherapy benefit
across racial and ethnic groups in lymph node-negative patients,
following propensity score-adjusted analyses. This real-world study
of more than 171,000 patients with nonmetastatic, hormone
receptor-positive, HER2-negative breast cancer with a Recurrence
Score result from the SEER database also showed that the Recurrence
Score result was predictive of chemotherapy benefit across all
node-positive patients. In the study, non-Hispanic Black patients
were shown to have a higher Recurrence Score result and
chemotherapy usage compared to other groups. Exploratory analyses
of the RxPONDER trial showed that while the test remained
prognostic across racial and ethnic groups, non-Hispanic Black
patients had higher proliferation axis scores, suggesting that
differences in tumor biology may help explain differences in breast
cancer outcomes.
Screening
New data suggests benefits of multi-cancer early detection
(MCED) in identifying cancers earlier, with patients having a
shorter time to diagnosis and fewer late-stage (Stage IV)
diagnoses. In a modeling analysis, when MCED was evaluated across
12 different cancer types, it resulted in fewer Stage IV diagnoses
relative to diagnosis through usual care, with 38% of Stage IV
reductions attributed to cancers without recommended screening
guidelines.
Exact Sciences will also share real-world evidence showing high
adherence and three-year repeat rate of the Cologuard test. It will
also share data demonstrating success with using different digital
outreach approaches to help improve screening adherence, leading to
high screening completion rates for the Cologuard test across
different patient populations.
Data presentations across Exact Sciences' Precision Oncology
and Screening portfolio at ASCO 2024:
Precision Oncology
Abstract 515: Recurrence Score® Gene Axes Scores by Race and
Ethnicity in the RxPONDER Trial Presenter: Y. Abdou, MD
Session: Rapid Oral Abstract Session Date/time:
Friday, May 31, 3:39 PM – 3:45 PM CDT Key findings: This study
analyzed Recurrence Score gene axis scores and their associations
with outcomes to understand the differences in underlying tumor
biology among different racial and ethnic groups. Recurrence Score
gene axis scores differed by race/ethnicity, with Non-Hispanic
Black patients exhibiting higher proliferation axis scores than
other groups. This could partially explain the poorer outcomes
observed in this population in the RxPONDER trial. These findings
highlight the importance of tumor biology and support further
investigation into the intricate factors contributing to
disparities in outcomes to address them effectively.
Abstract 533/Poster Bd 125: Updated SEER database study of
21-gene assay to assess breast cancer-specific mortality and
benefit of chemotherapy by race and ethnicity Presenter:
E. Diego, MD Session: Poster Session Date/time:
Sunday, June 2, 9:00 AM CDT Location: Hall A Key findings:
Real-world evidence from the SEER registries in over 145,000
patients with breast cancer confirms that the Oncotype DX Breast
Recurrence Score test is prognostic of breast cancer-specific
survival across all racial and ethnic groups and predictive of
chemotherapy benefit across most groups. This study was performed
to further understand the racial and ethnic disparities identified
in the TAILORx and RxPONDER phase 3 trials, which used the Oncotype
DX test to identify patients with node-negative or node-positive
breast cancer who may or may not benefit from chemotherapy. This
latest SEER analysis provides further confidence in the prognostic
value of the Oncotype DX test regardless of race or ethnicity.
Abstract 508: Development and validation of RSClin N+ tool
for hormone receptor-positive (HR+), HER2-negative (HER2-)
node-positive breast cancer Presenter: L. Pusztai, MD,
PhD, FASCO Session: Oral Abstract Session Date/time:
Monday, June 3, 5:24 PM – 5:35 PM CDT Location: Hall B1 Key
findings: The RSClin® N+ tool model delivers improved estimates of
prognostic risk and absolute chemoendocrine therapy benefit over
clinical or genomic data alone for patients with node-positive,
HR+/HER2- breast cancer and could be used in patient counseling.
Building upon the success of the RSClin tool, the N+ version of the
RSClin tool integrates the Recurrence Score result with
clinicopathologic factors, stratified by menopausal status, to
further enhance its prognostic and predictive value for patients
with node-positive disease.
Abstract 576/Poster Bd 168: Evaluating Ki67 and Oncotype DX
Recurrence Score during neoadjuvant treatment with
letrozole/abemaciclib or chemotherapy in highly proliferative
HR+/HER2- breast cancer patients participating in the GEICAM
CARABELA trial. Presenter: A. Guerrero, MD
Session: Poster Session Date/time: Sunday, June 2,
9:00 AM CDT Location: Hall A Key findings: Highly
proliferative breast cancer tumors (Ki67 ≥40%) or those with high
Recurrence Score results (>25) showed lower residual cancer
burden after neoadjuvant chemotherapy treatment versus neoadjuvant
letrozole plus abemaciclib. These data confirm the predictive value
of Ki67 and Recurrence Score risk assessments and suggest that
relying solely on letrozole/abemaciclib as a systemic treatment for
these tumors may be insufficient. This is an exploratory analysis
from the CARABELA phase 2 trial, which is comparing the efficacy of
neoadjuvant chemotherapy vs. neoadjuvant letrozole/abemaciclib
treatment in patients with HR+/HER2- breast cancer who are at
high/intermediate risk (stage II-III, Ki67≥20%).
Abstract 565: Combination of predicted sensitivity to
endocrine therapy (SET2,3 index) and the Recurrence Score® in
node-positive breast cancer: independent validation in the PACS-01
trial Presenter: F.M. Penault-Llorca, MD, PhD
Session: Poster Session Date/time: Sunday, June 2,
9:00 AM CDT Location: Hall A Key findings: Combining the
Oncotype DX Breast Recurrence Score test with the Sensitivity to
Endocrine Therapy (SET2,3) index, a biomarker-based assessment
designed to assess a tumor's response to hormonal therapy,
successfully enhanced the prognostic value for patients with
node-positive breast cancer. These are data from an independent,
blinded validation analysis of the PACS-01 trial, which evaluated
sequential adjuvant epirubicin-based and docetaxel chemotherapy for
patients with node-positive breast cancer.
Abstract 10584/Poster Bd 111: Clinical and economic benefit
of genomic testing strategies to guide the treatment of patients
with HR+/HER2- breast cancer in the US Presenter: B.
Heald, MS Session: Poster Session Date/time: Monday,
June 3, 1:30 PM CDT Location: Hall A Key findings: Using a
testing strategy that combines both the Oncotype DX Breast
Recurrence Score test and germline genetic testing (GGT), which
identifies potentially pathogenic cancer variants, can help
optimize treatment decisions in early HR+/HER2- breast cancer and
improve patient outcomes at reduced costs, according to this health
economic modeling study.
Screening
Abstract 11135/Poster Bd 330: Time-to-diagnosis and
peri-diagnostic healthcare utilization between screen- and
non-screen detected cancers: Evidence from SEER-Medicare
Presenter: X. Cao, PhD Session: Poster Session
Date/time: Monday, June 3, 9:00 AM CDT Location: Hall
A Key findings: Effective cancer screening programs successfully
shortened the time to diagnosis and reduced the frequency of stage
4 diagnoses for patients with breast or colorectal cancer detected
through screening. This retrospective SEER registry analysis
reinforces that effective cancer screening technologies have the
potential to improve patient outcomes by enabling earlier detection
when treatment options are typically most successful.
Abstract 11076/ Poster Bd 271: Effect of multi-cancer early
detection testing on late-stage cancers: A modeling study
Presenter: J. Chhatwal, PhD Session: Poster Session
Date/time: Monday, June 3, 9:00 AM CDT Location: Hall
A Key findings: In a 50-year modeling simulation, MCED testing
resulted in 1,323 fewer Stage IV (24%) cancer diagnoses overall
compared to usual care. Thirty-eight percent of these Stage IV
reductions were attributable to screening for cancers without
recommended guidelines, underscoring the potential of novel MCED
strategies to help catch cancers earlier and initiate treatment
interventions sooner.
Abstract e15632: Real-world multi-target stool DNA adherence
in an underserved and vulnerable prison patient population.
Presenter: J. Kasselman Session: Publication Only
Date/time: N/A Location: N/A Key findings: Among
incarcerated persons, mt-sDNA yielded high adherence rates (95.3%)
and short completion times (average of 20 days) in this
difficult-to-reach population. These data further demonstrate the
importance of efforts to uncover patient, provider, and
system-level benefits that may be obtained through broader adoption
of this highly accessible screening approach in this challenging
healthcare setting.
Abstract e15633: Real-world multi-target stool DNA
longitudinal adherence for colorectal cancer re-screening in a
large, national population Presenter: M. Greene
Session: Publication Only Date/time: N/A
Location: N/A Key findings: In a real-world longitudinal
analysis of 481,748 patients, adherence to repeat colorectal cancer
(CRC) screening with the Cologuard test remained high (83.6%), and
patients who underwent repeat screening once were more likely to
continue with a third lifetime Cologuard screening. These data
suggest high perceived patient confidence in Cologuard, further
reinforcing its potential to help close the CRC screening gap for
average-risk individuals.
About Exact Sciences’ Precision Oncology portfolio
Exact Sciences’ Precision Oncology portfolio delivers actionable
genomic insights to inform prognosis and cancer treatment after a
diagnosis. In breast cancer, the Oncotype DX Breast Recurrence
Score® test is the only test shown to predict the likelihood of
chemotherapy benefit as well as recurrence in invasive breast
cancer. The Oncotype DX® test is recognized as the standard of care
and is included in all major breast cancer treatment guidelines.
The OncoExTra® test applies comprehensive tumor profiling,
utilizing whole exome and whole transcriptome sequencing, to aid in
therapy selection for patients with advanced, metastatic,
refractory, relapsed, or recurrent cancer. With an extensive panel
of approximately 20,000 genes and 169 introns, the OncoExTra test
is one of the most comprehensive genomic (DNA) and transcriptomic
(RNA) panels available today. The Riskguard™ hereditary cancer test
provides an individualized patient report that includes
gene-specific and familial risks using a simple blood or saliva
sample for 10 common cancers: colorectal, breast, prostate, skin,
ovarian, endometrial, pancreatic, gastric, kidney, and endocrine.
Exact Sciences enables patients to take a more active role in their
cancer care and makes it easy for providers to order tests,
interpret results, and personalize medicine. To learn more, visit
precisiononcology.exactsciences.com.
About Cologuard
The Cologuard test was approved by the FDA in August 2014, and
results from Exact Sciences’ prospective 90-site, point-in-time,
10,000-patient pivotal trial were published in The New England
Journal of Medicine in March 2014. The Cologuard test is included
in the American Cancer Society’s (2018) colorectal cancer screening
guidelines and the recommendations of the U.S. Preventive Services
Task Force (2021) and National Comprehensive Cancer Network (2016).
The Cologuard test is indicated to screen adults 45 years of age
and older who are at average risk for colorectal cancer by
detecting certain DNA markers and blood in the stool. Do not use
the Cologuard test if you have had precancer, have inflammatory
bowel disease and certain hereditary syndromes, or have a personal
or family history of colorectal cancer. The Cologuard test is not a
replacement for colonoscopy in high-risk patients. The Cologuard
test performance in adults ages 45-49 is estimated based on a large
clinical study of patients 50 and older. The Cologuard test
performance in repeat testing has not been evaluated.
The Cologuard test result should be interpreted with caution. A
positive test result does not confirm the presence of cancer.
Patients with a positive test result should be referred for
colonoscopy. A negative test result does not confirm the absence of
cancer. Patients with a negative test result should discuss with
their doctor when they need to be tested again. Medicare and most
major insurers cover the Cologuard test. For more information about
the Cologuard test, visit cologuardtest.com. Rx only.
About Exact Sciences Corp.
A leading provider of cancer screening and diagnostic tests,
Exact Sciences gives patients and healthcare professionals the
clarity needed to take life-changing action earlier. Building on
the success of the Cologuard® and Oncotype® tests, Exact Sciences
is investing in its pipeline to develop innovative solutions for
use before, during, and after a cancer diagnosis. For more
information, visit ExactSciences.com, follow Exact Sciences on X
(formerly known as Twitter) @ExactSciences, or find Exact Sciences
on LinkedIn and Facebook. NOTE: Exact Sciences and Cologuard are
trademarks or registered trademarks of Exact Sciences Corporation.
Oncotype, Oncotype DX, Oncotype DX Breast Recurrence Score, RSClin,
and Recurrence Score are trademarks or registered trademarks of
Genomic Health, Inc. All other trademarks and service marks are the
property of their respective owners. Cologuard is not available
outside of the U.S. Exact Sciences’ multi-cancer early detection
test is still in development.
Forward-Looking Statements
This news release contains forward-looking statements concerning
our expectations, anticipations, intentions, beliefs or strategies
regarding the future. These forward-looking statements are based on
assumptions that we have made as of the date hereof and are subject
to known and unknown risks and uncertainties that could cause
actual results, conditions and events to differ materially from
those anticipated. Therefore, you should not place undue reliance
on forward-looking statements. Examples of forward-looking
statements include, among others, statements we make regarding
expectations for development and commercialization of new or
improved products and services and their impacts on patients, and
our strategies, positioning, resources, capabilities and
expectations for future events or performance. Risks and
uncertainties that may affect our forward-looking statements are
described in the Risk Factors sections of our most recent Annual
Report on Form 10-K and any subsequent Quarterly Reports on Form
10-Q, and in our other reports filed with the Securities and
Exchange Commission. 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20240524972270/en/
Media (U.S.): Gisela Pedroza +1 949 468-7854
gpedroza@exactsciences.com
Media (OUS): Federico Maiardi +41 79-138-1326
fmaiardi@exactsciences.com
Investors: Nathan Harrill +1 608 535-8659
investorrelations@exactsciences.com
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