New Data Presented at SABCS 2022 Reveal Expanded Predictive Value of the Breast Cancer Index™ Test for Ovarian Function Suppression in Premenopausal Women with HR+ Breast Cancer
December 06 2022 - 4:04PM
Business Wire
The Breast Cancer Index Test Is the First
Biomarker to Predict Treatment Benefit in the SOFT Trial
Hologic, Inc. (Nasdaq: HOLX) and its subsidiary,
Biotheranostics, Inc., today announced new study data showing that
the Breast Cancer Index test identified which premenopausal
patients with early-stage, hormone-receptor positive (HR+) breast
cancer benefited from the addition of ovarian function suppression
(OFS) to primary adjuvant endocrine therapy. The Breast Cancer
Index test is the first biomarker to be evaluated in a cohort from
the landmark Suppression of Ovarian Function Trial (SOFT). The
translational study results are featured in the official press
program at the 2022 San Antonio Breast Cancer Symposium (SABCS)
being held from December 6-10, 2022.1 Full study results were
presented during the general session #GS1-06 on December 6 at 3:15
p.m. CST.
“There is a significant need for biomarkers to aid in treatment
decisions for premenopausal women with breast cancer. Our study
presented at SABCS is the first to examine a biomarker’s ability to
determine benefit of ovarian function suppression in these women,”
said Dr. Ruth O’Regan, Chair of Medicine and Charles A. Dewey
Professor at the University of Rochester. “These data found that
the Breast Cancer Index test identified women who received benefit
from ovarian function suppression as well as those who did not,
which is incredibly important given the potential impact of this
more intensive treatment approach in young women. While these data
are promising, we look forward to further investigating the test’s
utility to help inform ovarian function suppression treatment
decisions in the future.”
The landmark SOFT trial was an international, three-arm,
non-blinded, randomized clinical trial of 3,066 premenopausal women
with HR+ breast cancer. The trial demonstrated that the addition of
OFS to five years of primary adjuvant endocrine therapy (either
tamoxifen or exemestane) reduced the risk of recurrence compared to
adjuvant tamoxifen alone.2 OFS typically involves hormonal drug
injections with a gonadotropin-releasing hormone (GnRH) agonist or
surgical removal of the ovaries (bilateral oophorectomy).3 In an
effort to evaluate the potential of a biomarker to assist in
patient selection for this more intensive approach, the new study
presented at SABCS evaluated the predictive and prognostic ability
of the Breast Cancer Index test in a cohort of patient tumor
samples (n=1,717) from the SOFT trial. Notably, the patient
characteristics in this retrospective translational study were
highly representative of the original SOFT trial.
The data found that the Breast Cancer Index genomic assay
identified which premenopausal women with early-stage, HR+ breast
cancer benefited from more intensive endocrine therapy (exemestane
plus OFS) compared to tamoxifen alone. The Breast Cancer Index test
identified 58% of women who benefited from the addition of OFS,
experiencing an absolute benefit of 11.6%, compared with 42% who
did not benefit (p<0.01 in adjusted analysis). The data also
found that the Breast Cancer Index test’s predictive performance
was generally consistent across subgroups, including nodal status,
prior chemotherapy, age and HER2-negative patients. Compared to the
benefit shown with exemestane plus OFS versus tamoxifen alone, the
benefit for tamoxifen plus OFS versus tamoxifen alone was smaller,
which is consistent with data reported from the SOFT trial itself.
The study also confirmed the prognostic value of the Breast Cancer
Index test, as women with higher Breast Cancer Index test risk
scores were more likely to experience disease recurrence.
“Multiple clinical studies and national oncology guidelines
affirm the predictive ability of the Breast Cancer Index test for
extended endocrine therapy,” said Kevin Thornal, Group President,
Global Diagnostic Solutions at Hologic. “These new data further
establish the Breast Cancer Index test as a significant endocrine
response biomarker and reveal additional predictive capabilities of
the test. As we explore its predictive power earlier in a patient’s
journey, we aim to uncover broader potential clinical utility in
more women with early-stage, HR+ breast cancer.”
About the Breast Cancer Index Test
The Breast Cancer Index test is a molecular, gene
expression-based test uniquely positioned to provide information to
help physicians individualize treatment decisions for patients with
early-stage, HR+ breast cancer. This breakthrough test helps
oncologists and patients navigate the difficult trade-offs between
taking steps to prevent recurrence of their disease and facing
significant side effects and safety challenges related to
unnecessary treatment. The Breast Cancer Index test has guideline
designation from the American Joint Committee on Cancer for cancer
staging based on molecular profile. The American Society of
Clinical Oncology (ASCO), the European Group on Tumor Markers
(EGTM) and St. Gallen acknowledge the Breast Cancer Index test as a
biomarker to inform the chemotherapy decision; and ASCO, EGTM and
the NCCN Clinical Practice Guidelines in Oncology (NCCN
Guidelines®) acknowledge the Breast Cancer Index test as a
biomarker to inform the extended endocrine treatment decision.4 It
is the only validated, commercially available test that predicts
benefit from extended endocrine therapy. The Breast Cancer Index
test is intended for routine clinical use, and treatment decisions
based on results are the responsibility of the physician. It is a
laboratory developed test (LDT) performed in a single
CLIA-certified and CAP-accredited diagnostic laboratory and is not
required to be cleared or approved by the U.S. Food and Drug
Administration. For more information, visit
www.breastcancerindex.com.
About Hologic, Inc.
Hologic, Inc. is a global medical technology innovator primarily
focused on improving women’s health and well-being through early
detection and treatment. Its advancements include invention of the
world’s first commercial 3D mammography system to fight breast
cancer; leadership in testing for cervical cancer, sexually
transmitted infections, respiratory illnesses, and the virus that
causes COVID-19; and minimally invasive surgical technologies for
uterine fibroids and abnormal uterine bleeding.
The company also champions women through the Hologic Global
Women’s Health Index, which provides a science-backed data roadmap
for improving women’s well-being, and Project Health Equality,
which elevates awareness, research insights and access to quality
care for underserved women.
Hologic, Breast Cancer Index, The Science of Sure and associated
logos are trademarks and/or registered trademarks of Hologic, Inc.
and/or its subsidiaries in the United States and/or other
countries.
Forward-Looking Statements
This press release may contain forward-looking information that
involves risks and uncertainties, including statements about the
use of the Breast Cancer Index test. There can be no assurance that
this test will achieve the benefits described herein or that such
benefits will be replicated in any particular manner with respect
to an individual patient. The actual effect of the use of the test
can only be determined on a case-by-case basis depending on the
particular circumstances and patient in question. In addition,
there can be no assurance that the test will be commercially
successful or achieve any expected level of sales. Hologic
expressly disclaims any obligation or undertaking to publicly
release any updates or revisions to any such statements presented
herein to reflect any change in expectations or any change in
events, conditions or circumstances on which any such statements
are based.
References
1. https://www.sabcs.org/Program/Schedule-at-a-Glance. Accessed
November 10, 2022. 2.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4341825/. Accessed
November 10, 2022. 3.
https://www.hopkinsmedicine.org/kimmel_cancer_center/cancers_we_treat/breast_cancer_program/treatment_and_services/survivorship/endocrine_therapy/premenopausal_women.html.
Accessed November 10, 2022. 4. Referenced with permission from the
NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®)
for Breast Cancer V.4.2022. © National Comprehensive Cancer
Network, Inc. 2022. All rights reserved. Accessed November 10,
2022. To view the most recent and complete version of the
guideline, go online to NCCN.org. NCCN makes no warranties of any
kind whatsoever regarding their content, use or application and
disclaims any responsibility for their application or use in any
way.
Source: Hologic, Inc.
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version on businesswire.com: https://www.businesswire.com/news/home/20221206005354/en/
Media Contact: Jane Mazur Vice President, Global
Communications (+1) 585.355.5978 jane.mazur@hologic.com
Investor Contact: Ryan Simon Vice President, Investor
Relations (+1) 858.410.8514 ryan.simon@hologic.com
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