PARIS, June 4, 2021 /PRNewswire/ -- Sanofi is partnering
with leading groups delivering practice-changing breast cancer
research, the Breast International Group (BIG), the European
Organization for Research and Treatment of Cancer (EORTC) and the
Alliance Foundation Trials (AFT), to initiate a pivotal trial of an
oral selective estrogen receptor degrader (SERD) in the adjuvant
setting. The Phase 3 AMEERA-6 study will evaluate the efficacy and
safety of Sanofi's amcenestrant vs tamoxifen for women with
estrogen receptor-positive (ER+) breast cancer who were unable to
continue their adjuvant aromatase inhibitor (AI) therapy.
"Together with our research partners, BIG conducts landmark,
practice-changing trials that can have a significant impact on the
lives of women with breast cancer," said David Cameron, Chair of the BIG Executive
Board. "Adjuvant therapy helps prevent and delay the
progression of disease into the later setting. However, current
adjuvant therapies, like AIs, can have side effects for some women,
which may cause them to discontinue the medication prematurely.
Amcenestrant may be a potential option for women in this setting
and we look forward to working with Sanofi, EORTC and AFT to
investigate this further."
"We look forward to collaborating with these leading academic
networks to investigate amcenestrant in the adjuvant setting
through AMEERA-6. Based on encouraging data emerging from our
ongoing clinical program, we believe that amcenestrant, an
investigational oral SERD, has the potential to become a
best-in-class oral endocrine backbone therapy," said Peter Adamson, M.D., Global Development Head,
Oncology at Sanofi. "Additional treatment options for patients
with breast cancer are needed to allow women to remain on adjuvant
therapy and decrease their risk of progressive disease."
Amcenestrant is an oral SERD that antagonizes and degrades the
estrogen receptor (ER), resulting in inhibition of the ER signaling
pathway. Amcenestrant is currently under clinical
investigation and its safety and efficacy have not been evaluated
by any regulatory authority.
Despite the established clinical efficacy of tamoxifen and AIs
in early breast cancer, many patients experience disease recurrence
because of resistance to therapy, non-adherence or premature
discontinuation of their adjuvant
therapy.1 Additional treatment options in the
adjuvant setting in early breast cancer are needed to prevent women
from developing advanced, incurable disease and could represent a
significant treatment advance.
As per the terms of the Pre-Study Agreement, Sanofi will be the
sponsor and will provide funding and investigational drug product
for the global study. BIG will conduct the study within the BIG
network, EORTC will oversee study management and data analysis, as
well as the medical management, and AFT will conduct the United States portion of the study. Sanofi
will conduct this global study in selected countries outside the
geographical scope of the academic networks, as further described
in a follow-on agreement under negotiation among the four parties.
The protocol is being developed in collaboration with all four
parties, including AFT, BIG, EORTC and Sanofi.
About Alliance Foundation Trials
Alliance Foundation
Trials, LLC (AFT) is a research organization that develops and
conducts cancer clinical trials, working closely with the Alliance
for Clinical Trials in Oncology scientific investigators and
institutional member network, research collaborators, and non-NCI
funding sources. AFT seeks to fulfil the vision of the Alliance for
Clinical Trials in Oncology to reduce the impact of cancer on
people by uniting a broad community of scientists and clinicians
from many disciplines committed to discovering, validating, and
disseminating effective strategies for the prevention and treatment
of cancer. Current AFT studies are funded by a number of
pharmaceutical company collaborators and the Patient-Centered
Outcomes Research Institute (PCORI).
To learn more about AFT studies, visit
www.AllianceFoundationTrials.org.
About European Organization for Research and Treatment of
Cancer
European Organization for the Research and Treatment
of Cancer (EORTC) is an academic clinical research organisation
which unites clinical cancer research experts across the globe to
define better treatments for cancer patients to prolong survival
and improve quality of life. Both international and
multidisciplinary, EORTC's Network comprises over 2800
collaborators involved in cancer treatment and research in more
than 740 institutions across 30 countries. Conducting translational
research, phase 2 and 3 trials, EORTC offers an integrated approach
to therapeutic strategies and quality of life. EORTC Headquarters,
a unique international clinical research infrastructure, is based
in Brussels, Belgium, from where
its various activities are coordinated and run.
For further information, please visit the EORTC
website: www.eortc.org.
About Breast International Group
The Breast
International Group (BIG) is an international not-for-profit
organization for academic breast cancer research groups from around
the world, based in Brussels,
Belgium.
Global collaboration is crucial to make significant advances in
breast cancer research, reduce unnecessary duplication of effort,
share data, contribute to the faster development of better
treatments, and increase the likelihood of cures for patients.
Therefore, BIG facilitates breast cancer research at the
international level, by stimulating cooperation between its members
and other academic networks, and collaborating with, but working
independently from, the pharmaceutical industry.
In 1999, BIG was founded by leading European opinion leaders
with the aim to address fragmentation in European breast cancer
research. Research groups from other parts of the world rapidly
expressed interest in joining BIG and, two decades later, BIG
represents a network of over 50 like-minded research groups from
around the world. These entities are tied to several thousand
specialized hospitals, research centres and world class breast
cancer experts across approximately 70 countries on 6 continents.
More than 30 clinical trials are run or are under development under
the BIG umbrella at any one time. BIG also works closely with the
US National Cancer Institute (NCI) and the NCI National Clinical
Trials Network (NCTN), so that together they act as a strong
integrating force in the breast cancer research arena.
BIG's research is supported in part by its philanthropy unit,
known as BIG against breast cancer. This denomination is
used to interact with the general public and donors, and to raise
funds for BIG's purely academic breast cancer trials and research
programs. BIG against breast cancer conducts vital fundraising to
help finance academic clinical trials and research programs that
have no commercial interest but are crucial for patients with
breast cancer. The funds raised provide the means for BIG's member
groups (made up of breast cancer experts across the globe), and
their affiliated hospitals, to finance their efforts and patients'
participation in one or more BIG studies. Between 2012 and 2020,
94.4% of all funds BIG received, including from BIG against breast
cancer's philanthropic activity, were spent directly on BIG's
research.
For further information, please visit the BIG website:
www.bigagainstbc.org, or contact Oriana
Spagnolo, Communications Manager (Tel: +32 479 814831,
Email: communications@bigagainstbc.org).
About Sanofi
Sanofi is dedicated to supporting people through their health
challenges. We are a global biopharmaceutical company focused on
human health. We prevent illness with vaccines, provide innovative
treatments to fight pain and ease suffering. We stand by the few
who suffer from rare diseases and the millions with long-term
chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is
transforming scientific innovation into healthcare solutions around
the globe.
Sanofi, Empowering Life
Sanofi Media
Relations Contact Sally Bain Tel: +1 781-264-1091 Sally.Bain@sanofi.com
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Relations Contacts Paris Eva Schaefer-Jansen Arnaud Delepine Nathalie Pham
Sanofi Investor
Relations Contacts North America Felix Lauscher Fara Berkowitz Suzanne Greco
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line: Tel: +33 (0)1 53 77
45 45 investor.relations@sanofi.com
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1 Murphy CC, Bartholomew LK, Carpentier MY,
Bluethmann SM, Vernon SW. Adherence to adjuvant hormonal therapy
among breast cancer survivors in clinical practice: a systematic
review. Breast Cancer Res Treat. 2012;134(2):459-78.
Source: Sanofi (EURONEXT: SAN) (NASDAQ: SNY)
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