Sanofi partnering with leading academic cooperative groups to study
amcenestrant in the adjuvant setting for patients with estrogen
receptor positive breast cancer
Sanofi
partnering with
leading academic cooperative groups
to study
amcenestrant in the
adjuvant setting for patients with estrogen
receptor positive breast cancer
- Sanofi partnering with the Breast International Group (BIG),
the European Organization for Research and Treatment of Cancer
(EORTC) and Alliance Foundation Trials (AFT), which are
world-leading academic groups delivering practice-changing breast
cancer clinical research
- Collaborating on the Phase 3 AMEERA-6 study expected to be the
first pivotal trial of an oral selective estrogen receptor degrader
(SERD) in the adjuvant setting and will evaluate the safety and
efficacy of Sanofi’s investigational amcenestrant in estrogen
receptor-positive (ER+) patients who prematurely discontinue
standard therapy and have high risk of disease recurrence
- Parties to finalize full terms of this cooperative effort
- Additional treatment options in early breast cancer are needed
to help prevent patients from developing advanced, incurable
disease and would represent a significant treatment advance
PARIS – June
4, 2021 – 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
TrialsAlliance 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 CancerEuropean 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
GroupThe 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
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Sanofi is transforming scientific innovation into healthcare
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(781) 264-1091Sally.Bain@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.
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