Press Release: Sanofi provides update on amcenestrant clinical development program
17 Agosto 2022 - 7:30AM
Press Release: Sanofi provides update on amcenestrant clinical
development program
Sanofi provides update on amcenestrant clinical
development program
PARIS,
August 17, 2022.
Sanofi is discontinuing the global clinical development program of
amcenestrant, an investigational oral selective estrogen receptor
degrader (SERD). The decision is based on the outcome of a
prespecified interim analysis of the Phase 3 AMEERA-5 trial
evaluating amcenestrant in combination with palbociclib compared
with letrozole in combination with palbociclib in patients with
estrogen receptor-positive (ER+)/human epidermal growth factor
receptor 2-negative (HER2-) advanced breast cancer.
An Independent Data Monitoring Committee (IDMC)
found that amcenestrant in combination with palbociclib did not
meet the prespecified boundary for continuation in comparison with
the control arm and recommended stopping the trial. No new safety
signals were observed. Trial participants will be transitioned to
letrozole in combination with palbociclib or another appropriate
standard of care therapy, as determined by their physician.
The company will continue to review the data and
plans to share the results with the scientific community in the
future. All other studies of amcenestrant, including in early-stage
breast cancer (AMEERA-6), will be discontinued.
John Reed, MD,
PhDGlobal Head of Research and Development at Sanofi“While
we are disappointed by this outcome, our research will further the
scientific understanding of endocrine therapies in people with
breast cancer. Our sincere gratitude goes to the patients, families
and healthcare professionals involved in the amcenestrant clinical
development program. Oncology remains a priority area for Sanofi,
and we will continue to pursue transformative research to develop
new medicines for people living with cancer.”
In March, Sanofi announced that the Phase 2
AMEERA-3 trial had not met the primary endpoint of improving
progression-free survival in patients with ER+/HER2- advanced or
metastatic breast cancer.
About AMEERA-5AMEERA-5 is a randomized,
double-blind Phase 3 trial evaluating the efficacy and safety of
amcenestrant in combination with palbociclib, a CDK4/6 inhibitor,
in the first-line treatment of patients with ER+/HER2- advanced
breast cancer. A total of 1068 patients who had not received any
prior systemic anticancer therapies for advanced disease were
randomized 1:1 to receive either amcenestrant or letrozole in
combination with palbociclib.
About AMEERA-6AMEERA-6 is a randomized,
double-blind Phase 3 trial evaluating the efficacy and safety of
amcenestrant compared with tamoxifen in patients with hormone
receptor-positive early breast cancer who have discontinued
adjuvant aromatase inhibitor (AI) therapy due to treatment related
toxicity. The trial was initiated in partnership with the Breast
International Group (BIG), the European Organization for Research
and Treatment of Cancer (EORTC), and the Alliance Foundation Trials
(AFT).
About SanofiWe are an innovative global
healthcare company, driven by one purpose: we chase the miracles of
science to improve people’s lives. Our team, across some 100
countries, is dedicated to transforming the practice of medicine by
working to turn the impossible into the possible. We provide
potentially life-changing treatment options and life-saving vaccine
protection to millions of people globally, while putting
sustainability and social responsibility at the center of our
ambitions.
Sanofi is listed on EURONEXT: SAN and NASDAQ:
SNY
Media RelationsEvan
Berland| + 1 215 432 0234
| evan.berland@sanofi.comKate Conway | +1 508
364 4931 | kate.conway@sanofi.com
Investor RelationsEva
Schaefer-Jansen | + 33 7 86 80 56 39
| eva.schaefer-jansen@sanofi.comArnaud
Delépine | + 33 6 73 69
36 93 | arnaud.delepine@sanofi.comCorentine
Driancourt | + 33 6 40 56 92 21 |
corentine.driancourt@sanofi.comFelix
Lauscher | + 1 908 612 7239 |
felix.lauscher@sanofi.comPriya
Nanduri | + 1 617 764 6418 |
priya.nanduri@sanofi.com Nathalie
Pham | + 33 7 85 93 30 17 |
nathalie.pham@sanofi.com
Disclaimers or Forward-Looking
StatementsThis press release contains forward-looking
statements as defined in the Private Securities Litigation Reform
Act of 1995, as amended. Forward-looking statements are statements
that are not historical facts. These statements include projections
and estimates and their underlying assumptions, statements
regarding plans, objectives, intentions and expectations with
respect to future financial results, events, operations, services,
product development and potential, and statements regarding future
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“estimates”, “plans” and similar expressions. Although Sanofi’s
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forward-looking statements are reasonable, investors are cautioned
that forward-looking information and statements are subject to
various risks and uncertainties, many of which are difficult to
predict and generally beyond the control of Sanofi, that could
cause actual results and developments to differ materially from
those expressed in, or implied or projected by, the forward-looking
information and statements. These risks and uncertainties include
among other things, the uncertainties inherent in research and
development, future clinical data and analysis, including post
marketing, decisions by regulatory authorities, such as the FDA or
the EMA, regarding whether and when to approve any drug, device or
biological application that may be filed for any such product
candidates as well as their decisions regarding labelling and other
matters that could affect the availability or commercial potential
of such product candidates, the fact that product candidates if
approved may not be commercially successful, the future approval
and commercial success of therapeutic alternatives, Sanofi’s
ability to benefit from external growth opportunities, to complete
related transactions and/or obtain regulatory clearances, risks
associated with intellectual property and any related pending or
future litigation and the ultimate outcome of such litigation,
trends in exchange rates and prevailing interest rates, volatile
economic and market conditions, cost containment initiatives
and subsequent changes thereto, and the impact that COVID-19
will have on us, our customers, suppliers, vendors, and other
business partners, and the financial condition of any one of them,
as well as on our employees and on the global economy as a
whole. Any material effect of COVID-19 on any of the
foregoing could also adversely impact us. This situation is
changing rapidly and additional impacts may arise of which we are
not currently aware and may exacerbate other previously identified
risks. The risks and uncertainties also include the uncertainties
discussed or identified in the public filings with the SEC and the
AMF made by Sanofi, including those listed under “Risk Factors” and
“Cautionary Statement Regarding Forward-Looking Statements” in
Sanofi’s annual report on Form 20-F for the year ended December 31,
2021. Other than as required by applicable law, Sanofi does not
undertake any obligation to update or revise any forward-looking
information or statements.
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