Sanofi
takes stock of
the phase II study evaluating the
amcenestrant
in the treatment of breast cancer
ER+/HER2-
at an advanced or metastatic stage
The AMEERA-3 trial failed to meet its primary endpoint – no improvement in progression-free survival.
Ongoing trials, including AMEERA-5 and AMEERA-6, are continuing as planned.
Paris,
the
14
March
2022
. The Phase II AMEERA-3 clinical trial evaluating amcenestrant, an oral optimized experimental selective estrogen receptor deregulator (SERD), failed to meet its primary endpoint of improvement in progression-free survival, as determined by independent central review. The trial evaluated amcenestrant as monotherapy, compared to an endocrine therapy chosen by the physician, in patients with advanced or metastatic estrogen receptor positive (ER+)/receptor 2 negative breast cancer of human epidermal growth factor (HER2-), which progressed during or after hormonal treatments. No new safety signals were identified and the safety profile of amcenestrant in the AMEERA-3 trial was consistent with that observed in previous studies.
Dr.
John Reed
,
Ph
.
D
.
Global Head, Research and Development of Sanofi
”
This test of p
base
He assessed
I’
at
mcenestrant
in
monotherapy
in patients with advanced breast cancer
which have a limited number of treatment options. Although we are
We are disappointed with the results of
AMEERA-3
,
we continue to study the
amcenestrant
in patients with early stage breast cancer
with different tumor profiles and
under different reference treatments. »
Sanofi will continue to evaluate data from the AMEERA-3 trial and work with investigators to publish its full results. The ongoing clinical trial program for amcenestrant continues as planned, including the AMEERA-5 and AMEERA-6 trials.
Amcenestrant is an orally optimized SERD that binds to estrogen receptors (ER) of breast cancer cells to inhibit their normal function and cause them to be broken down so that they can no longer be used by breast cancer cells. tumor cells for their growth. Amcenestrant is currently undergoing clinical trials and no regulatory body has yet evaluated its safety and efficacy profiles.
About the trial
AMEERA-3
AMEERA-3 was a phase II, randomized, open-label study evaluating amcenestrant monotherapy, compared with endocrine monotherapy of physician’s choice, in patients with locally advanced or metastatic estrogen receptor-positive breast cancer (ER+) and HER2 negative, having received previous hormonal treatments. The primary objective of the AMEERA-3 study was to determine whether amcenestrant improves progression-free survival, compared to endocrine monotherapy, according to an independent central evaluation. The primary secondary endpoint was overall survival and the other secondary endpoints were objective response rate, disease control rate, clinical benefit and duration of response. A comparison of the overall safety profile between the two treatment groups was also performed as part of the study, as well as an assessment of the health-related quality of life, based on the results reported by the patient.
About the clinical program dedicated to
amcenestrant
The comprehensive development program of amcenestrant was designed to evaluate its potential as an oral disease-modifying endocrine therapy in different settings and, in particular, as monotherapy for the treatment of 2
th
line or following lines of metastatic ER+/HER2- (AMEERA-3) breast cancer, in combination with palbociclib for the treatment of 1
time
ER+/HER2- metastatic breast cancer line (AMEERA-5), as well as to assess its potential in the treatment of early stage breast cancer in an adjuvant setting (AMEERA-6). Enrollment in the AMEERA-5 Phase III clinical trial, launched in late 2020, is complete. Enrollment in the AMEERA-6 Phase III trial, conducted in partnership with the Breast International Group (BIG), the European Organization for Research and Treatment of Cancer (EORTC) and the Alliance Foundation Trials (AFT), is in progress.
For more information about clinical trials of amcenestrant, see www.clinicaltrials.gov.
About
Sanofi
We are an innovative, global health company driven by one purpose: to pursue the miracles of science to improve people’s lives. Our teams, present in a hundred countries, are working to transform the practice of medicine to make the impossible possible. We provide therapeutic solutions that can change the lives of patients and vaccines that protect millions of people around the world, guided by the ambition of sustainable development and our social responsibility.
Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY.
Relationships
media
Sandrine Guendoul
| + 33 6 25 09 14 25 |
Nicholas Obrist
| + 33 6 77 21 27 55 |
Relationships
investors
Eva Schaefer-Jansen
| + 33 7 86 80 56 39 | [email protected]
Arnaud
Delepine
| + 33 6 73 69 36 93 | [email protected]
Corentina
Driancourt
| + 33 6 40 56 92 21 | [email protected]
Felix Lauscher
| + 1 908 612 7239 | [email protected]
Priya Nanduri
| +1 908 981 5560 | [email protected]
Nathalie Pham
| + 33 7 85 93 30 17 | [email protected]
Forward-looking statements
This press release contains forward-looking statements. These statements do not constitute historical facts. These statements include projections and estimates and the assumptions on which they are based, statements relating to plans, objectives, intentions and expectations regarding financial results, events, operations, future services, product development and their potential or future performance. These forward-looking statements can often be identified by the words “expect”, “anticipate”, “believe”, “intend”, “estimate” or “plan”, and other similar terms. Although Sanofi’s management believes these forward-looking statements to be reasonable, investors are cautioned that these forward-looking statements are subject to numerous risks and uncertainties, which are difficult to predict and generally beyond Sanofi’s control, which may mean that actual results and events realized differ materially from those expressed, implied or anticipated in the forward-looking information and statements. These risks and uncertainties include, but are not limited to, uncertainties inherent in research and development, future clinical data and analyses, including post-marketing, decisions by regulatory authorities, such as the FDA or EMA, approval whether or not, and on what date, of the drug, process or biologic application for any of these product candidates, as well as their decisions regarding labeling and other factors that may affect the availability or commercial potential of such product candidates, the fact that the product candidates if approved may not achieve commercial success, the future approval and commercial success of alternative therapeutics, the ability to Sanofi to seize external growth opportunities and finalize related transactions, changes in exchange rates and interest rates, the instability of economic and market conditions é, , cost containment initiatives and their evolution, the impact that COVID-19 will have on Sanofi, its customers, suppliers and partners and their financial situation, as well as on its employees and on the global economy. Any significant impact on these could negatively impact Sanofi. The situation is changing rapidly and other consequences of which we are unaware could appear and exacerbate the risks previously identified. These risks and uncertainties also include those discussed or identified in Sanofi’s public filings with the AMF and the SEC, including those listed under the “Risk Factors” and “Forward-Looking Statements” sections of the Registration Document. universal registration 2021 of Sanofi, which has been filed with the AMF as well as in the sections “Risk Factors” and “Cautionary Statement Concerning Forward-Looking Statements” of the 2021 annual report on Form 20-F of Sanofi, which has been filed with the SEC. Sanofi makes no commitment to update forward-looking information and statements subject to applicable regulations, in particular articles 223-1 et seq. of the general regulations of the Autorité des marchés financiers.
Attachment