TARRYTOWN, N.Y. and
PARIS, May
12, 2021 /PRNewswire/ --
Libtayo is the first immunotherapy to demonstrate an
improvement in overall survival in advanced cervical cancer, as
well as progression-free survival and objective response rate,
compared to chemotherapy
Improvements in overall survival were seen in the overall
population and both squamous cell carcinoma and adenocarcinoma
subgroups
Additionally, the Phase 3 trial found significant differences
in patient-reported outcomes favoring Libtayo over
chemotherapy
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today
announced the presentation of positive results from the Phase 3
trial investigating the PD-1 inhibitor Libtayo®
(cemiplimab) in patients with recurrent or metastatic cervical
cancer who had previously progressed on chemotherapy. The data were
shared as part of a European Society for Medical Oncology (ESMO)
Virtual Plenary and add to previously reported data showing an
improvement in overall survival (OS) with Libtayo compared to
chemotherapy. The data will form the basis of regulatory
submissions in 2021.
"In this Phase 3 trial, Libtayo demonstrated a significant
improvement in overall survival in women with advanced cervical
cancer after progression on chemotherapy, reducing the risk of
death by 31% compared to chemotherapy in the overall population,"
said Krishnansu S. Tewari, M.D., Professor and Director of the
Division of Gynecologic Oncology at the University of California, Irvine and a trial
investigator. "Improvements in progression-free survival and
objective response rate were also demonstrated in the overall
population compared to chemotherapy. Taken together, this
landmark trial – which enrolled patients regardless of PD-L1
expression status – helps support the use of Libtayo as a potential
new second-line treatment for women with advanced cervical cancer
who face a poor prognosis and limited treatment options."
In the overall population, those treated with Libtayo (n=304)
experienced significant improvements in OS, progression-free
survival (PFS) and objective response rate (ORR), compared to
chemotherapy (n=304), including a:
- 31% reduction in the risk of death (hazard ratio [HR]:
0.69; 95% confidence interval [CI]: 0.56-0.84; one-sided
p=0.00011).
- 25% reduction in the risk of disease progression (HR:
0.75; 95% CI: 0.63-0.89; one-sided p=0.00048).
- 16% ORR (50 patients; 95% CI: 13-21%; one-sided
p=0.00004), compared to 6% with chemotherapy (19 patients). Median
duration of response was 16 months with Libtayo (95% CI: 12 months
to not yet evaluable) and 7 months with chemotherapy (95% CI: 5-8
months), per Kaplan-Meier estimates.
In the trial, 78% of patients had advanced cervical cancer that
was classified as squamous cell carcinoma (SCC). In this patient
subgroup, significant improvements were also seen with Libtayo
(n=239), compared to chemotherapy (n=238), including a:
- 27% reduction in the risk of death (HR: 0.73; 95% CI:
0.58-0.91; one-sided p=0.00306).
- 29% reduction in the risk of disease progression (HR:
0.71; 95% CI: 0.58-0.86; one-sided p=0.00026).
- 18% ORR (42 patients; 95% CI: 13-23%), compared to 7%
with chemotherapy (16 patients; 95% CI: 4-11%).
While assessment of the adenocarcinoma was not a pre-specified
endpoint, a post-hoc analysis demonstrated the following outcomes
for Libtayo-treated patients (n=65) compared to chemotherapy
(n=66), including a:
- 44% reduction in the risk of death (HR: 0.56; 95% CI:
0.36-0.85; nominal one-sided p<0.005).
- 9% reduction in the risk of disease progression (HR:
0.91; 95% CI: 0.62-1.34).
- 12% ORR (8 patients; 95% CI: 6-23%), compared to 5% with
chemotherapy (3 patients; 95% CI: 1-13%).
Additionally, the Phase 3 trial found Libtayo-treated patients
were able to generally improve or maintain their baseline Global
Health Status/Quality of Life (GHS/QOL) over time, while those
treated with chemotherapy experienced a deterioration that became
clinically meaningful starting at cycle 8, per the EORTC QLQ-C30
(overall estimated mean change [95% CI]: improvement of 1.01
[-2.033, 4.047] for Libtayo, worsening of -6.81 [-10.977, -2.637]
for chemotherapy; difference: 7.81; one-sided nominal
p=0.00040).
No new Libtayo safety signals were observed. Safety was assessed
in patients who received at least 1 dose of study treatment: 300
patients in the Libtayo group (median duration of exposure: 15
weeks; range: 1-101 weeks) and 290 patients in the chemotherapy
group (median duration of exposure: 10 weeks; range: 1-82 weeks).
Adverse events (AEs) were observed in 88% of Libtayo patients and
91% of chemotherapy patients, with those occurring in 15% or more
Libtayo patients being anemia (25% Libtayo, 45% chemotherapy),
nausea (18% Libtayo, 33% chemotherapy), fatigue (17% Libtayo, 16%
chemotherapy), vomiting (16% Libtayo, 23% chemotherapy), decreased
appetite (15% Libtayo, 16% chemotherapy) and constipation (15%
Libtayo, 20% chemotherapy). Grade 3 or higher AEs occurred in 45%
of Libtayo patients and 53% of chemotherapy patients. Among AEs in
15% or more patients, Grade 3 or higher AEs that occurred more
often in the Libtayo group included asthenia (2% Libtayo, 1%
chemotherapy) and pyrexia (less than 1% Libtayo, 0% chemotherapy).
Immune-related AEs were observed in 16% of Libtayo patients and
less than 1% of chemotherapy patients, with 6% and less than 1%
being Grade 3 or higher, respectively. Discontinuations due to AEs
occurred in 8% of Libtayo patients and 5% of chemotherapy
patients.
The use of Libtayo in advanced cervical cancer is
investigational and has not been fully reviewed by any regulatory
authority.
About the Phase 3 Trial
The Phase 3, open-label,
multi-center trial is the largest randomized clinical trial in
advanced cervical cancer, and investigated Libtayo monotherapy
versus an investigator's choice of chemotherapy in patients with
recurrent or metastatic cervical cancer that has progressed on
platinum-based chemotherapy. Patients were allowed to enroll
regardless of PD-L1 expression status, with 78% of patients having
SCC and 22% having adenocarcinoma or adenosquamous carcinoma. The
trial included women from 14 countries: the U.S., Japan, Taiwan, South
Korea, Canada, Russia, Poland, Spain, Brazil, Australia, the UK, Italy, Greece
and Belgium.
Patients (median age: 51 years) were randomized to receive
Libtayo monotherapy (350 mg every three weeks) or an investigator's
choice of commonly used chemotherapy (pemetrexed, vinorelbine,
topotecan, irinotecan or gemcitabine). The primary endpoint for the
trial was OS, analyzed first among patients with SCC, then in the
total population.
In March, the trial was stopped early based on the highly
significant effect of Libtayo on OS among SCC patients and
following a unanimous recommendation by the Independent Data
Monitoring Committee.
About Cervical Cancer
Cervical cancer is the fourth
leading cause of cancer death in women worldwide and is most
frequently diagnosed in women between the ages of 35 and
44. Almost all cases are caused by human papillomavirus (HPV)
infection, with approximately 80% classified as SCC (arising from
cells lining the bottom of the cervix) and the remainder being
largely adenocarcinomas (arising from glandular cells in the upper
cervix). Cervical cancer is often curable when detected early and
effectively managed, but treatment options are more limited in
advanced stages.
It is estimated that approximately 570,000 women are diagnosed
with cervical cancer worldwide each year, with deaths exceeding
250,000. In the U.S. there are 14,500 new patients diagnosed
annually and approximately 4,000 women die each year.
About Libtayo
Libtayo is a fully human monoclonal
antibody targeting the immune checkpoint receptor PD-1 on T-cells.
By binding to PD-1, Libtayo has been shown to block cancer cells
from using the PD-1 pathway to suppress T-cell activation.
In the U.S., Libtayo is approved for certain patients with
advanced stages of cutaneous squamous cell carcinoma (CSCC), basal
cell carcinoma (BCC) and non-small cell lung cancer (NSCLC) with
≥50% PD-L1 expression. Outside of the U.S., Libtayo is approved for
certain patients with advanced CSCC in the European Union and six
other countries, including Australia, Brazil, the UK and Canada.
The generic name for Libtayo in its approved U.S. indications is
cemiplimab-rwlc, with rwlc as the suffix designated in accordance
with Nonproprietary Naming of Biological Products Guidance for
Industry issued by the U.S. Food and Drug Administration (FDA).
Outside of the U.S., the generic name for Libtayo in its approved
indication is cemiplimab.
About the Libtayo Development Program
The extensive
clinical program for Libtayo is focused on difficult-to-treat
cancers. The European Medicines Agency is assessing regulatory
submissions for Libtayo monotherapy in advanced NSCLC with ≥50%
PD-L1 expression and advanced BCC following treatment with a
hedgehog pathway inhibitor, with European Commission decisions
expected by mid-2021.
Libtayo monotherapy is being investigated in trials in adjuvant
CSCC and neoadjuvant CSCC, as well as in trials combining Libtayo
with either conventional or novel therapeutic approaches for both
solid tumors and blood cancers. These potential uses are
investigational, and their safety and efficacy have not been
evaluated by any regulatory authority.
Libtayo is being jointly developed by Regeneron and Sanofi under
a global collaboration agreement.
About
Regeneron's VelocImmune® Technology
Regeneron's
VelocImmune technology utilizes a proprietary genetically
engineered mouse platform endowed with a genetically humanized
immune system to produce optimized fully human antibodies. When
Regeneron's co-Founder, President and Chief Scientific Officer
George D. Yancopoulos was a graduate
student with his mentor Frederick W.
Alt in 1985, they were the first to envision making
such a genetically humanized mouse, and Regeneron has spent decades
inventing and developing VelocImmune and related
VelociSuite® technologies. Dr. Yancopoulos and
his team have used VelocImmune technology to create
approximately a quarter of all original, FDA-approved fully human
monoclonal antibodies currently available. This includes REGEN–COV™
(casirivimab with imdevimab), Dupixent® (dupilumab),
Libtayo® (cemiplimab-rwlc), Praluent®
(alirocumab), Kevzara® (sarilumab), Evkeeza®
(evinacumab-dgnb) and Inmazeb™ (atoltivimab, maftivimab and
odesivimab-ebgn).
IMPORTANT SAFETY INFORMATION AND INDICATION FOR U.S.
PATIENTS
What is Libtayo?
Libtayo is a prescription medicine
used to treat people with a type of skin cancer called cutaneous
squamous cell carcinoma (CSCC) that has spread or cannot be cured
by surgery or radiation.
Libtayo is a prescription medicine used to treat people with a
type of skin cancer called basal cell carcinoma that cannot be
removed by surgery (locally advanced BCC) and have received
treatment with an HHI, or cannot receive treatment with an HHI.
Libtayo is a prescription medicine used to treat people with a
type of skin cancer called basal cell carcinoma that has spread
(metastatic BCC) and have received treatment with a hedgehog
pathway inhibitor (HHI), or cannot receive treatment with an HHI.
This use is approved based on how many patients responded to
treatment and how long they responded. Studies are ongoing to
provide additional information about clinical benefit.
Libtayo is a prescription medicine used to treat people with a
type of lung cancer called non-small cell lung cancer (NSCLC).
Libtayo may be used as your first treatment when your lung cancer
has not spread outside your chest (locally advanced lung cancer)
and you cannot have surgery or chemotherapy with radiation, or your
lung cancer has spread to other areas of your body (metastatic lung
cancer), and your tumor tests positive for high "PD-L1" and your
tumor does not have an abnormal "EGFR", "ALK "or "ROS1" gene.
It is not known if Libtayo is safe and effective in
children.
What is the most important information I should know about
Libtayo?
Libtayo is a medicine that may treat certain
cancers by working with your immune system. Libtayo can cause your
immune system to attack normal organs and tissues in any area of
your body and can affect the way they work. These problems can
sometimes become severe or life-threatening and can lead to death.
You can have more than one of these problems at the same time.
These problems may happen anytime during treatment or even after
your treatment has ended.
Call or see your healthcare provider right away if you
develop any new or worsening signs or symptoms, including:
- Lung problems: cough, shortness of breath, or chest
pain
- Intestinal problems: diarrhea (loose stools) or more
frequent bowel movements than usual, stools that are black, tarry,
sticky or have blood or mucus, or severe stomach-area (abdomen)
pain or tenderness
- Liver problems: yellowing of your skin or the whites of
your eyes, severe nausea or vomiting, pain on the right side of
your stomach area (abdomen), dark urine (tea colored), or bleeding
or bruising more easily than normal
- Hormone gland problems: headache that will not go away
or unusual headaches, eye sensitivity to light, eye problems, rapid
heartbeat, increased sweating, extreme tiredness, weight gain or
weight loss, feeling more hungry or thirsty than usual, urinating
more often than usual, hair loss, feeling cold, constipation, your
voice gets deeper, dizziness or fainting, or changes in mood or
behavior, such as decreased sex drive, irritability, or
forgetfulness
- Kidney problems: decrease in your amount of urine, blood
in your urine, swelling of your ankles, or loss of appetite
- Skin problems: rash, itching, skin blistering or
peeling, painful sores or ulcers in mouth or nose, throat, or
genital area, fever or flu-like symptoms, or swollen lymph
nodes
- Problems can also happen in other organs and tissues. These
are not all of the signs and symptoms of immune system problems
that can happen with Libtayo. Call or see your healthcare provider
right away for any new or worsening signs or symptoms, which may
include: chest pain, irregular heartbeat, shortness of breath
or swelling of ankles, confusion, sleepiness, memory problems,
changes in mood or behavior, stiff neck, balance problems, tingling
or numbness of the arms or legs, double vision, blurry vision,
sensitivity to light, eye pain, changes in eyesight, persistent or
severe muscle pain or weakness, muscle cramps, low red blood cells,
or bruising
- Infusion reactions that can sometimes be severe. Signs
and symptoms of infusion reactions may include: nausea, chills or
shaking, itching or rash, flushing, shortness of breath or
wheezing, dizziness, feel like passing out, fever, back or neck
pain, or facial swelling
- Rejection of a transplanted organ. Your healthcare
provider should tell you what signs and symptoms you should report
and monitor you, depending on the type of organ transplant that you
have had.
- Complications, including graft-versus-host disease (GVHD),
in people who have received a bone marrow (stem cell) transplant
that uses donor stem cells (allogeneic). These complications
can be serious and can lead to death. These complications may
happen if you underwent transplantation either before or after
being treated with Libtayo. Your healthcare provider will monitor
you for these complications.
Getting medical treatment right away may help keep these
problems from becoming more serious. Your healthcare provider
will check you for these problems during your treatment with
Libtayo. Your healthcare provider may treat you with corticosteroid
or hormone replacement medicines. Your healthcare provider may also
need to delay or completely stop treatment with Libtayo if you have
severe side effects.
Before you receive Libtayo, tell your healthcare provider
about all your medical conditions, including if you:
-- have immune system problems such as Crohn's disease,
ulcerative colitis, or lupus
-- have received an organ transplant
-- have received or plan to receive a stem cell transplant that
uses donor stem cells (allogeneic)
-- have a condition that affects your nervous system, such as
myasthenia gravis or Guillain-Barré syndrome
-- are pregnant or plan to become pregnant. Libtayo can harm
your unborn baby
Females who are able to become pregnant:
- Your healthcare provider will give you a pregnancy test before
you start treatment.
- You should use an effective method of birth control during your
treatment and for at least 4 months after your last dose of
Libtayo. Talk with your healthcare provider about birth control
methods that you can use during this time.
- Tell your healthcare provider right away if you become pregnant
or think you may be pregnant during treatment with Libtayo.
-- are breastfeeding or plan to breastfeed. It is not known if
Libtayo passes into your breast milk.
Do not breastfeed during treatment and for at
least 4 months after the last dose of Libtayo.
Tell your healthcare provider about all the medicines you
take, including prescription and over- the-counter
medicines, vitamins, and herbal supplements.
The most common side effects of Libtayo include muscle or bone
pain, tiredness, rash, and diarrhea. These are not all the possible
side effects of Libtayo. Call your doctor for medical advice about
side effects. You may report side effects to FDA at 1-800-FDA-1088.
You may also report side effects to Regeneron Pharmaceuticals and
Sanofi at 1-877-542-8296.
Please see full Prescribing Information,
including Medication Guide.
About Regeneron
Regeneron (NASDAQ: REGN) is a leading
biotechnology company that invents life-transforming medicines for
people with serious diseases. Founded and led for over 30 years by
physician-scientists, our unique ability to repeatedly and
consistently translate science into medicine has led to nine
FDA-approved treatments and numerous product candidates in
development, almost all of which were homegrown in our
laboratories. Our medicines and pipeline are designed to help
patients with eye diseases, allergic and inflammatory diseases,
cancer, cardiovascular and metabolic diseases, pain, hematologic
conditions, infectious diseases and rare diseases.
Regeneron is accelerating and improving the traditional drug
development process through our proprietary VelociSuite
technologies, such as VelocImmune, which uses unique
genetically humanized mice to produce optimized fully human
antibodies and bispecific antibodies, and through ambitious
research initiatives such as the Regeneron Genetics Center, which
is conducting one of the largest genetics sequencing efforts in the
world.
For additional information about the company, please visit
www.regeneron.com or follow @Regeneron on Twitter.
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
Regeneron Forward-Looking Statements and Use of Digital
Media
This press release includes forward-looking
statements that involve risks and uncertainties relating to future
events and the future performance of Regeneron Pharmaceuticals,
Inc. ("Regeneron" or the "Company"), and actual events or results
may differ materially from these forward-looking statements. Words
such as "anticipate," "expect," "intend," "plan," "believe,"
"seek," "estimate," variations of such words, and similar
expressions are intended to identify such forward-looking
statements, although not all forward-looking statements contain
these identifying words. These statements concern, and these risks
and uncertainties include, among others, the impact of SARS-CoV-2
(the virus that has caused the COVID-19 pandemic) on Regeneron's
business and its employees, collaborators, and suppliers and other
third parties on which Regeneron relies, Regeneron's and its
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Regeneron and/or its collaborators (collectively, "Regeneron's
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possible success and therapeutic applications of Regeneron's
Products and product candidates being developed by Regeneron and/or
its collaborators (collectively, "Regeneron's Product Candidates")
and research and clinical programs now underway or planned,
including without limitation Libtayo® (cemiplimab) for
the treatment of patients with recurrent or metastatic cervical
cancer who had previously progressed on chemotherapy; the
likelihood, timing, and scope of possible regulatory approval and
commercial launch of Regeneron's Product Candidates and new
indications for Regeneron's Products, such as Libtayo for
the treatment of cervical cancer and adjuvant and
neoadjuvant cutaneous squamous cell carcinoma (as well as in
combination with either conventional or novel therapeutic
approaches for both solid tumors and blood cancers);
uncertainty of the utilization, market acceptance, and commercial
success of Regeneron's Products and Regeneron's Product
Candidates and the impact of studies (whether conducted by
Regeneron or others and whether mandated or voluntary), including
the study discussed in this press release, on any of the
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ability of Regeneron's collaborators, suppliers, or other third
parties (as applicable) to perform manufacturing, filling,
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related to Regeneron's Products and Regeneron's Product Candidates;
the ability of Regeneron to manufacture and manage supply chains
for multiple products and product candidates; safety issues
resulting from the administration of Regeneron's Products (such as
Libtayo) and Regeneron's Product Candidates in patients, including
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trials; determinations by regulatory and administrative
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ability to continue to develop or commercialize Regeneron's
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limitation Libtayo; ongoing regulatory obligations and oversight
impacting Regeneron's Products, research and clinical programs, and
business, including those relating to patient privacy; the
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from third-party payers, including private payer healthcare and
insurance programs, health maintenance organizations, pharmacy
benefit management companies, and government programs such as
Medicare and Medicaid; coverage and reimbursement determinations by
such payers and new policies and procedures adopted by such payers;
competing drugs and product candidates that may be superior to, or
more cost effective than, Regeneron's Products and Regeneron's
Product Candidates; the extent to which the results from the
research and development programs conducted by Regeneron and/or its
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Teva Pharmaceutical Industries Ltd. (or their respective affiliated
companies, as applicable), to be cancelled or terminated; and risks
associated with intellectual property of other parties and pending
or future litigation relating thereto (including without limitation
the patent litigation and other related proceedings relating to
EYLEA® (aflibercept) Injection, Dupixent®
(dupilumab), Praluent® (alirocumab), and
REGEN-COVTM (casirivimab with imdevimab)), other
litigation and other proceedings and government investigations
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of any such proceedings and investigations, and the impact any of
the foregoing may have on Regeneron's business, prospects,
operating results, and financial condition. A more complete
description of these and other material risks can be found in
Regeneron's filings with the U.S. Securities and Exchange
Commission, including its Form 10-K for the year ended December 31, 2020 and its Form 10-Q for the
quarterly period ended March 31,
2021. Any forward-looking statements are made based on
management's current beliefs and judgment, and the reader is
cautioned not to rely on any forward-looking statements made by
Regeneron. Regeneron does not undertake any obligation to update
(publicly or otherwise) any forward-looking statement, including
without limitation any financial projection or guidance, whether as
a result of new information, future events, or otherwise.
Regeneron uses its media and investor relations website and
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Sanofi Forward-Looking Statements
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release contains forward-looking statements as defined in the
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Forward-looking statements are statements that are not historical
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underlying assumptions, statements regarding plans, objectives,
intentions and expectations with respect to future financial
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Forward-looking statements are generally identified by the words
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Regeneron
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Eva
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SOURCE Regeneron Pharmaceuticals, Inc.