TARRYTOWN, N.Y. and
PARIS, June
25, 2021 /PRNewswire/ --
Approval based on a Phase 3 trial demonstrating Libtayo
significantly improved overall survival compared to chemotherapy in
advanced NSCLC that included challenging-to-treat patient
populations
Libtayo now approved by the European Commission for three
advanced cancers
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today
announced that the European Commission (EC) has approved the
PD-1 inhibitor Libtayo® (cemiplimab) for the first-line
treatment of adults with non-small cell lung cancer (NSCLC) whose
tumor cells have ≥50% PD-L1 expression and no EGFR, ALK or ROS1
aberrations. Patients must have metastatic NSCLC or locally
advanced NSCLC and not be a candidate for definitive
chemoradiation.
Libtayo is now approved for three advanced cancers in the
European Union. The EC also approved Libtayo in advanced basal cell
carcinoma (BCC), the first treatment to be indicated for those
patients who have progressed on or are intolerant to a hedgehog
pathway inhibitor (HHI). In 2019, Libtayo was approved by the
EC as the first treatment for adults with metastatic or locally
advanced cutaneous squamous cell carcinoma (CSCC) who are not
candidates for curative surgery or curative radiation. Across all
of its approved indications, Libtayo had a generally consistent
safety profile. Immune-mediated adverse reactions, which may be
severe or fatal, can occur in any organ system or tissue during or
after treatment with Libtayo.
"Libtayo has demonstrated a highly significant improvement in
overall survival compared to chemotherapy for patients with
advanced non-small cell lung cancer with high PD-L1 expression and
a variety of challenging-to-treat disease characteristics," said
Israel Lowy, M.D., Ph.D., Senior
Vice President, Translational and Clinical Sciences, Oncology at
Regeneron. "Beyond the primary analysis, we continue to
conduct post-hoc analyses of our Phase 3 trial with the goal of
informing treatment in this patient population."
The EC approval in advanced NSCLC is based on data from a global
Phase 3 trial that enrolled 710 patients from 24 countries. The
trial, which was one of the largest for a PD-1 inhibitor in
advanced NSCLC, was designed to be more reflective of clinical
practice by including challenging-to-treat and often
underrepresented disease characteristics. Among
those enrolled, 12% had pre-treated and clinically stable
brain metastases, 44% had squamous cell histology and 16% had
locally advanced NSCLC that was not a candidate for definitive
chemoradiation. Furthermore, patients whose disease progressed in
the trial were able to change their therapy: those assigned to
chemotherapy could crossover to Libtayo treatment, while those
assigned to Libtayo monotherapy could continue Libtayo treatment
and add four cycles of chemotherapy.
In the overall study population, Libtayo significantly reduced
the risk of death by 32% and extended median overall survival (OS)
by 8 months compared to chemotherapy, even with 74% of patients
crossing over to Libtayo following disease progression on
chemotherapy (hazard ratio [HR]: 0.68; 95% confidence interval
[CI]: 0.53-0.87; p=0.0022). The median OS was 22 months for Libtayo
(range: 18 months to not evaluable) and 14 months for chemotherapy
(range: 12 to 19 months). A prespecified analysis of data from
patients whose cancers had PD-L1 expression ≥50% (n=563) based on a
validated assay was also conducted. As published in The
Lancet, Libtayo reduced the risk of death by 43% for patients
in this population; median OS was not reached for Libtayo (95% CI:
18 months to not evaluable) and was 14 months for chemotherapy (95%
CI: 11 to 18 months).
In the Phase 3 trial, safety was assessed in 697 patients,
with a duration of exposure of 27 weeks (range: 9 days to 115
weeks) for the Libtayo group and 18 weeks (range: 18 days to 87
weeks) for the chemotherapy group. Serious adverse reactions (AEs)
in at least 2% of patients were pneumonia (5% Libtayo, 6%
chemotherapy) and pneumonitis (2% Libtayo, 0% chemotherapy).
Treatment was permanently discontinued due to AEs in 6% of Libtayo
patients; AEs resulting in permanent discontinuation in at least 2
patients were pneumonitis, pneumonia, ischemic stroke and increased
aspartate aminotransferase. No new Libtayo safety signals were
observed.
"We are confident that Libtayo has the potential to become an
important treatment option for patients in the European Union and
thank all the investigators, patients and their families who helped
us reach this milestone," said Peter C.
Adamson, M.D., Global Development Head, Oncology at Sanofi.
"We are anticipating results from our ongoing Phase 3 trial of
Libtayo plus chemotherapy in patients with advanced non-small cell
lung cancer and remain committed to studying Libtayo in additional
cancer settings where there is the potential to improve the outcome
for patients."
About the Phase 3 Trial in Advanced NSCLC
EMPOWER-Lung
1 was an open-label, randomized, multi-center Phase 3 trial
designed to investigate Libtayo monotherapy compared to
platinum-doublet chemotherapy as first-line treatment in patients
with advanced NSCLC who tested positive for PD-L1 in ≥50% of tumor
cells and had no EGFR, ALK or ROS1 aberrations. PD-L1 expression
was confirmed using the Agilent Dako PD-L1 IHC 22C3 pharmDx
kit.
The trial randomized 710 patients 1:1 who had either previously
untreated metastatic NSCLC (stage IV) or locally advanced
NSCLC (stage IIIB/C) who were not candidates for surgical resection
or definitive chemoradiation or who had progressed after treatment
with definitive chemoradiation. Those receiving Libtayo were
intravenously administered a 350 mg dose every three weeks for up
to 108 weeks, while those receiving chemotherapy received an
investigator-selected, platinum-doublet chemotherapy regimen for
four to six cycles (with or without maintenance pemetrexed
chemotherapy).
The primary endpoints were OS and progression-free survival, and
secondary endpoints included objective response rate, duration of
response and quality of life. In 2020, the trial was
stopped early due to a significant improvement in OS.
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.
The extensive clinical program for Libtayo is focused on
difficult-to-treat cancers. Current clinical development programs
include Libtayo in combination with chemotherapy for advanced NSCLC
irrespective of PD-L1 expression and Libtayo monotherapy for
advanced cervical cancer. Libtayo is also being investigated in
combination with either conventional or novel therapeutic
approaches for other solid tumors and blood cancers. These
potential uses are investigational, and their safety and efficacy
have not been evaluated by any regulatory authority.
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). 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 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 and 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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programs, Regeneron's ability to manage its supply chain, net
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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 non-small cell lung cancer ("NSCLC"); uncertainty
of the utilization, market acceptance, and commercial success of
Regeneron's Products (such as Libtayo) 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 foregoing;
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 possible regulatory
approval of Libtayo in combination with chemotherapy for advanced
NSCLC irrespective of PD-L1 expression and as monotherapy for
advanced cervical cancer (as well as in combination with either
conventional or novel therapeutic approaches for both solid tumors
and blood cancers); the ability of Regeneron's collaborators,
suppliers, or other third parties (as applicable) to perform
manufacturing, filling, finishing, packaging, labeling,
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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 serious complications or side
effects in connection with the use of Regeneron's Products and
Regeneron's Product Candidates in clinical trials; determinations
by regulatory and administrative governmental authorities which may
delay or restrict Regeneron's ability to continue to develop or
commercialize Regeneron's Products and Regeneron's Product
Candidates, including without limitation Libtayo; ongoing
regulatory obligations and oversight impacting Regeneron's
Products, research and clinical programs, and business, including
those relating to patient privacy; the availability and extent of
reimbursement of Regeneron's Products 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 collaborators may be replicated
in other studies and/or lead to advancement of product candidates
to clinical trials, therapeutic applications, or regulatory
approval; unanticipated expenses; the costs of developing,
producing, and selling products; the ability of Regeneron to meet
any of its financial projections or guidance and changes to the
assumptions underlying those projections or guidance; the potential
for any license, collaboration, or supply agreement, including
Regeneron's agreements with Sanofi, Bayer, and 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-COV™ (casirivimab and imdevimab)), other litigation and
other proceedings and government investigations relating to the
Company and/or its operations, the ultimate outcome 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
social media outlets to publish important information about the
Company, including information that may be deemed material to
investors. Financial and other information about Regeneron is
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Sanofi Forward-Looking Statements
This 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 regarding
the marketing and other potential of the product, or regarding
potential future revenues from the product. Forward-looking
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Regeneron
Contacts:
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Relations
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Tel: +1
914-847-1328
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Relations
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Tosic
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vesna.tosic@regeneron.com
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Sanofi
Contacts:
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Relations
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205-2572
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Investor Relations
Paris
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Arnaud
Delepine
Nathalie
Pham
Investor Relations
North America
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Fara
Berkowitz
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IR main
line:
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45 45
investor.relations@sanofi.com https://www.sanofi.com/en/investors/contact
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