TARRYTOWN, N.Y. and
PARIS, Aug.
5, 2021 /PRNewswire/ --
Libtayo combined with chemotherapy increased median overall
survival from 13 to 22 months, leading to a 29% reduction in the
risk of death
Trial enrolled patients with locally advanced and metastatic
disease with squamous or non-squamous histology, across all PD-L1
expression levels
Libtayo has now demonstrated improved overall survival as a
monotherapy or in combination with chemotherapy in first-line
advanced non-small cell lung cancer
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi
today announced the Phase 3 trial of PD-1 inhibitor Libtayo in
combination with platinum-doublet chemotherapy was stopped early
after meeting its overall survival (OS) primary endpoint in
patients with advanced non-small cell lung cancer (NSCLC). Adding
Libtayo to chemotherapy significantly improved OS, compared to
chemotherapy alone, in the trial that enrolled patients with
metastatic or locally advanced disease and tumors with either
squamous or non-squamous histology and across all PD-L1 expression
levels. These data are planned to form the basis of regulatory
submissions in the U.S. and European Union.
"Libtayo in combination with chemotherapy increased median
overall survival to 22 months in patients with advanced non-small
cell lung cancer, compared to 13 months with chemotherapy alone,"
said Miranda Gogishvili, M.D., an
oncologist at the High Technology Medical Center, University
Clinic, in Tbilisi, Georgia and a
trial investigator. "Notably, the Phase 3 trial enrolled patients
with a variety of challenging-to-treat disease characteristics, as
well as those with locally advanced disease. These data add to the
growing body of evidence supporting Libtayo in advanced non-small
cell lung cancer, which also include the pivotal results for
Libtayo monotherapy in cases of high PD-L1 expression."
The decision to stop the trial early was based on a
recommendation by the Independent Data Monitoring Committee (IDMC)
during a protocol-specified interim analysis. In this top-line
initial analysis of 466 patients, combining Libtayo with
chemotherapy reduced the risk of death by 29% compared to
chemotherapy alone (hazard ratio: 0.71; 95% confidence interval
[CI]: 0.53-0.93; p=0.014). Median OS was 22 months (95% CI: 16
months to not evaluable) for Libtayo and chemotherapy, and 13
months (95% CI: 12 to 16 months) for chemotherapy alone. No new
Libtayo safety signals were identified in the IDMC analysis, and
additional detailed efficacy and safety data will be presented at
an upcoming medical meeting.
Lung cancer is the leading cause of cancer death worldwide. In
2020, an estimated 2.2 million and 225,000 new cases were diagnosed
globally and in the U.S., respectively. Approximately 84% of all
lung cancers are NSCLC, with 75% of these cases diagnosed in
advanced stages. While PD-1 inhibitor monotherapy has primarily
advanced the treatment of NSCLC with ≥50% PD-L1 expression,
approximately 70% of all NSCLC cases will have <50% PD-L1
expression, making it the most common treatment setting.
The use of Libtayo in combination with chemotherapy for advanced
NSCLC is currently under clinical investigation, and its safety and
efficacy have not been fully evaluated by any regulatory
authority.
About the Phase 3 Trial
The randomized, multicenter
Phase 3 trial, called EMPOWER-Lung 3, investigated a first-line
combination treatment of Libtayo and platinum-doublet chemotherapy,
compared to platinum-doublet chemotherapy alone, in squamous or
non-squamous advanced NSCLC irrespective of PD-L1 expression.
Specifically, the trial included 466 patients who tested negative
for ALK, EGFR and ROS1 mutations and had either previously
untreated metastatic NSCLC (stage IV) or locally advanced NSCLC
(stage IIIB/C) and were not candidates for definitive
chemoradiation.
Patients were randomized 2:1 to receive either Libtayo 350 mg
(n=312) or placebo (n=154) administered intravenously every three
weeks for 108 weeks, plus platinum-doublet chemotherapy
administered every three weeks for four cycles. The co-primary
endpoints were OS and progression-free survival, and key secondary
endpoints included objective response rate and best overall
response.
Among trial patients, 30% (n=139) had tumors with <1% PD-L1
expression, 38% (n=175) had tumors with 1% to 49% PD-L1 expression,
and 33% (n=152) had tumors with ≥50% PD-L1 expression.
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 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. FDA. Libtayo is being jointly developed
by Regeneron and Sanofi under a global collaboration agreement.
The extensive clinical program for Libtayo is focused on
difficult-to-treat cancers. Libtayo is currently being investigated
in advanced cervical cancer, as well as in trials combining Libtayo
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.
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 a 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 a 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 accompanying 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.
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
collaborators' ability to continue to conduct research and clinical
programs, Regeneron's ability to manage its supply chain, net
product sales of products marketed or otherwise commercialized by
Regeneron and/or its collaborators (collectively, "Regeneron's
Products"), and the global economy; the nature, timing, and
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) in
combination with chemotherapy for the treatment of patients with
advanced non-small cell lung cancer ("NSCLC"); 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 NSCLC 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); 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 ability of Regeneron's
collaborators, suppliers, or other third parties (as applicable) to
perform manufacturing, filling, finishing, packaging, labeling,
distribution, and other steps 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 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-COVTM (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. 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
routinely posted and is accessible on Regeneron's media and
investor relations website (http://newsroom.regeneron.com) and its
Twitter feed (http://twitter.com/regeneron).
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 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 performance.
Forward-looking statements are generally identified by the words
"expects", "anticipates", "believes", "intends", "estimates",
"plans" and similar expressions. Although Sanofi's management
believes that the expectations reflected in such 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
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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
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whole. Any material effect of COVID-19 on any of the
foregoing could also adversely impact us. This situation is
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Sanofi's annual report on Form 20-F for the year ended December 31, 2020. Other than as required by
applicable law, Sanofi does not undertake any obligation to update
or revise any forward-looking information or statements.
Regeneron
Contacts:
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Sanofi
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