TARRYTOWN, N.Y. and
PARIS, May
24, 2021 /PRNewswire/ --
Libtayo recommended for approval in the first-line treatment
of certain patients with advanced non-small cell lung cancer whose
tumors have ≥50% PD-L1 expression
Libtayo also recommended for approval in patients with
advanced basal cell carcinoma who have progressed on or are
intolerant to a hedgehog pathway inhibitor
CHMP has now issued three positive opinions for Libtayo in
advanced cancers
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi
today announced that the European Medicines
Agency's (EMA) Committee for Medicinal Products for Human
Use (CHMP) has adopted positive opinions for
Libtayo® (cemiplimab) as monotherapy in two advanced
cancers.
The CHMP recommended the approval of Libtayo for the first-line
treatment of adults with non-small cell lung cancer (NSCLC)
expressing PD-L1 in ≥50% of tumor cells with no EGFR, ALK or ROS1
aberrations. Patients must have metastatic disease or locally
advanced disease that is not a candidate for definitive
chemoradiation. Libtayo was also recommended for approval in adults
with locally advanced or metastatic basal cell carcinoma (BCC) who
have progressed on or are intolerant to a hedgehog pathway
inhibitor (HHI). The European Commission is expected to make a
decision on both indications in the coming months.
The positive opinion for Libtayo in advanced NSCLC is based on
results from a Phase 3 trial, which allowed for the enrollment of
patients with disease characteristics frequently underrepresented
in advanced NSCLC pivotal trials, including those with pre-treated
and clinically stable brain metastases or locally advanced NSCLC
and who were not candidates for definitive chemoradiation. Results
from the pivotal trial were published in The Lancet in
February 2021.
The positive opinion for Libtayo in locally advanced and
metastatic BCC is based on results from the largest prospective
clinical trial in these patients previously treated with an HHI to
date, with data presented at the European Society for Medical
Oncology Virtual Congress 2020 and recently published in The
Lancet Oncology. Libtayo is the first immunotherapy to
receive a positive CHMP opinion for this indication.
Libtayo is currently approved in the European Union (EU)
and other countries for the treatment of certain patients with
advanced cutaneous squamous cell carcinoma (CSCC).
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 primary endpoints were overall survival and progression-free
survival, and secondary endpoints included objective response rate
(ORR), duration of response (DOR) and quality of life. In 2020, the
trial was stopped early due to significant improvement in
overall survival.
The trial randomized 710 patients with 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. Among those enrolled, 12% had
pre-treated and clinically stable brain metastases and 16% had
locally advanced NSCLC that was not a candidate for definitive
chemoradiation.
Patients whose disease progressed in the trial were able to
change their therapy: those assigned to chemotherapy were allowed
to crossover to Libtayo treatment, while those assigned to Libtayo
monotherapy were allowed to continue Libtayo treatment and add four
cycles of chemotherapy. There was a >70% crossover rate to
Libtayo following disease progression on chemotherapy.
About the Pivotal Trial in Advanced BCC
EMPOWER-BCC 1
was an open-label, multi-center, non-randomized Phase 2 trial of
patients with unresectable locally advanced or metastatic BCC
(nodal or distant). Patients in both cohorts had either progressed
on HHI therapy, had not had an objective response after nine months
on HHI therapy, or were intolerant of prior HHI therapy. The
primary efficacy endpoint was confirmed ORR and a key secondary
endpoint was DOR, assessed by independent central review.
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.
Libtayo is currently approved as the first systemic treatment in
the U.S., EU and other countries for adults with metastatic
CSCC or locally advanced CSCC who are not candidates for curative
surgery or curative radiation. In the U.S., Libtayo is
also approved as the first immunotherapy indicated for
patients with advanced BCC previously treated with an HHI or for
whom an HHI is not appropriate that is either locally advanced
(full approval) or metastatic (accelerated approval), as well as
for the first-line treatment of certain patients with advanced
NSCLC with ≥50% PD-L1 expression and no EGFR, ALK or ROS1
aberrations.
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).
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.
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,"
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and research and clinical programs now underway or planned,
including without limitation Libtayo® (cemiplimab) for
the treatment of non-small cell lung cancer ("NSCLC") and basal
cell carcinoma ("BCC"); the impact of the opinions adopted by the
European Medicines Agency's Committee for Medicinal Products for
Human Use discussed in this press release on any approval by the
European Commission of Libtayo for the treatment of NSCLC and/or
BCC in the European Union and the timing of any such approval;
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on any of the foregoing or any potential regulatory approval of
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possible regulatory approval of Libtayo for NSCLC and/or BCC in the
European Union discussed in this press release and possible
regulatory approval of Libtayo in other jurisdictions and
indications, including 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
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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
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and government programs such as Medicare and Medicaid; coverage and
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candidates that may be superior to, or more cost effective than,
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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
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SOURCE Regeneron Pharmaceuticals, Inc.