TARRYTOWN, N.Y. and
PARIS, Feb.
12, 2021 /PRNewswire/ --
Libtayo was superior in extending overall survival compared
to chemotherapy even with a high crossover rate
Data are the basis for multiple ongoing regulatory
submissions, including in the U.S. and European Union
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today
announced The Lancet published results from a pivotal
trial designed to evaluate the investigational use of the PD-1
inhibitor Libtayo® (cemiplimab) compared to
platinum-doublet chemotherapy in patients with locally advanced or
metastatic non-small cell lung cancer (NSCLC) with ≥50% PD-L1
expression in tumor cells. The data were shared during a
late-breaking presentation at the 2020 European Society for Medical
Oncology (ESMO) Virtual Congress and formed the basis of regulatory
submissions in the U.S. and European Union (EU). The U.S. Food and
Drug Administration (FDA) granted a Priority Review with a target
action date of February 28, 2021. A
European Commission decision is expected by mid-2021.
"These clinical results published in The Lancet support
regulatory submissions for Libtayo as a potential new treatment
option for patients with advanced NSCLC with PD-L1 expression of
≥50%," said Ahmet Sezer, M.D.,
Professor in the Department of Medical Oncology at Başkent
University in Adana, Turkey and a
trial investigator. "Libtayo was superior in extending overall
survival compared to chemotherapy, even with 74% of patients
crossing over to the Libtayo arm following progression on
chemotherapy. Libtayo reduced the risk of death by 32% in all
patients in the pivotal trial and by 43% among those with confirmed
PD-L1 expression of 50% or higher. In addition, the data included
more advanced patient populations usually underrepresented in
advanced NSCLC trials – including 12% with pretreated and stable
brain metastases and 16% with locally advanced NSCLC who were not
candidates for definitive chemoradiation. As a result, the medical
community now has valuable new clinical evidence that could enhance
our understanding of how to treat this deadly cancer."
The safety of Libtayo in the trial was generally consistent with
previous Libtayo pivotal trials, and according to the publication,
consistent with the safety profiles of other PD-1 or PD-L1
inhibitors in NSCLC and other tumor types. Grade 3 or 4 adverse
events occurred in 28% and 39% of patients in the Libtayo and
chemotherapy arms, respectively. Immune-mediated AEs were reported
in 17% of patients in the Libtayo arm, compared to 2% in the
chemotherapy arm, and included hypothyroidism (6% versus 0%),
hyperthyroidism (4% versus <1%), pneumonitis (2% versus 0%),
hepatitis (2% versus 0%), skin adverse reaction (2% versus <1%),
colitis (1% versus <1%), nephritis (<1% versus <1%),
arthritis, increased blood thyroid stimulating hormone,
thyroiditis, and peripheral neuropathy (all <1% versus 0%).
Libtayo is currently approved as the first systemic treatment in
the U.S., EU and other countries for adults with metastatic
cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC
who are not candidates for curative surgery or curative radiation.
Libtayo is also approved in the U.S. as the first
immunotherapy treatment indicated for patients with advanced basal
cell carcinoma (BCC) previously treated with a hedgehog pathway
inhibitor (HHI) or for whom an HHI is not appropriate, and is under
regulatory review in the EU for the treatment of locally advanced
BCC previously treated with an HHI.
Libtayo was invented using Regeneron's
VelocImmune® technology that utilizes a
proprietary genetically-engineered mouse platform endowed with a
genetically-humanized immune system to produce optimized
fully-human antibodies. VelocImmune technology has also been
used to create multiple antibodies including Dupixent®
(dupilumab), Praluent® (alirocumab), Kevzara®
(sarilumab), Evkeeza™ (evinacumab-dgnb), Inmazeb™ (atoltivimab,
maftivimab, and odesivimab-ebgn) and Regeneron's antibody cocktail
for COVID-19, which was recently granted Emergency Use
Authorization (EUA) in the U.S.
Libtayo is being jointly developed and commercialized by
Regeneron and Sanofi under a global collaboration agreement.
The use of Libtayo to treat advanced NSCLC is investigational
and has not been fully evaluated by any regulatory authority.
About the Phase 3 Trial
The open-label, randomized,
multi-center Phase 3 trial, called EMPOWER-Lung 1, was designed to
investigate the first-line treatment of Libtayo monotherapy
compared to platinum-doublet chemotherapy in patients with squamous
or non-squamous advanced NSCLC that tested positive for PD-L1 in
≥50% of tumor cells, but not for ALK, EGFR or ROS1. PD-L1
expression was confirmed using the PD-L1 IHC 22C3 pharmDx kit. The
trial randomized 710 patients with either locally advanced NSCLC
(stage IIIB/C) who were not candidates for surgical resection or
definitive chemoradiation or had progressed after treatment with
definitive chemoradiation, or previously untreated metastatic NSCLC
(stage IV). Of the 710 patients randomized to receive treatment,
563 patients had confirmed PD-L1 expression of ≥50%.
Patients were randomized 1:1 to receive either Libtayo 350 mg
administered intravenously every three weeks for up to 108 weeks or
an investigator-selected, standard-of-care, platinum-based, doublet
chemotherapy regimen for 4 to 6 cycles (with or without histology
relevant maintenance pemetrexed chemotherapy). The co-primary
endpoints were overall survival and progression-free survival, and
secondary endpoints included overall response rate, duration of
response and quality of life.
The trial was designed to reflect current and emerging treatment
paradigms. Inclusion criteria allowed patients with NSCLC who had:
pre-treated and stable brain metastases; locally advanced disease
that was not a candidate for, or which had progressed after,
definitive chemoradiation; or controlled hepatitis B, hepatitis C
or HIV. Patients whose disease progressed in the trial were able to
change their therapy: those in the chemotherapy arm were allowed to
cross over into the Libtayo arm following disease progression on
chemotherapy; and those in the Libtayo arm were allowed to combine
Libtayo treatment with 4 to 6 cycles of chemotherapy.
About Non-small Cell Lung Cancer
Lung cancer is the leading cause of cancer death worldwide. In
2020, an estimated 2.2 million and 225,000 new cases were diagnosed
worldwide and in the U.S, respectively. Approximately 84% of all
lung cancers are NSCLC, and an estimated 25% to 30% of these cases
are expected to test positive for PD-L1 in ≥50% of tumor cells.
Additionally, an estimated 75% of patients are diagnosed with
advanced NSCLC and have a poor survival prognosis. While
immunotherapies have transformed advanced NSCLC treatment in recent
years, there remains an unmet need to optimize the identification
and treatment of patients with high PD-L1 expression and offer
additional treatment options.
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., the generic name for Libtayo in its approved
indication is cemiplimab-rwlc, with rwlc as the suffix designated
in accordance with Nonproprietary Naming of Biological Products
Guidance for Industry issued by the FDA. Outside of the U.S., the
generic name for Libtayo in its approved indication is
cemiplimab.
The extensive clinical program for Libtayo is focused on
difficult-to-treat cancers. In skin cancer, this includes trials in
adjuvant and neoadjuvant CSCC. Libtayo is also being investigated
in pivotal trials in NSCLC (in combination with chemotherapy) and
cervical cancer, 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.
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 a hedgehog pathway inhibitor (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.
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 types
of skin cancer 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: 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 tiredness, rash,
diarrhea, muscle or bone pain, nausea, and itching. 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 Pharmaceuticals,
Inc.
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, 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
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statements that involve risks and uncertainties relating to future
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Inc. ("Regeneron" or the "Company"), and actual events or results
may differ materially from these forward-looking statements. Words
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including without limitation Libtayo® (cemiplimab); the
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treatment of locally advanced or metastatic non-small cell lung
cancer, locally advanced basal cell carcinoma previously treated
with a hedgehog pathway inhibitor (in the European Union and other
potential jurisdictions), adjuvant and neoadjuvant cutaneous
squamous cell carcinoma, and cervical cancer (as well as in
combination with either conventional or novel therapeutic
approaches for both solid tumors and blood cancers); uncertainty of
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and Regeneron's Product Candidates and the impact of studies
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extent to which the results from the research and development
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replicated in other studies and/or lead to advancement of product
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manage supply chains for multiple products and product candidates;
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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
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and Exchange Commission, including its Form 10-K for the year ended
December 31, 2020. Any
forward-looking statements are made based on management's current
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Regeneron
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