TARRYTOWN, N.Y. and
PARIS, Feb.
22, 2021 /PRNewswire/ --
Libtayo was superior in extending overall survival compared
to chemotherapy in a pivotal trial that allowed for certain disease
characteristics frequently underrepresented in advanced NSCLC
trials
This is the third approval for Libtayo in the U.S.
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today
announced that the U.S. Food and Drug Administration (FDA) has
approved the PD-1 inhibitor Libtayo® (cemiplimab-rwlc)
for the first-line treatment of patients with advanced non-small
cell lung cancer (NSCLC) whose tumors have high PD-L1 expression
(tumor proportion score ≥50%), as determined by an FDA-approved
test. Patients must either have metastatic or locally advanced
tumors that are not candidates for surgical resection or definitive
chemoradiation, and the tumors must not have EGFR, ALK or ROS1
aberrations.
"The approval of Libtayo to treat first-line advanced non-small
cell lung cancer with high PD-L1 expression means physicians and
patients have a potent new treatment option against this deadly
disease," said Naiyer Rizvi, M.D.,
Price Family Professor of Medicine, Director of Thoracic Oncology
and Co-director of Cancer Immunotherapy at Columbia University Irving Medical Center, as well
as a steering committee member of the trial. "Notably, Libtayo was
approved based on a pivotal trial where most chemotherapy patients
crossed over to Libtayo following disease progression, and that
allowed for frequently underrepresented patients who had pretreated
and clinically stable brain metastases, or who had locally advanced
disease and were not candidates for definitive chemoradiation. This
gives doctors important new data when considering Libtayo for the
varied patients and situations they treat in daily clinical
practice."
This is the third approval for Libtayo and follows a Priority
Review by the FDA, which is reserved for medicines that represent
significant improvements in safety or efficacy in treating serious
conditions. Earlier this month, Libtayo was approved as the
first immunotherapy 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, with full
approval granted for locally advanced disease and accelerated
approval granted for metastatic disease. In 2018, Libtayo was the
first systemic treatment approved for adults with advanced
cutaneous squamous cell carcinoma (CSCC) that is locally advanced
or metastatic and who are not candidates for curative surgery or
curative radiation. 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 an impressive level of efficacy in
advanced NSCLC with at least 50% PD-L1 expression in its pivotal
trial," said Ahmet Sezer, M.D.,
Professor in the Department of Medical Oncology at Başkent
University in Adana, Turkey and a
trial investigator. "As published in The Lancet, in a
prespecified analysis in the subset of patients proven to have
PD-L1 expression of at least 50%, Libtayo reduced the risk of death
by 43% compared to chemotherapy. This was achieved with a greater
than 70% crossover rate to Libtayo following disease progression on
chemotherapy, as well as the largest population of patients with
pretreated and clinically stable brain metastases among advanced
NSCLC pivotal trials to date."
The data supporting the Libtayo approval are based on an
analysis of 710 patients who were randomized to receive treatment
in a Phase 3 trial; eligible patients were intended to have PD-L1
expression of ≥50%. In this patient population, Libtayo reduced the
risk of death by 32% compared to chemotherapy, with additional
efficacy results as follows:
Endpoints
|
Libtayo
350 mg every 3
weeks
N=356
|
Chemotherapy
N=354
|
Overall Survival
(OS)
|
Median (95%
Confidence Interval
[CI])a
|
22 months
(18 months to not
evaluable)
|
14 months
(12 to 19
months)
|
Hazard ratio (95%
CI)b
|
0.68
(0.53-0.87)
|
p-value
|
0.0022
|
Progression-free
Survival (PFS) per Blinded Independent Central Review
(BICR)
|
Median (95%
CI)a
|
6.2 months
(4.5 to 8.3
months)
|
5.6 months
(4.5 to 6.1
months)
|
Hazard ratio (95%
CI)b
|
0.59
(0.49-0.72)
|
p-value
|
<0.0001
|
a Based on Kaplan-Meier method
b Based on
stratified proportional hazards model
Due to PD-L1 testing issues, an additional prespecified analysis
was performed in 563 patients with proven PD-L1 expression of ≥50%,
according to the FDA-approved assay, and is described in the
updated labeling of the FDA-approved assay (and also recently
published in The Lancet). This analysis showed that
Libtayo reduced the risk of death by 43% compared to chemotherapy,
with additional efficacy results as follows:
Endpoints
|
Libtayo
350 mg every 3
weeks
N=283
|
Chemotherapy
N=280
|
OS
|
Median (95%
CI)a
|
not
reached
(18 months to not
evaluable)
|
14 months
(11 to 18
months)
|
Hazard ratio (95%
CI)b
|
0.57
(0.42-0.77)
|
p-value
|
0.0002
|
PFS
|
Median (95%
CI)a
|
8 months
(6 to 9
months)
|
6 months
(5 to 6
months)
|
Hazard ratio (95%
CI)b
|
0.54
(0.43-0.68)
|
p-value
|
<0.0001
|
NOTE: The analysis was conducted in a subset of the
randomized population that excluded 147 patients whose tumors could
not be retested or were later found to have <50% PD-L1
expression.
a Based on Kaplan-Meier method
b
Based on stratified proportional hazards model
Safety was assessed in 355 patients in the Libtayo group (median
duration of exposure: 27 weeks; range: 9 days to 115 weeks) and 342
patients in the chemotherapy group (median duration of exposure: 18
weeks; range: 18 days to 87 weeks). Adverse reactions that occurred
more commonly in the Libtayo group and in at least 10% of patients
were rash (15% Libtayo, 6% chemotherapy) and cough (11% Libtayo, 8%
chemotherapy). The most frequent serious adverse reactions in at
least 2% of patients were pneumonia (5% Libtayo, 6% chemotherapy)
and pneumonitis (2% Libtayo, 0% chemotherapy). Treatment was
permanently discontinued due to adverse reactions in 6% of Libtayo
patients; adverse reactions 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 developed Libtayo to deliver clinically meaningful benefits
to patients suffering from a diverse range of cancers and to
establish a foundation for potential future immunotherapy
combinations. Today's approval continues to support this vision,"
said Israel Lowy, M.D., Ph.D.,
Senior Vice President, Translational and Clinical Sciences,
Oncology at Regeneron. "Libtayo has already changed the treatment
paradigm for certain patients with advanced cutaneous squamous cell
carcinoma and is poised to do the same for advanced basal cell
carcinoma. Now, Libtayo has the opportunity to make a meaningful
difference for the many U.S. patients battling advanced non-small
cell lung cancer. Libtayo is being investigated in a variety of
settings, and we hope to share updates later this year on our
pivotal trials in cervical cancer and in combination with
chemotherapy in advanced 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, with 75% of these cases diagnosed in
advanced stages and an estimated 25% to 30% of cases expected to
test positive for PD-L1 in ≥50% of tumor cells.
"With this third approval for Libtayo, we are proud to deliver
on our ambition to bring our PD-1 inhibitor to patients in need
with difficult-to-treat cancers, such as advanced non-small cell
lung cancer," said Peter C. Adamson,
M.D., Global Development Head, Oncology and Pediatric Innovation at
Sanofi. "As the leading cause of cancer deaths globally, the need
for additional therapeutic options in advanced NSCLC is clear.
Libtayo allows physicians to further optimize treatment of these
patients whose tumors have high expression of PD-L1. We thank
all of the trial investigators, patients and their caregivers who
helped make this milestone possible."
About the Phase 3 Trial Supporting Approval
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 advanced NSCLC who tested positive
for PD-L1 in ≥50% of tumor cells and without EGFR, ALK or ROS1
aberrations. PD-L1 expression was confirmed using the Agilent Dako
PD-L1 IHC 22C3 pharmDx kit. The primary endpoints were OS and PFS,
and secondary endpoints included overall response rate, duration of
response and quality of life.
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. Enrolled patients included those
with disease characteristics frequently underrepresented in pivotal
advanced NSCLC trials. Among them, 12% had pre-treated and
clinically stable brain metastases and 16% had locally advanced
NSCLC that was not a candidate for definitive chemoradiation.
Importantly, patients whose disease progressed in the trial were
able to change their therapy: those assigned to chemotherapy were
allowed to crossover to Libtayo treatment following disease
progression, while those assigned to Libtayo monotherapy were
allowed to combine Libtayo treatment with 4 to 6 cycles of
chemotherapy following disease progression. There was a >70%
crossover rate to Libtayo following disease progression on
chemotherapy.
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.
Across all of its approved indications, the recommended dose of
Libtayo is 350 mg administered as an intravenous infusion over 30
minutes every three weeks, until disease progression or
unacceptable toxicity. Libtayo is available as a single-dose 350 mg
vial.
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.
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. 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. Yancopoulos and his
team have used VelocImmune technology 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.
About the Libtayo Development Program
The European
Medicines Agency is assessing regulatory submissions for Libtayo in
advanced NSCLC with ≥50% PD-L1 expression and locally advanced BCC
following treatment with an HHI. Decisions by the European
Commission on these submissions are expected by mid-2021.
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.
Libtayo is being jointly developed by Sanofi and Regeneron under
a global collaboration agreement.
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.
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, 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
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Regeneron
Contacts:
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Sanofi
Contacts:
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Media
Relations
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Media
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Tel: +1
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Eva
Schaefer-Jansen
|
Tel: +1
914-847-5443
|
Arnaud
Delepine
|
vesna.tosic@regeneron.com
|
Yvonne
Naughton
|
|
|
|
Investor Relations
North America
|
|
Felix
Lauscher
|
|
Fara
Berkowitz
|
|
Suzanne
Greco
|
|
|
|
IR main
line:
|
|
Tel: +33 (0)1 53 77
45 45
|
|
investor.relations@sanofi.com
|
|
https://www.sanofi.com/en/investors/contact
|
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content:http://www.prnewswire.com/news-releases/fda-approves-libtayo-cemiplimab-rwlc-monotherapy-for-patients-with-first-line-advanced-non-small-cell-lung-cancer-with-pd-l1-expression-of-50-301232638.html
SOURCE Regeneron Pharmaceuticals, Inc.