TARRYTOWN, N.Y. and
PARIS, March 15, 2021 /PRNewswire/ --
Libtayo is the first immunotherapy to demonstrate improved
overall survival in patients with cervical cancer, reducing the
risk of death by 31% compared to chemotherapy
Trial enrolled patients with advanced cervical cancer
regardless of PD-L1 status
Fourth cancer type where Libtayo has positive pivotal data;
first-in-class survival results in cervical cancer follow
first-in-class pivotal results in advanced BCC and advanced
CSCC
Regulatory submissions planned in 2021
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi
today announced positive results demonstrating an overall survival
(OS) benefit from the Phase 3 trial investigating the PD-1
inhibitor Libtayo® (cemiplimab) monotherapy compared to
chemotherapy, in patients previously treated with chemotherapy
whose cervical cancer is recurrent or metastatic. The trial will be
stopped early based on a unanimous recommendation by the
Independent Data Monitoring Committee (IDMC), and the data will
form the basis of regulatory submissions in 2021.
"Libtayo monotherapy is the first medicine to demonstrate an
improvement in overall survival in women with recurrent or
metastatic cervical cancer following progression on platinum-based
chemotherapy in a Phase 3 trial," said Krishnansu S. Tewari, M.D.,
Professor and Director of the Division of Gynecologic Oncology at
the University of California, Irvine
and a trial investigator. "This landmark clinical achievement will
bring hope to women with advanced cervical cancer who are often
younger than patients with other cancers. This is reflected in this
trial where the average age was 51."
This is the largest Phase 3 randomized clinical trial in
advanced cervical cancer, and included women (median age: 51 years)
with either squamous cell carcinoma or adenocarcinoma. Patients
were randomized to receive Libtayo monotherapy (350 mg every 3
weeks) or an investigator's choice of commonly used chemotherapy
(pemetrexed, vinorelbine, topotecan, irinotecan or gemcitabine).
Compared to chemotherapy, patients receiving Libtayo
experienced:
- Total population: 31% reduced risk of death
-
- Median 12.0 months survival for Libtayo (n=304) compared to 8.5
months for chemotherapy (n=304); hazard ratio (HR): 0.69; 95%
confidence interval (CI): 0.56-0.84 (p<0.001)
- Squamous cell carcinoma: 27% reduced risk of
death
-
- Median 11.1 months survival for Libtayo (n=239) compared to 8.8
months for chemotherapy (n=238); HR: 0.73; 95% CI: 0.58-0.91
(p=0.003)
- Adenocarcinoma: 44% reduced risk of death
-
- Median 13.3 months survival for Libtayo (n=65) compared to 7.0
months for chemotherapy (n=66); HR: 0.56; 95% CI: 0.36-0.85
(p<0.005; not adjusted for multiplicity)
The primary endpoint for the trial was OS, analyzed first among
patients with squamous cell carcinoma, then in the total
population. Per a protocol-specified interim analysis, the IDMC
reviewed OS data when approximately 85% of events had occurred
among patients with squamous cell carcinoma. Based on the highly
significant effect on OS among these patients, the IDMC recommended
stopping the trial. Detailed results will be presented at an
upcoming medical meeting. The use of Libtayo in cervical cancer is
investigational and has not been fully reviewed by any regulatory
authority.
No new Libtayo safety signals were observed. Safety was assessed
in patients who received at least 1 dose of study treatment: 300
patients in the Libtayo group (median duration of exposure: 15
weeks; range: 1-101 weeks) and 290 patients in the chemotherapy
group (median duration of exposure: 10 weeks; range: 1-82 weeks).
Adverse events (AEs) were observed in 88% of Libtayo patients and
91% of chemotherapy patients, with serious AEs occurring in 30% of
Libtayo patients and 27% of chemotherapy patients. The 5 most
common AEs were anemia (25% Libtayo, 45% chemotherapy), nausea (18%
Libtayo, 33% chemotherapy), fatigue (17% Libtayo, 16%
chemotherapy), vomiting (16% Libtayo, 23% chemotherapy) and
constipation (15% Libtayo, 20% chemotherapy). Other AEs that
occurred more often in the Libtayo group and in at least 10% of
patients were fatigue (17% Libtayo, 16% chemotherapy), urinary
tract infections (12% Libtayo, 9% chemotherapy), back pain (11%
Libtayo, 9% chemotherapy) and arthralgia (10% Libtayo, 3%
chemotherapy). Discontinuations due to AEs occurred in 8% of
Libtayo patients and 5% of chemotherapy patients.
"Recurrent or metastatic cervical cancer is notoriously
difficult to treat and has no approved standard of care after
first-line chemotherapy," said Israel
Lowy, M.D., Ph.D., Senior Vice President, Translational and
Clinical Sciences, Oncology, at Regeneron. "This trial, which
enrolled patients regardless of their PD-L1 status, demonstrated
that Libtayo helped patients with recurrent or metastatic cervical
cancer live longer after progression on prior chemotherapy. This is
the fourth patient population in which Libtayo has shown clinical
benefit and we look forward to submitting the results to regulatory
authorities later this year."
Today's announcement follows the recent U.S. approval of
Libtayo monotherapy for certain patients with advanced non-small
cell lung cancer (NSCLC) whose tumors have high PD-L1 expression.
The FDA also recently authorized the use of Libtayo as the
first immunotherapy indicated for patients with basal cell
carcinoma (BCC) previously treated with a hedgehog pathway
inhibitor (HHI) or for whom an HHI is not appropriate, whose cancer
is either locally-advanced (full approval) or metastatic
(accelerated approval). In 2018, Libtayo was approved as the
first systemic treatment for certain patients with advanced
cutaneous squamous cell carcinoma (CSCC).
"We are committed to developing therapies for cancers with high
unmet needs including patients with advanced cervical cancer," said
Peter C. Adamson, M.D., Global
Development Head, Oncology and Pediatric Innovation at Sanofi.
"Combined with data from our non-melanoma skin cancer and lung
cancer studies, these data contribute to the growing evidence
demonstrating the significant potential of Libtayo to treat a
spectrum of difficult-to-treat cancers."
About the Phase 3 Trial
This open-label, randomized,
multi-center, Phase 3 trial investigated Libtayo monotherapy versus
an investigator's choice of chemotherapy in patients with recurrent
or metastatic cervical cancer that has progressed on platinum-based
chemotherapy. Patients were allowed to enroll regardless of PD-L1
expression status with 78% of patients having squamous cell
carcinoma and 22% having adenocarcinoma. The trial included women
from 14 countries: the U.S., Japan, Taiwan, South
Korea, Canada, Russia, Poland, Spain, Brazil, Australia, the UK, Italy, Greece
and Belgium.
About Cervical Cancer
Cervical cancer is the fourth
leading cause of cancer death in women worldwide and is most
frequently diagnosed in women between the ages of 35 and
44. Almost all cases are caused by human papillomavirus (HPV)
infection, with approximately 80% classified as squamous cell
carcinoma (arising from cells lining the bottom of the cervix) and
the remainder largely adenocarcinomas (arising from glandular cells
in the upper cervix). Cervical cancer is often curable when
detected early and effectively managed, but treatment options are
more limited in advanced stages.
It is estimated that there are approximately 570,000 women
diagnosed with cervical cancer worldwide each year. In the U.S.
there are 14,500 new patients diagnosed annually and approximately
4,000 women die each year.
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., Libtayo is approved for certain patients with
advanced stages of CSCC, BCC and NSCLC with ≥50% PD-L1 expression.
Outside of the U.S., Libtayo is approved for certain patients with
advanced CSCC in the European Union and six other countries,
including Australia, Brazil, the United
Kingdom and Canada.
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 FDA. Outside of the U.S., the generic name
for Libtayo in its approved indication is cemiplimab.
About Regeneron's VelocImmune®
Technology
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. Dr. Yancopoulos and his team have used
VelocImmune technology to create multiple antibodies
including Libtayo® (cemiplimab-rwlc),
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 extensive
clinical program for Libtayo is focused on difficult-to-treat
cancers. The European Medicines Agency is assessing regulatory
submissions for Libtayo monotherapy in advanced NSCLC with ≥50%
PD-L1 expression and locally advanced BCC following treatment with
an HHI, with European Commission decisions expected by
mid-2021.
Libtayo monotherapy is being investigated in trials in adjuvant
CSCC and neoadjuvant CSCC, 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 Regeneron and Sanofi 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 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 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, hematology, 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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property of other parties and pending or future litigation relating
thereto (including without limitation the patent litigation and
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(aflibercept) Injection, Dupixent®
(dupilumab), Praluent® (alirocumab), and
REGEN-COVTM (casirivimab and imdevimab)), other
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Regeneron
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Media
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Tel: +1
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Investor Relations
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SOURCE Regeneron Pharmaceuticals, Inc.