TARRYTOWN, N.Y. and
PARIS, June
25, 2021 /PRNewswire/ --
Approval based on data from the largest trial to date in
patients with advanced basal cell carcinoma previously treated with
a hedgehog pathway inhibitor
Libtayo now approved by the European Commission for three
advanced cancers
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi
today announced that the European Commission (EC) has approved the
PD-1 inhibitor Libtayo® (cemiplimab) to treat adults
with locally advanced or metastatic basal cell carcinoma (BCC) who
have progressed on or are intolerant to a hedgehog pathway
inhibitor (HHI).
BCC is the most common type of skin cancer worldwide,
representing up to 80% of non-melanoma skin cancers, and incidence
is increasing across many European countries. While the large
majority of BCCs are caught early and easily cured with surgery
and/or radiation, a small proportion of cases can develop into
advanced BCC and penetrate deeper into surrounding tissues (locally
advanced) or spread to other parts of the body (metastatic),
becoming more difficult to treat.
"Libtayo is the first immunotherapy to show a clinical benefit
in patients with advanced BCC after HHI therapy in a pivotal trial,
and with this first-in-class approval has the potential to
transform treatment for patients in Europe whose cancer has progressed despite HHI
treatment," said Israel Lowy, M.D.,
Ph.D., Senior Vice President, Translational and Clinical Sciences,
Oncology at Regeneron. "We look forward to continuing to
investigate this medicine in additional settings, with the
goal of helping more patients with difficult-to-treat cancers
around the world."
Libtayo is now approved for three advanced cancers in the
European Union, following the EC's concurrent approval of
Libtayo for the first-line treatment of adult patients with
advanced non-small cell lung cancer (NSCLC) whose tumor cells have
≥50% PD-L1 expression and no EGFR, ALK or ROS1 aberrations. In
2019, Libtayo was approved by the EC as the first treatment
for adults with metastatic or locally advanced cutaneous squamous
cell carcinoma (CSCC) who are not candidates for curative surgery
or curative radiation. Across all of its approved indications,
Libtayo had a generally consistent safety profile. Immune-mediated
adverse reactions, which may be severe or fatal, can occur in any
organ system or tissue during or after treatment with Libtayo.
The EC approval in BCC is based on data from the largest
prospective clinical trial (n=119) in patients with advanced BCC
previously treated with an HHI to date. Libtayo-treated patients
with locally advanced BCC experienced an objective response rate
(ORR) of 32% (95% confidence interval [CI]: 22-43) (25% partial
response, 7% complete response) by independent central review.
Libtayo-treated patients with metastatic BCC demonstrated an ORR of
29% (95% CI: 15-46) (26% partial response, 3% complete response) by
investigator assessment. In addition, approximately 90% of patients
across both groups had a duration of response (DOR) of 6 months or
longer per Kaplan Meier estimates,
and the median DOR has not been reached for either group. Median
duration of follow-up was 16 months for locally advanced BCC and 9
months for metastatic BCC.
Safety was assessed in 816 patients across all four Libtayo
monotherapy pivotal trials in its approved
indications. Adverse events were serious in 30%
of patients and led to permanent discontinuation in 8% of
patients. Immune–related adverse reactions occurred in 22% of
patients and led to permanent discontinuation in 4% of patients.
The most common immune-related adverse reactions were
hypothyroidism (8%), hyperthyroidism (3%), pneumonitis (3%),
hepatitis (2%), colitis (2%) and immune-related skin adverse
reactions (2%).
"Since its launch in Europe
just two years ago, Libtayo has redefined the standard of care for
advanced CSCC and has the potential to do the same in advanced
BCC," said Peter C. Adamson, M.D.,
Global Development Head, Oncology at Sanofi. "Together with
Regeneron, we're committed to addressing gaps in the treatment of
advanced forms of non-melanoma skin cancer."
About the Phase 2 Trial in Advanced BCC
The EC approval was based on data from an ongoing open-label,
multi-center, non-randomized Phase 2 trial of patients with
unresectable locally advanced BCC 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.
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. No PD-L1 or tumor mutational burden
(TMB) testing is required before starting treatment with Libtayo
for advanced BCC.
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.
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). 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 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 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
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"estimate," variations of such words, and similar expressions are
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These statements concern, and these risks and uncertainties
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employees, collaborators, and suppliers and other third parties on
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(collectively, "Regeneron's Product Candidates") and research and
clinical programs now underway or planned, including without
limitation Libtayo® (cemiplimab) for the treatment of
locally advanced or metastatic basal cell carcinoma; uncertainty of
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Candidates and the impact of studies (whether conducted by
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the study discussed in this press release, on any of the
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cancer irrespective of PD-L1 expression and as
monotherapy for advanced cervical cancer (as well as in
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approaches for both solid tumors and blood cancers); the
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serious complications or side effects in connection with the use of
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competing drugs and product candidates that may be superior to, or
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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
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the foregoing may have on Regeneron's business, prospects,
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description of these and other material risks can be found in
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Commission, including its Form 10-K for the year ended December 31, 2020 and its Form 10-Q for the
quarterly period ended March 31,
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cautioned not to rely on any forward-looking statements made by
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Regeneron
Contacts:
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Relations
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Ramsey
Tel: +1
914-409-2381
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Relations
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Tosic
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914-847-5443
vesna.tosic@regeneron.com
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Sanofi
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Arnaud
Delepine
Nathalie Pham
Investor Relations
North America
Felix
Lauscher
Fara
Berkowitz
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IR main
line:
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45 45
investor.relations@sanofi.com
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