TARRYTOWN, N.Y., May 19, 2021 /PRNewswire/ --
Presentations include first positive clinical data for the
fianlimab (LAG-3 inhibitor) and Libtayo combination in advanced
melanoma
Regeneron will host an investor webcast on Monday, June 7 to provide further updates across
its oncology portfolio
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today
announced the company will share a range of presentations for its
PD-1 inhibitor Libtayo® (cemiplimab-rwlc) and broader
oncology portfolio at the 2021 American Society of Clinical
Oncology (ASCO) Annual Meeting from June 4-8, taking
place virtually. Presentations include new clinical data and
in-depth analyses on the impact of Libtayo in several advanced
cancers, including non-small cell lung cancer (NSCLC), cutaneous
squamous cell carcinoma (CSCC), basal cell carcinoma (BCC) and
melanoma.
"Following our presentation of updated, positive cervical data
at the ESMO Virtual Plenary, we look forward to providing an
overview of the maturing experience with Libtayo across a range of
cancers at ASCO," said Israel Lowy,
M.D., Ph.D., Senior Vice President, Translational and Clinical
Sciences, Oncology, at Regeneron. "Presentations include a new
post-hoc analysis of our pivotal Libtayo trial for advanced
non-small cell lung cancer in a subset of patients with brain
metastases, as well as new data from a prospective real-world trial
in immunocompromised or immunosuppressed patients with advanced
cutaneous squamous cell carcinoma. We will also share presentations
showing the impact of Libtayo on quality of life in multiple
cancers, and for the first time, positive results for Libtayo in
combination with our investigational LAG-3 inhibitor fianlimab in
advanced melanoma."
Investigator-assessed results from two expansion cohorts of a
Phase 1 trial investigating fianlimab (REGN3767) and Libtayo in
advanced melanoma were published by ASCO today. Efficacy was
greatest in PD-1 inhibitor naïve patients, who experienced a 64%
objective response rate (21 of 33 patients; 3 complete responses,
18 partial responses), and the median progression-free survival and
median duration of response had not yet been reached.
Among 48 patients receiving the fianlimab and Libtayo
combination, the most common adverse events (AEs) were fatigue
(n=15; 31%) and rash (n=11; 23%). Grade 3 or higher AEs occurred in
35% (n=17) of patients, with 23% (n=11) of these events classified
as serious. Treatment discontinuations due to an AE occurred in 8%
(n=4) of patients. Updated efficacy and safety data will be
presented during a poster discussion session available on-demand
starting Friday, June 4 at
9:00 a.m. ET (Abstract 9515).
Earlier this year, Libtayo monotherapy was approved in the
U.S. for certain patients with NSCLC whose tumors have high PD-L1
expression and no EGFR, ALK or ROS1 aberrations. The FDA also
recently approved the use of Libtayo as the first
immunotherapy indicated for patients with 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 CSCC. Libtayo is being jointly developed by
Regeneron and Sanofi under a global collaboration
agreement.
Investor Webcast Information
Regeneron will host a conference call and simultaneous webcast to
share updates on the Company's oncology portfolio on Monday,
June 7 at 4:30 p.m. ET. To access
this call, dial (888) 660-6127 (U.S.) or (973) 890-8355
(International), conference ID 7569618. A link to the webcast may
be accessed from the 'Investors and Media' page of Regeneron's
website at http://investor.regeneron.com/events.cfm. A replay of
the conference call and webcast will be archived on the Company's
website for at least 30 days.
Libtayo joint presentations with Sanofi at
ASCO
NSCLC
- Cemiplimab monotherapy as first-line (1L) treatment of patients
with brain metastases from advanced non-small cell lung cancer
(NSCLC) with programmed cell death-ligand 1 (PD-L1) ≥50%;
EMPOWER-Lung 1 subgroup analysis (Abstract 9085; Mustafa
Özgüroğlu, M.D.; Poster Session)
- Patient-reported symptoms, functioning, and quality of life
(QoL) in patients treated with cemiplimab monotherapy for
first-line treatment of advanced NSCLC with PD-L1 ≥50%: Results
from EMPOWER-Lung 1 study (Abstract 9078; Mahmut Gümüş, M.D.;
Poster Session)
- Network meta-analysis (NMA) of immuno-oncology (IO) monotherapy
(mono) as first-line (1L) treatments (txs) for advanced non-small
cell lung cancer (NSCLC) with PD-L1 expression ≥50% (Abstract
e21091; Nick Freemantle, Ph.D.; Online Publication)
- Budget impact (BI) analysis of cemiplimab for first-line (1L)
advanced non-small cell lung cancer (NSCLC) with programmed cell
death-ligand 1 (PD-L1) ≥50% in the United
States (Abstract e18817; Andreas Kuznik, Ph.D.; Online
Publication)
BCC
- Health-related quality of life (HRQoL) in patients (pts) with
locally advanced basal cell carcinoma (laBCC) treated with
cemiplimab: analysis of a phase II, open-label clinical trial
(Abstract 9566; Alexander J. Stratigos, M.D.; Poster
Session)
- Frequency, characteristics, and subsequent treatment (Tx) of
real-world patients (pts) who discontinue hedgehog inhibitors (HHI)
as first-line (1L) systemic Tx for advanced basal cell carcinoma
(aBCC) (Abstract e18740; C. Lance
Cowey, M.D.; Online Publication)
- Outcomes in patients (pts) with advanced basal cell carcinoma
(aBCC) who discontinued hedgehog inhibitors (HHI) as first-line
(1L) systemic treatment (Tx) in a US community oncology setting: A
retrospective observational study (Abstract e18742; C.
Lance Cowey, M.D.; Online
Publication)
- Budget impact (BI) analysis of cemiplimab-rwlc for advanced
basal cell carcinoma (BCC) after hedgehog inhibitor (HHI) therapy
in the United States (Abstract
e18830; Eleanor Paul; Online Publication)
CSCC
- Checkpoint inhibition in immunosuppressed or immunocompromised
patients with advanced cutaneous squamous cell carcinoma (CSCC):
Data from prospective CemiplimAb-rwlc Survivorship and Epidemiology
(C.A.S.E.) study (Abstract 9547; Guilherme Rabinowits,
M.D.; Poster Session)
Additional Regeneron presentations at ASCO
Libtayo
in combination with fianlimab
- Clinical activity of fianlimab (REGN3767), a human anti-LAG-3
monoclonal antibody, combined with cemiplimab (anti-PD-1) in
patients (pts) with advanced melanoma (Abstract 9515; Omid
Hamid, M.D.; Poster Discussion)
REGN5668 (MUC16xCD28)
- A Phase I/II, multicenter, open-label study of REGN5668 (mucin
[MUC]16 x CD28 bispecific antibody [bsAb]) with cemiplimab
(programmed death [PD]-1 Ab) or REGN4018 (MUC16 x CD3 bsAb) in
recurrent ovarian cancer (rOVCA) (Abstract TPS5602; Ira Winer,
M.D., Ph.D.; Trial-in-progress Poster)
The use of fianlimab in combination with Libtayo for advanced
melanoma is investigational, and its safety and efficacy have not
been evaluated by any regulatory authority.
About Regeneron in Oncology
At Regeneron, we're
applying more than three decades of scientific innovation to
develop paradigm-changing therapies for patients with cancer.
Fusing our deep expertise in biology with our proprietary
VelociSuite® technologies, we have contributed
landmark cancer research to the field and are pioneering
first-in-class investigational treatments through a growing
pipeline of more than 10 cancer therapies.
Our oncology portfolio is built around two foundational
approaches – our approved PD-1 inhibitor Libtayo and bispecific
antibodies – which are being investigated both as monotherapies and
in combination with emerging therapeutic modalities. Together, they
provide us with unique combinatorial flexibility to develop
customized and potentially synergistic treatments for a wide range
of solid tumors and blood cancers.
For more information on our clinical programs, visit
www.regeneron.com/pipeline.
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, and 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 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.
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 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, 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.
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,"
"seek," "estimate," variations of such words, and similar
expressions are intended to identify such forward-looking
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these identifying words. These statements concern, and these risks
and uncertainties include, among others, the impact of SARS-CoV-2
(the virus that has caused the COVID-19 pandemic) on Regeneron's
business and its employees, collaborators, and suppliers and other
third parties on which Regeneron relies, Regeneron's and its
collaborators' ability to continue to conduct research and clinical
programs, Regeneron's ability to manage its supply chain, net
product sales of products marketed or otherwise commercialized by
Regeneron and/or its collaborators (collectively, "Regeneron's
Products"), and the global economy; the nature, timing, and
possible success and therapeutic applications of Regeneron's
Products and product candidates being developed by Regeneron and/or
its collaborators (collectively, "Regeneron's Product Candidates")
and research and clinical programs now underway or planned,
including without limitation Libtayo® (cemiplimab) for
the treatment of non-small cell lung cancer ("NSCLC"), cutaneous
squamous cell carcinoma, basal cell carcinoma, and melanoma (in
combination with fianlimab (REGN3767)), as well as REGN5668 and
REGN4018; uncertainty of the utilization, market acceptance, and
commercial success of Regeneron's Products and Regeneron's Product
Candidates and the impact of studies (whether conducted by
Regeneron or others and whether mandated or voluntary), including
the studies discussed or referenced in this press release,
on any of the foregoing or any potential regulatory approval of
Regeneron's Products (such as Libtayo) and Regeneron's Product
Candidates (such as fianlimab (REGN3767), REGN5668, and REGN4018);
the likelihood, timing, and scope of possible regulatory approval
and commercial launch of Regeneron's Product Candidates and new
indications for Regeneron's Products, such as Libtayo in
combination with chemotherapy for advanced NSCLC irrespective of
PD-L1 expression and Libtayo 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
collaborators, suppliers, or other third parties (as applicable) to
perform manufacturing, filling, finishing, packaging, labeling,
distribution, and other steps related to Regeneron's Products and
Regeneron's Product Candidates; the ability of Regeneron to
manufacture and manage supply chains for multiple products and
product candidates; safety issues resulting from the administration
of Regeneron's Products (such as Libtayo) and Regeneron's Product
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
Candidates, including without limitation Libtayo; ongoing
regulatory obligations and oversight impacting Regeneron's
Products, research and clinical programs, and business, including
those relating to patient privacy; the availability and extent of
reimbursement of Regeneron's Products from third-party payers,
including private payer healthcare and insurance programs, health
maintenance organizations, pharmacy benefit management companies,
and government programs such as Medicare and Medicaid; coverage and
reimbursement determinations by such payers and new policies and
procedures adopted by such payers; competing drugs and product
candidates that may be superior to, or more cost effective than,
Regeneron's Products and Regeneron's Product Candidates; the extent
to which the results from the research and development programs
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in other studies and/or lead to advancement of product candidates
to clinical trials, therapeutic applications, or regulatory
approval; unanticipated expenses; the costs of developing,
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any of its financial projections or guidance and changes to the
assumptions underlying those projections or guidance; the potential
for any license, collaboration, or supply agreement, including
Regeneron's agreements with Sanofi, Bayer, and Teva Pharmaceutical
Industries Ltd. (or their respective affiliated companies, as
applicable), to be cancelled or terminated; and risks 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 with imdevimab)), other
litigation and other proceedings and government investigations
relating to the Company and/or its operations, the ultimate outcome
of any such proceedings and investigations, and the impact any of
the foregoing may have on Regeneron's business, prospects,
operating results, and financial condition. A more complete
description of these and other material risks can be found in
Regeneron's filings with the U.S. Securities and Exchange
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,
2021. Any forward-looking statements are made based on
management's current beliefs and judgment, and the reader is
cautioned not to rely on any forward-looking statements made by
Regeneron. Regeneron does not undertake any obligation to update
(publicly or otherwise) any forward-looking statement, including
without limitation any financial projection or guidance, whether as
a result of new information, future events, or otherwise.
Regeneron uses its media and investor relations website and
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Regeneron Contacts:
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SOURCE Regeneron Pharmaceuticals, Inc.