Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the
latest clinical data in early- and late-stage cancers from its
oncology pipeline will be presented at the European Society for
Medical Oncology (ESMO) Congress 2023 from October 20 to 24 in
Madrid, Spain. The presentations demonstrate the role of Libtayo®
(cemiplimab) as both a monotherapy and a backbone of novel
investigational combinations for various solid tumors.
“Our data presentations at ESMO underscore Regeneron’s ability
to apply a deep understanding of cancer biology, genetics and the
immune system to advance the development of meaningful combinations
for cancer types that have high unmet need,” said Israel Lowy,
Senior Vice President, Translational and Clinical Oncology at
Regeneron. “Notably, we are presenting the first survival data for
neoadjuvant Libtayo therapy in cutaneous squamous cell carcinoma
and the first results for Libtayo in combination with ubamatamab,
our investigational MUC16xCD3 bispecific antibody, in recurrent
ovarian cancer. Beyond ESMO, we are excited by recent progress
across our oncology portfolio, including FDA Fast Track Designation
for fianlimab (LAG-3) plus Libtayo in melanoma. We look forward to
sharing more with the global oncology community as we deliver on
our promise to improve the lives of those impacted by cancer.”
Among Regeneron’s ESMO presentations is an oral highlighting
one-year survival outcomes, including event-free survival, from a
Phase 2 trial of Libtayo in neoadjuvant CSCC. The primary analysis
was shared at last year’s ESMO meeting.
Regeneron will also debut Phase 1 dose-escalation results for
its investigational combination of Libtayo and ubamatamab in
patients with heavily pretreated recurrent ovarian cancer in a
poster session. A Phase 2 expansion portion of the study is
underway. Ubamatamab is a CD3-targeting bispecific designed to
bridge MUC16 on cancer cells with CD3-expressing T cells to
facilitate local T-cell activation.
Additional presentations at ESMO include subgroup analyses of
Libtayo in advanced non-small cell lung cancer (NSCLC), focusing on
such populations as squamous cell carcinoma and patients with
varying levels of PD-L1 expression.
Regeneron presentations at ESMO:
Medicine |
Abstract title |
Abstract |
Lead Author |
Presentation date/time (all
CEST) |
Skin cancer |
Libtayo |
A Phase 2 Study of Neoadjuvant Cemiplimab for Stage II to IV
Cutaneous Squamous Cell Carcinoma (CSCC): One-year Follow-up |
#1088MO |
Neil D. Gross, M.D., F.A.C.S. |
Saturday, October 21, 2023; 14:45 – 16:15 |
Libtayo |
Cemiplimab Versus Historical Systemic Treatments for Locally
Advanced or Metastatic Cutaneous Squamous Cell Carcinomas: Results
From the French Study TOSCA |
#1140P |
Emilie Gerard, M.D. |
Sunday, October 22, 2023; 09:00 – 17:00 |
Ovarian cancer |
Ubamatamab, Libtayo |
Ubamatamab (MUC16xCD3 Bispecific Antibody) with Cemiplimab
(Anti-PD-1 Antibody) in Recurrent Ovarian Cancer: Phase 1
Dose-Escalation Study |
#754P |
Roisin E O'Cearbhaill, M.D. |
Sunday, October 22, 2023; 09:00 – 17:00 |
Lung cancer |
Libtayo, chemotherapy |
Patient-reported Outcomes (PROs) with Cemiplimab Plus Chemotherapy
(CEMI + CHEMO) for First-line Treatment of Advanced Non-small Cell
Lung Cancer (aNSCLC): PD-L1 Level Subgroups in EMPOWER-Lung 3 |
#1443P |
Miranda Gogishvili, M.D. |
Monday, October 23, 2023; 09:00 –17:00 |
Libtayo, chemotherapy |
Cemiplimab Plus Chemotherapy Versus Chemotherapy in Non-small Cell
Lung Cancer with PD-L1 ≥1%: EMPOWER-Lung 3 Results |
#1495P |
Ana Baramidze, M.D., Ph.D. |
Monday, October 23, 2023; 09:00 –17:00 |
Libtayo |
Cemiplimab for Advanced Non-small Cell Lung Cancer: Squamous
Subgroup Analysis for EMPOWER-Lung 1 and 3 |
#1438P |
Tanta Makharadze, M.D. |
Monday, October 23, 2023; 09:00 –17:00 |
Libtayo, BNT116 |
A Phase 2 Study of Cemiplimab Plus BNT116 Versus Cemiplimab Alone
in First-line Treatment of Patients with Advanced Non-small Cell
Lung Cancer with PD-L1 Expression ≥50% |
#1503TiP |
Mark Awad, M.D., Ph.D. |
Monday, October 23, 2023; 09:00 –17:00 |
The potential uses of Libtayo for neoadjuvant CSCC as well as
the combinations of ubamatamab and Libtayo, and BNT116 and Libtayo
described above are investigational, and their safety and efficacy
have not been fully evaluated by any regulatory authority.
About Regeneron in CancerWe aspire to turn
revolutionary discoveries into medicines that can transform the
lives of those impacted by cancer. Our team around the world is
driven to solve the needs and challenges of those affected by one
of the most serious diseases of our time.
Backed by our legacy of scientific innovation and a deep
understanding of biology, genetics and the immune system, we’re
pursuing potential therapies across more than 30 types of solid
tumors and blood cancers. Our cancer strategy is powered by
cutting-edge technologies and therapies that can be flexibly
combined to investigate potentially transformative treatments for
patients. Oncology assets in clinical development comprise nearly
half of Regeneron’s pipeline, and include checkpoint inhibitors,
bispecific antibodies and costimulatory bispecific antibodies. Our
approved PD-1 inhibitor Libtayo serves as the backbone of many of
our investigational combinations.
To complement our extensive in-house capabilities, we
collaborate with patients, healthcare providers, governments,
biopharma companies and each other to further our shared goals.
Together, we are united in the mission to serve as a beacon of
transformation in cancer care.
About LibtayoLibtayo is a fully human
monoclonal antibody targeting the immune checkpoint receptor PD-1
on T cells and was invented using Regeneron's proprietary
VelocImmune® technology. 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. and other countries,
Libtayo is indicated in certain patients with advanced basal cell
carcinoma (BCC), advanced CSCC and advanced NSCLC, as well as in
advanced cervical cancer in the European Union (EU), Canada and
Brazil. As of July 1, 2022, Regeneron is responsible for the
development and marketing of Libtayo globally. In the EU, Libtayo
is currently marketed by Sanofi on Regeneron’s behalf over the
course of a defined transition period.
In the U.S., the generic name for Libtayo in its approved
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). Outside of the U.S., the generic
name of Libtayo in its approved indications is cemiplimab.
The extensive clinical program for Libtayo is focused on
difficult-to-treat cancers. Libtayo is currently being investigated
in trials as a monotherapy, as well as 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.
U.S. FDA-approved IndicationsLibtayo 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.
- People with a type of skin cancer called basal cell carcinoma
(BCC) when your BCC cannot be removed by surgery (locally advanced
BCC) or when it has spread (metastatic BCC) and have received
treatment with hedgehog pathway inhibitor (HHI), or cannot receive
treatment with a HHI.
- Adults with a type of lung cancer called NSCLC:
- Libtayo may be used in combination with chemotherapy that
contains a platinum medicine 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 does not have an abnormal
“EGFR”, “ALK” or “ROS1” gene.
- Libtayo may be used alone 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.
IMPORTANT SAFETY INFORMATION
FOR U.S. PATIENTS
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 received radiation treatment to your chest area
- 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 babyFemales 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 when used alone include muscle
or bone pain, tiredness, rash, and diarrhea. The most common side
effects of Libtayo when used in combination with
platinum-containing chemotherapy include hair loss, muscle or bone
pain, nausea, tiredness, numbness, pain, tingling, or burning in
your hands or feet, and decreased appetite. 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 at 1-877-542-8296.
Please see full Prescribing
Information,
including Medication
Guide.
About
Regeneron's VelocImmune TechnologyRegeneron'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 a substantial
proportion of all original, FDA-approved or authorized fully human
monoclonal antibodies. This includes REGEN-COV® (casirivimab
and imdevimab), Dupixent® (dupilumab), Libtayo®,
Praluent® (alirocumab), Kevzara® (sarilumab),
Evkeeza® (evinacumab-dgnb), Inmazeb® (atoltivimab,
maftivimab and odesivimab-ebgn) and Veopoz™ (pozelimab-bbfg).
About RegeneronRegeneron is a leading
biotechnology company that invents, develops and commercializes
life-transforming medicines for people with serious diseases.
Founded and led for 35 years by physician-scientists, our unique
ability to repeatedly and consistently translate science into
medicine has led to numerous 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, 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 more information, please
visit www.Regeneron.com or follow Regeneron on
LinkedIn.
Forward-Looking Statements and Use of Digital
MediaThis 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 statements, although not all forward-looking
statements contain these identifying words. These statements
concern, and these risks and uncertainties include, among others,
the nature, timing, and possible success and therapeutic
applications of products marketed or otherwise commercialized by
Regeneron and/or its collaborators or licensees (collectively,
“Regeneron’s Products”) and product candidates being developed by
Regeneron and/or its collaborators or licensees (collectively,
“Regeneron’s Product Candidates”) and research and clinical
programs now underway or planned, including without limitation
Libtayo® (cemiplimab) as a monotherapy or in combination with
ubamatamab (an investigational MUC16xCD3 bispecific antibody) or
the other conventional or novel therapeutic approaches discussed or
referenced in this press release, odronextamab (bispecific antibody
targeting CD20 and CD3), and fianlimab (antibody to LAG-3); the
likelihood, timing, and scope of possible regulatory approval and
commercial launch of Regeneron’s Product Candidates and new
indications for Regeneron’s Products, including Libtayo as a
neoadjuvant monotherapy for the treatment of cutaneous squamous
cell carcinoma, Libtayo in combination with ubamatamab for the
treatment of recurrent ovarian cancer, odronextamab for the
treatment of lymphoma, and fianlimab in combination with Libtayo
for the treatment of melanoma; 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 ubamatamab, odronextamab, and
fianlimab); the ability of Regeneron’s collaborators, licensees,
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 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 (such as
ubamatamab, odronextamab, and fianlimab) 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; 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
conducted by Regeneron and/or its collaborators or licensees may be
replicated 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, producing, and selling products; the ability of
Regeneron to meet 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 and Bayer
(or their respective affiliated companies, as applicable) to be
cancelled or terminated; the impact of public health outbreaks,
epidemics, or pandemics (such as the COVID-19 pandemic) on
Regeneron's business; 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 and REGEN-COV® (casirivimab and 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, 2022 and its Form 10-Q for the
quarterly period ended June 30, 2023. 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
social media outlets to publish important information about the
Company, including information that may be deemed material to
investors. Financial and other information about Regeneron is
routinely posted and is accessible on Regeneron's media and
investor relations website (https://investor.regeneron.com) and its
LinkedIn page
(https://www.linkedin.com/company/regeneron-pharmaceuticals).
Contacts:Media
Relations Taylor
Ramsey Tel: +1
914-409-2381taylor.ramsey@regeneron.com |
Investor
RelationsVesna TosicTel: +1
914-847-5443vesna.tosic@regeneron.com |
Regeneron Pharmaceuticals (NASDAQ:REGN)
Gráfico Histórico do Ativo
De Mar 2024 até Abr 2024
Regeneron Pharmaceuticals (NASDAQ:REGN)
Gráfico Histórico do Ativo
De Abr 2023 até Abr 2024