Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the
presentation of new and updated data on multiple combination
therapies from its oncology pipeline at the European Society for
Medical Oncology Immuno-Oncology (ESMO IO) Congress 2023 from
December 6 to 8 in Geneva, Switzerland. Highlights include first
Phase 1 dose-escalation data for the investigational costimulatory
bispecific antibody REGN5668 (MUC16xCD28) in combination with PD-1
inhibitor Libtayo® (cemiplimab) showing encouraging initial
activity in patients with recurrent ovarian cancer. Additionally, a
late-breaking oral presentation will detail the first results from
a Phase 2 trial investigating neoadjuvant Libtayo in combination
with low-dose stereotactic body radiotherapy (SBRT) in patients
with early-stage hepatocellular carcinoma (HCC).
“Our ESMO IO presentations highlight the continued progress of
Regeneron’s oncology pipeline, which was strategically curated to
have the potential to offer novel and differentiated combinations
targeting several types of difficult-to-treat cancers. We look
forward to sharing first clinical data from our costimulatory
bispecific program in patients with recurrent ovarian cancer, which
is investigating a MUC16xCD28 bispecific antibody in combination
with our PD-1 inhibitor Libtayo,” said Israel Lowy, Senior Vice
President, Translational and Clinical Oncology at Regeneron. “This
is our second costimulatory bispecific program to report clinical
data, with a total of four such agents currently in the clinic, and
adds to the evidence showing that our novel CD28 costimulatory
bispecifics can potentially enhance the anti-tumor activity of
anti-PD-1 therapies in a synergistic fashion. Studies are also
underway exploring the combination of CD28 costimulatory
bispecifics with CD3 bispecifics, including REGN5668 with
ubamatamab, our MUC16xCD3 bispecific.”
Per initial results to be shared at ESMO IO, a combination of
REGN5668 with Libtayo showed early clinical activity in patients
with recurrent ovarian cancer. The trial enrolled 28
platinum-experienced patients with recurrent ovarian cancer, who
received infusions of REGN5668 once-weekly at a dose range of
0.3-300 mg, with the addition of Libtayo infusions every three
weeks beginning between day 21 and 28. At the time of initial data
cut off (July 14, 2023), 6 patients (21%) had stable disease, while
1 patient (in the 300 mg REGN5668 cohort) had an ongoing confirmed
partial response with a 59% target lesion reduction from baseline.
Dose escalation is ongoing and has included administration of
REGN5668 doses beyond 300 mg in combination with Libtayo.
The combination of REGN5668 and Libtayo demonstrated an
acceptable safety profile in 28 patients with fatigue (32%), nausea
(29%) and pain (18%) as the most common treatment-related adverse
events (TRAEs). Infusion-related reactions occurred in 7% of
patients and cytokine release syndrome occurred in 11% of patients
and were all grade 1 or 2. There was one instance of a TRAE that
was grade 3, which was fatigue. As of data cut off, there were no
dose-limiting toxicities or adverse events resulting in death or
treatment discontinuation. Dose escalation is continuing in order
to define an optimal dose for expansion cohorts.
Regeneron presentations at ESMO IO:
Medicine(s) |
Abstract Title |
Abstract |
Lead Author |
Presentation date/time (all CET) |
|
Libtayo, REGN5668 |
REGN5668 (MUC16xCD28 bispecific antibody) with cemiplimab
(anti-PD-1 antibody) in recurrent ovarian cancer: Phase 1
dose-escalation study |
#127P |
John L. Hayes, M.D., Ph.D. |
Thursday, December 7, 2023; 12PM–1PM CET |
|
Libtayo, chemotherapy |
Patient-reported outcomes (PROs) of cemiplimab + chemotherapy in
advanced non-small cell lung cancer (NSCLC): EMPOWER-lung 3 liver
metastases subpopulation |
#783P |
Ana Baramidze, M.D., Ph.D. |
Thursday, December 7, 2023; 12PM–1PM CET |
|
Libtayo, SBRT |
Low-dose stereotactic body radiotherapy prior to pre-operative
cemiplimab for patients with resectable hepatocellular
carcinoma |
#LBA4 |
Thomas Marron, M.D., Ph.D. |
Thursday, December 7, 9:25AM–9:30AM CET |
The potential uses of Libtayo and REGN5668 described above are
investigational, and their safety and efficacy in these uses have
not been fully evaluated by any regulatory authority. REGN5668 is
not currently approved for use in any indication.
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 cutaneous squamous cell carcinoma (CSCC)
and advanced non-small cell lung cancer (NSCLC), as well as in
advanced cervical cancer in the European Union, Canada
and Brazil. As of July 1, 2022, Libtayo is developed and
marketed globally by Regeneron.
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 indication 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 Indications 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.
- 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 a hedgehog pathway inhibitor (HHI), or cannot
receive treatment with a HHI.
- Adults with a type of lung cancer called non-small cell lung
cancer (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 or
life-threatening. Signs and symptoms of infusion reactions
may include: nausea, vomiting, 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 to 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
tiredness, muscle or bone pain, rash, diarrhea, and low levels of
red blood cells (anemia). 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, Regeneron's
unique ability to repeatedly and consistently translate science
into medicine has led to numerous FDA-approved treatments and
product candidates in development, almost all of which were
homegrown in Regeneron's laboratories. Regeneron's 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 its
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 Regeneron, 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) in combination with REGN5668 (MUC16xCD28
costimulatory bispecific antibody), Libtayo in combination with
stereotactic body radiotherapy (“SBRT”), and other of Regeneron’s
Product Candidates discussed or referenced in this press release;
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 in
combination with REGN5668 for the treatment of recurrent ovarian
cancer and Libtayo in combination with SBRT for the treatment of
early-stage hepatocellular carcinoma; 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 and
Regeneron’s Product Candidates (such as Libtayo in combination with
REGN5668 and Libtayo in combination with SBRT); 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 and Regeneron’s Product
Candidates (such as Libtayo in combination with REGN5668 and
Libtayo in combination with SBRT) 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 September 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
RelationsTaylor RamseyTel: +1
914-409-2381taylor.ramsey@regeneron.com |
Investor
RelationsVesna TosicTel: +1
914-847-5443vesna.tosic@regeneron.com |
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