Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the
first presentation of key secondary endpoints for an
investigational regimen of PD-1 inhibitor Libtayo® (cemiplimab) as
a neoadjuvant monotherapy in stage II to IV resectable cutaneous
squamous cell carcinoma (CSCC). The results from an international
Phase 2 trial were presented in an oral session at the European
Society for Medical Oncology (ESMO) Congress 2023 and concurrently
published in The Lancet Oncology.
“Advanced, resectable cutaneous squamous cell carcinoma can lead
to reduced patient function and quality of life following the
cumulative effects of treatment, typically surgery and radiation.
Additionally, risk of recurrence and death is a consideration for
these patients,” said Neil D. Gross, M.D., F.A.C.S., Director of
Clinical Research, Department of Head and Neck Surgery at the
University of Texas MD Anderson Cancer Center and principal
investigator of the trial. “Results from both the
single-institution pilot trial and the multi-center Phase 2 trial
found neoadjuvant cemiplimab was highly active in patients with
resectable cutaneous squamous cell carcinoma. These robust
responses were durable, translating into event-free survival for
the vast majority of patients at one and two years.”
The multicenter, single-arm Phase 2 trial included two parts. In
Part 1, patients (n=79) received Libtayo 350 mg every three weeks
for up to four doses, followed by curative-intent surgery. Per the
primary analysis presented at ESMO 2022 and published in the New
England Journal of Medicine, there was a 63.3% (n=50) combined
pathologic response rate. This included a 50.6% (n=40) pathologic
complete response rate (pCR; 0% residual viable tumor) and a 12.7%
(n=10) major pathologic response rate (MPR; >0% and ≤10%
residual tumor cells). In Part 2, the post-surgical part of the
trial, patients who completed curative intent surgery (n=70),
received an investigator’s choice of Libtayo, radiation or
observation.
The presentation at this year’s ESMO shared secondary survival
endpoints among all 79 patients in the trial, continuing to
demonstrate encouraging outcomes at one-year (median duration of
follow-up: 19 months; range: 1-30 months), including:
- 89% event-free survival rate (95% confidence
interval [CI]: 79%-94%) at one year, per Kaplan-Meier estimates,
with the median not reached
- No disease recurrence among patients who
achieved a pCR (n=40). Among those achieving an MPR, 9 of 10
remained disease-free at one year
- 92% overall survival rate (95% CI: 83%-96%) at
one year, per Kaplan-Meier estimates, with the median not
reached
Among all patients, adverse events (AE) of any grade occurred in
89% of patients, with 19% being ≥grade 3, and one death due to
worsening congestive heart failure considered possibly related to
treatment. Among those who received adjuvant Libtayo in Part 2 of
the trial (n=16), there were two grade 3 serious AEs including
worsening cardiomyopathy and hypophysitis (n=1 each) and no deaths
considered related to treatment.
“The primary analysis of this Phase 2 trial demonstrated greater
than 60% response rates, and it is encouraging that Libtayo may
have utility in this earlier stage of cutaneous squamous cell
carcinoma,” said Israel Lowy, M.D., Ph.D., Senior Vice President,
Translational and Clinical Sciences, Oncology at Regeneron. “These
new data add to the growing body of evidence for Libtayo in this
investigational setting where high unmet patient need remains.”
A separate ongoing global Phase 3 trial is investigating Libtayo
in the adjuvant CSCC setting for patients at heightened risk (i.e.,
due to involvement of multiple lymph nodes, extension of cancer
through the lymph node capsule, perineural invasion) for recurrence
after surgery and radiotherapy.
The potential use of Libtayo described above is investigational,
and its safety and efficacy has not been evaluated by any
regulatory authority for this 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 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); 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 in stage II to IV
resectable cutaneous squamous cell carcinoma (“neoadjuvant CSCC”)
as discussed in this press release as well as Libtayo as a
monotherapy or in combination with either conventional or novel
therapeutic approaches for other solid tumors and blood cancers;
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 for the treatment of neoadjuvant CSCC) and Regeneron’s
Product Candidates; 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 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
RelationsTaylor RamseyTel: +1
914-409-2381taylor.ramsey@regeneron.com |
Investor
RelationsVesna TosicTel: +1
914-847-5443vesna.tosic@regeneron.com |
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