Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced
positive new results from an ongoing Phase 1/2 trial evaluating its
first-in-class costimulatory bispecific antibody, REGN7075
(EGFRxCD28), in combination with Libtayo® (cemiplimab) in patients
with advanced solid tumors. Data from the dose-escalation portion
of the trial showed the investigational combination led to
anti-tumor responses in patients with microsatellite stable
colorectal cancer (MSS CRC). REGN7075 is one of the first
immunotherapies to demonstrate clinical activity in MSS CRC,
including in a patient with liver metastases. The results will be
shared during an oral session at the American Society of Clinical
Oncology (ASCO) 2024 Annual Meeting in Chicago.
“Microsatellite stable colorectal cancer has historically been
unresponsive to immunotherapy,” said Neil H. Segal, M.D., Ph.D.,
Medical Oncologist and Research Director in the Division of
Gastrointestinal Oncology at Memorial Sloan Kettering Cancer
Center, and a trial investigator. “The early results for this novel
investigational EGFRxCD28 costimulatory bispecific in combination
with Libtayo are encouraging, showing anti-tumor responses in a
highly difficult-to-treat cancer. This combination is one of the
first immunotherapy regimens to show clinical activity in
microsatellite stable colorectal cancer, and we are excited to
advance this trial in additional tumor types.”
In the dose-escalation portion of the trial, patients with
metastatic and locally advanced solid tumors – who had exhausted
standard treatment options, and most of whom also had liver
metastases – received combination therapy with REGN7075 and
Libtayo, following a REGN7075 monotherapy lead-in dose. Among 94
patients treated as of data cutoff, 65% (n=61) had MSS CRC, of
which 51 MSS CRC patients were treated at an active dose
level. Efficacy results among these 51 patients were as
follows:
- 6% (n=3) overall response rate (ORR) and 29% (n=15) disease
control rate (DCR). This included one complete response (CR), two
partial responses (PR), and 12 patients with stable disease. At
data cutoff, all responders were without liver metastases.
- Among the subset of 15 patients without liver metastases, there
was a 20% ORR (n=3) and 80% DCR (n=12).
- Among the subset of 36 patients with liver metastases, three
patients had stable disease as of data cutoff, and one patient
achieved a PR following data cutoff.
Safety was assessed in 84 patients across multiple solid tumor
types at a variety of doses of REGN7075. REGN7075 and Libtayo
showed an acceptable safety profile, and the maximum tolerated dose
was not reached. Treatment-emergent adverse events (TEAEs) of any
grade occurred in 98% of patients; Grade 3 and 4 TEAEs occurred in
35% of patients. Treatment-related adverse events (TRAEs) occurred
in 90% of patients, with 7% of cases reported as grade 3 or 4. The
majority of TRAEs were Grade 1 to 2 (83%), with the most common
being infusion-related reactions (58%) that were manageable with
premedication and dosing adjustments. TRAEs led to discontinuation
in 5% of patients, and three patients discontinued treatment due to
Grade 2 infusion-related reactions. As of data cutoff, there have
been no dose-limiting toxicities, no reports of cytokine release
syndrome, and no treatment-related deaths.
“Regeneron is focused on developing a unique investigational
portfolio of oncology medicines including checkpoint inhibitors,
CD3 bispecifics and CD28 costimulatory bispecifics. Over the past
several years, we have made progress in our programs across
checkpoint inhibitors and the CD3 class and are now showing
promising activity with two costimulatory bispecific antibodies,”
said Israel Lowy, M.D., Ph.D., Senior Vice President, Translational
and Clinical Oncology at Regeneron. “Our costimulatory bispecifics
were designed with the goal of turning cancer cells into antigen
presenting cells, thereby converting historically immunotherapy
unresponsive tumors from ‘cold’ to ‘hot’. These early data speak to
the potential of REGN7075 in combination with Libtayo and add to a
growing body of evidence supporting novel costimulatory bispecifics
that are in clinical trials for a range of solid tumors and blood
cancers.”
The combination of REGN7075 and Libtayo is currently under
clinical development, and its safety and efficacy have not been
fully evaluated by any regulatory authority. While the dose
escalation portion of the trial across multiple solid tumor types
including non-small cell lung cancer, colorectal cancer, head and
neck cancer and other tumor types is ongoing, expansion cohorts in
several tumor types have also been initiated.
About the Phase 1/2 TrialThe Phase 1/2,
first-in-human, open-label trial investigating REGN7075 in
combination with Libtayo is currently enrolling patients with
metastatic and locally advanced solid tumors who have exhausted
standard treatment options. The trial includes an ongoing Phase 1
dose-escalation portion and a Phase 2 dose-expansion period. In the
Phase 1 dose-escalation portion, patients first receive a weekly
lead-in dose of REGN7075 monotherapy for three weeks to assess its
safety and efficacy alone. This is followed by treatment with
combination therapy, with Libtayo dosed once every three weeks and
REGN7075 dosed either every week or every three weeks. The primary
endpoints are assessing safety and tolerability, while the
secondary endpoints are assessing efficacy, pharmacokinetics and
immunogenicity. Expansion cohorts in several tumor types have been
initiated. For more information, visit the Regeneron clinical
trials website, or contact
via clinicaltrials@regeneron.com or 844-734-6643.
About Regeneron in Cancer We 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. 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 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 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 baby
- 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
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 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
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 spend 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 Regeneron Regeneron (NASDAQ:
REGN) is a leading biotechnology company that
invents, develops and commercializes life-transforming
medicines for people with serious diseases. Founded and led by
physician-scientists, our unique ability to repeatedly and
consistently translate science into medicine has led to
numerous approved treatments and product candidates in development,
most 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, neurological diseases, hematologic conditions,
infectious diseases, and rare diseases.
Regeneron pushes the boundaries of scientific discovery
and accelerates drug development using our proprietary
technologies, such as VelociSuite®, which produces optimized fully
human antibodies and new classes of bispecific antibodies. We are
shaping the next frontier of medicine with data-powered insights
from the Regeneron Genetics Center® and pioneering genetic medicine
platforms, enabling us to identify innovative targets and
complementary approaches to potentially treat or cure diseases. For
more information, please visit www.Regeneron.com or follow
Regeneron on LinkedIn, Instagram, Facebook or X.
Dr. Segal has financial interests related to Regeneron
Pharmaceuticals.
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 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
REGN7075 in combination with Libtayo® (cemiplimab) 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, such as
REGN7075 in combination with Libtayo in patients with advanced
solid tumors and the other clinical programs discussed or
referenced in the press release; 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 REGN7075 in combination with Libtayo); 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 REGN7075 in combination with Libtayo) 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), other litigation and other proceedings and government
investigations relating to the Company and/or its operations
(including the pending civil proceedings initiated or joined by the
U.S. Department of Justice and the U.S. Attorney's Office for the
District of Massachusetts), 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, 2023 and its Form
10-Q for the quarterly period ended March 31, 2024. 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 SkottTel: +1
914-409-2381taylor.ramsey@regeneron.com |
Investor
RelationsVesna TosicTel: +1
914-847-5443vesna.tosic@regeneron.com |
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