TARRYTOWN, N.Y., May 13, 2020 /PRNewswire/ --
Regeneron will host investor webcast on Monday, June 1 to discuss oncology program
strategy and progress
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN)
today announced the company will share updates from its diverse
clinical oncology portfolio at the 2020 American Society of
Clinical Oncology (ASCO) Annual Meeting from May 29-31 taking place virtually.
Among the accepted abstracts are new, longer-term data for PD-1
inhibitor Libtayo® (cemiplimab-rwlc) in advanced
cutaneous squamous cell carcinoma (CSCC). The data published today,
which will be updated during ASCO, add to the most mature dataset
for any therapy in advanced CSCC and show that median overall
survival and median duration of response have yet to be reached for
Libtayo-treated patients with no new safety signals observed.
Additional abstracts outline the clinical trial designs for
Regeneron's first costimulatory bispecific REGN5678 (PSMAxCD28) in
metastatic castration-resistant prostate cancer and the company's
first tumor-targeted bispecific REGN5093 (METxMET) in MET-altered
advanced non-small cell lung cancer (NSCLC).
"Regeneron is committed to advancing an oncology program to
potentially transform treatment paradigms across multiple solid
tumors and blood cancers where there are significant unmet needs,"
said Israel Lowy, M.D., Senior Vice
President, Translational and Clinical Sciences, Oncology at
Regeneron. "We've already made significant progress. Libtayo is the
standard of care for advanced cutaneous squamous cell carcinoma,
and we recently announced clinically meaningful outcomes from our
pivotal Libtayo trials in advanced non-small cell lung cancer and
advanced basal cell carcinoma. At ASCO, we will build on these
milestones with three-year data from Libtayo in advanced cutaneous
squamous cell carcinoma and updates from our expanding bispecific
antibody platform."
Investor Webcast Information
Regeneron will host a
conference call and simultaneous webcast to share updates on
Regeneron's oncology portfolio on Monday,
June 1 at 4:30 pm ET. To
access this call, dial (888) 660-6127 (U.S.) or (973) 890-8355
(International). A link to the webcast may be accessed from the
"Investors and Media" page of Regeneron's website at
www.regeneron.com. A replay of the conference call and webcast will
be archived on the Company's website and will be available for at
least 30 days.
Regeneron presentations and publications at ASCO
Libtayo (PD-1 inhibitor) & Skin Cancer (jointly
presented and published with Sanofi)
- Phase 2 study of cemiplimab in patients (pts) with advanced
cutaneous squamous cell carcinoma (CSCC): Longer follow-up
(Abstract 10018, Poster 367; Danny
Rischin, M.D.; Poster Discussion)
- Health-related quality of life (HRQL) in patients with advanced
cutaneous squamous cell carcinoma (CSCC) treated with cemiplimab:
Post hoc exploratory analysis of a Phase 2 clinical trial (Abstract
10033, Poster 382; Michael Migden,
M.D.; Poster)
- Assessing the value of cemiplimab for adults with advanced
cutaneous squamous cell carcinoma (CSCC): A cost-effectiveness
analysis (Abstract e19397; Eleanor
Paul; Online Publication)
- A Phase 3, randomized, double-blind study of adjuvant
cemiplimab versus placebo post-surgery and radiation therapy (RT)
in patients (pts) with high-risk cutaneous squamous cell carcinoma
(CSCC) (Abstract TPS10084, Poster 433; Danny Rischin, M.D.; Trial in Progress
Poster)
- Patterns of hedgehog inhibitor (HHI) treatment interruptions
and re-initiations among patients with basal cell carcinoma (BCC)
in real-world clinical practice (Abstract e19349; Jessica Jalbert, Ph.D.; Online Publication)
REGN5678 (PSMAxCD28 Costimulatory Bispecific)
- A Phase 1/2 study of REGN5678 (Anti-PSMAxCD28, a costimulatory
bispecific antibody) with cemiplimab (anti-PD-1) in patients with
metastatic castration-resistant prostate cancer (Abstract TPS5592,
Poster 173; Charles Drake, M.D.,
Ph.D.; Trial in Progress Poster)
REGN5093 (METxMET Tumor-targeted Bispecific)
- A Phase 1/2 study of REGN5093, a METxMET bispecific antibody,
in patients with MET-altered advanced non-small cell lung cancer
(NSCLC) (Abstract TPS9628, Poster 394; Tracey Rowlands, Ph.D.; Trial in Progress
Poster)
Diffuse Large B-Cell Lymphoma
- Real-world treatment patterns among patients with diffuse large
B-cell lymphoma (DLBCL) treated with CD19-directed chimeric antigen
receptor T-cell therapy (CAR T) (Abstract e19351; Jessica Jalbert, Ph.D.; Online Publication)
About the Regeneron Bispecific Antibody Platform
All
of Regeneron's bispecifics are designed to closely resemble natural
human antibodies and bind to two different targets. They are
derived from a next-generation version of Regeneron's proprietary
VelocImmune® technology and created using
the company's Veloci-Bi® platform. These
allow for the creation of bispecifics with no linkers or artificial
sequences. Additionally, Regeneron bispecifics are manufactured
using similar approaches used for human antibody medicines, with
similar pharmacokinetics.
There are six Regeneron investigational bispecific antibodies
currently in ongoing clinical trials for multiple blood cancers and
solid tumors. These bispecifics fall into three categories:
- CD3 bispecifics are designed to bridge T-cells and tumor
cells. At the tumor site, they activate T-cells via their CD3
receptors and promote T-cell killing of the cancer cells.
Investigational candidates include:
-
- CD20xCD3 (odronextamab) for B-cell non-Hodgkin lymphoma;
- Two distinct BCMAxCD3s (REGN5458 and REGN5459) for multiple
myeloma;
- MUC16xCD3 (REGN4018) for ovarian cancer.
- CD28 costimulatory bispecifics are also designed to
bridge T-cells and tumor cells. At the tumor site, they costimulate
T-cells via their CD28 receptors and may synergize with PD-1
inhibitors and/or CD3 bispecifics. Investigational candidates
include:
-
- PSMAxCD28 (REGN5678) in combination with Libtayo for prostate
cancer.
- Tumor-targeted bispecifics are designed
to target proteins only on the cancer cell. In this way, they
may affect various signaling pathways to hamper the cancer cells'
ability to survive and proliferate. Investigational candidates
include:
-
- METxMET (REGN5093) for NSCLC that is driven by MET mutations
and/or amplifications. REGN5093 targets two different parts of the
MET receptor on cancer cells to degrade the receptor and block its
ability to trigger cell proliferation.
The bispecifics mentioned in this release are currently under
clinical development, and their safety and efficacy have not been
evaluated by any regulatory authority. Libtayo in combination with
REGN5678 is currently under clinical development for metastatic
castration-resistant prostate cancer, and its safety and efficacy
have not been evaluated by any regulatory authority for this
use.
As part of a global collaboration agreement, Regeneron and
Sanofi are jointly developing the BCMAxCD3 and MUC16xCD3 bispecific
programs.
About Libtayo
Libtayo is a fully-human monoclonal
antibody targeting the immune checkpoint receptor PD-1 on T-cells.
By binding to PD-1, Libtayo has been shown to block cancer cells
from using the PD-1 pathway to suppress T-cell activation.
Libtayo is the first and only immunotherapy approved in the
U.S., European Union, and other countries for adults with
metastatic CSCC or locally advanced CSCC who are not candidates for
curative surgery or curative radiation. In the U.S., the generic
name for Libtayo in its approved indication 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.
The extensive clinical program for Libtayo is focused on
difficult-to-treat cancers. In skin cancer, this includes a
potentially registrational Phase 2 trial in basal cell carcinoma
and additional trials in adjuvant and neoadjuvant CSCC. Libtayo is
also being investigated in potentially registrational Phase 3
trials in NSCLC and cervical cancer, as well as in trials combining
Libtayo with novel therapeutic approaches for both solid tumors and
blood cancers. These potential uses are investigational, and their
safety and efficacy have not been evaluated by any regulatory
authority.
Libtayo was invented using Regeneron's proprietary
VelocImmune technology that utilizes a proprietary
genetically-engineered mouse platform endowed with a
genetically-humanized immune system to produce optimized
fully-human antibodies. VelocImmune technology has been used
to create multiple antibodies including Dupixent®
(dupilumab), Praluent® (alirocumab) and
Kevzara® (sarilumab), which are approved in multiple
countries around the world. Regeneron previously used these
technologies to rapidly develop a treatment for Ebola virus
infection, which is currently under review by the FDA, and is now
being used in efforts to create preventative and therapeutic
medicines for COVID-19.
IMPORTANT SAFETY INFORMATION AND INDICATION FOR U.S.
PATIENTS
What is Libtayo?
Libtayo is a prescription
medicine used to treat people with a type of skin cancer called
cutaneous squamous cell carcinoma (CSCC) that has spread or cannot
be cured by surgery or radiation.
It is not known if Libtayo is safe and effective in
children.
What is the most important information I should know about
Libtayo?
Libtayo is a medicine that may treat a type of skin
cancer 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.
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 symptoms of the following problems or these symptoms
get worse:
- Lung problems (pneumonitis). Signs and symptoms
of pneumonitis may include new or worsening cough, shortness of
breath, and chest pain.
- Intestinal problems (colitis) that can lead to tears or
holes in your intestine. Signs and symptoms of colitis
may include diarrhea (loose stools) or more frequent bowel
movements than usual; stools that are black, tarry, sticky or that
have blood or mucus; and severe stomach-area (abdomen) pain or
tenderness.
- Liver problems (hepatitis). Signs and symptoms of
hepatitis may include yellowing of your skin or the whites of your
eyes, severe nausea or vomiting, pain on the right side of your
stomach area (abdomen), drowsiness, dark urine (tea colored),
bleeding or bruising more easily than normal, and feeling less
hungry than usual.
- Hormone gland problems (especially the adrenal glands,
pituitary, thyroid and pancreas). Signs and symptoms that your
hormone glands are not working properly may include headaches that
will not go away or unusual headaches, rapid heartbeat, increased
sweating, extreme tiredness, weight gain or weight loss, dizziness
or fainting, feeling more hungry or thirsty than usual, hair loss,
feeling cold, constipation, deeper voice, very low blood pressure,
urinating more often than usual, nausea or vomiting, stomach-area
(abdomen) pain, and changes in mood or behavior, such as decreased
sex drive, irritability, or forgetfulness.
- Kidney problems, including nephritis and kidney failure.
Signs of these problems may include decrease in your amount of
urine, blood in your urine, swelling in your ankles, and loss of
appetite.
- Skin problems. Signs of these problems may include rash,
itching, skin blistering, and painful sores or ulcers in the mouth,
nose, throat, or genital area.
- Problems in other organs. Signs of these problems may
include headache, tiredness or weakness, sleepiness, changes in
heartbeat (such as beating fast, seeming to skip a beat, or a
pounding sensation), confusion, fever, muscle weakness, balance
problems, nausea, vomiting, stiff neck, memory problems, seizures
(encephalitis), swollen lymph nodes, rash or tender lumps on skin,
cough, shortness of breath, vision changes, or eye pain
(sarcoidosis), seeing or hearing things that are not there
(hallucinations), severe muscle weakness, low red blood cells
(anemia), bruises on the skin or bleeding, and changes in
eyesight.
- Rejection of a transplanted organ. Your doctor should
tell you what signs and symptoms you should report and monitor you,
depending on the type of organ transplant that you have had.
- Infusion (IV) reactions that can sometimes be severe
and life-threatening. Signs of these problems may include
chills or shaking, itching or rash, flushing, shortness of breath
or wheezing, dizziness, fever, feeling of passing out, back or neck
pain, and facial swelling.
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 delay or completely stop treatment 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 had an organ transplant;
- have lung or breathing problems;
- have liver or kidney problems;
- have diabetes;
- are pregnant or plan to become pregnant; Libtayo can harm your
unborn baby.
Females who are able to become pregnant:
-
- Your healthcare provider will give you a pregnancy test before
you start treatment.
- You should use an effective method of birth control during your
treatment and for at least 4 months after your last dose of
Libtayo. Talk with your healthcare provider about birth control
methods that you can use during this time.
- Tell your healthcare provider right away if you become pregnant
or think you may be pregnant during treatment with Libtayo.
- are breastfeeding or plan to breastfeed. It is not known if
Libtayo passes into your breast milk. Do not breastfeed during
treatment and for at least 4 months after the last dose of
Libtayo.
Tell your healthcare provider about all the medicines you
take, including prescription and
over-the-counter medicines, vitamins, and herbal supplements.
The most common side effects of Libtayo include tiredness, rash,
and diarrhea. These are not all the possible side effects of
Libtayo. Call your doctor for medical advice about side effects.
You may report side effects to FDA at 1-800-FDA-1088. You may also
report side effects to Regeneron Pharmaceuticals and Sanofi at
1-877-542-8296.
For more information, please see full Prescribing
Information, including Medication Guide.
About Regeneron Pharmaceuticals, Inc.
Regeneron
(NASDAQ: REGN) is a leading biotechnology company that invents
life-transforming medicines for people with serious diseases.
Founded and led for over 30 years by physician-scientists, our
unique ability to repeatedly and consistently translate science
into medicine has led to seven FDA-approved treatments and numerous
product candidates in development, all of which were homegrown in
our laboratories. Our medicines and pipeline are designed to help
patients with eye diseases, allergic and inflammatory diseases,
cancer, cardiovascular and metabolic diseases, pain, infectious
diseases and rare diseases.
Regeneron is accelerating and improving the traditional drug
development process through our
proprietary VelociSuite® technologies,
such as VelocImmune which uses unique
genetically-humanized mice to produce optimized fully-human
antibodies and bispecific antibodies, and through ambitious
research initiatives such as the Regeneron Genetics Center, which
is conducting one of the largest genetics sequencing efforts in the
world.
For additional information about the company, please visit
www.regeneron.com or follow @Regeneron on Twitter.
Regeneron 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 impact of SARS-CoV-2
(the virus that has caused the COVID-19 pandemic) on Regeneron's
business and its employees, collaborators, suppliers, and other
third parties on which Regeneron relies, Regeneron's and its
collaborators' ability to continue to conduct research and clinical
programs, Regeneron's ability to manage its supply chain, net
product sales of products marketed by Regeneron and/or its
collaborators (collectively, "Regeneron's Products"), and the
global economy; the nature, timing, and possible success and
therapeutic applications of Regeneron's Products and Regeneron's
product candidates and research and clinical programs now underway
or planned, including without
limitation Libtayo® (cemiplimab-rwlc),
REGN5678 (a PSMAxCD28 costimulatory bispecific antibody being
studied in combination with Libtayo), REGN5093 (a METxMET
bispecific antibody), and Regeneron's other investigational
bispecific antibodies discussed in this press release; uncertainty
of market acceptance and commercial success of Regeneron's Products
and product candidates and the impact of studies (whether conducted
by Regeneron or others and whether mandated or voluntary) on the
commercial success of Regeneron's Products and product candidates;
the likelihood, timing, and scope of possible regulatory approval
and commercial launch of Regeneron's product candidates and new
indications for Regeneron's Products, such as Libtayo for the
treatment of non-small cell lung cancer, basal cell carcinoma, and
cervical cancer (as well as in combination with novel
therapeutic approaches for both solid tumors and blood cancers, as
applicable); unforeseen safety issues resulting from the
administration of Regeneron's Products (such as Libtayo) and
product candidates (such as Regeneron's investigational bispecific
antibodies discussed in this press release) in patients, including
serious complications or side effects in connection with the use of
Regeneron's Products and 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
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
(such as Libtayo) 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 Regeneron's Products and product
candidates; the extent to which the results from the research and
development programs conducted by Regeneron and/or its
collaborators may lead to advancement of product candidates to
clinical trials or therapeutic applications; the ability of
Regeneron to manufacture and manage supply chains for multiple
products and product candidates; the ability of Regeneron's
collaborators, suppliers, or other third parties (as applicable) to
perform manufacturing, filling, finishing, packaging, labeling,
distribution, and other steps related to Regeneron's Products and
product candidates; 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 or collaboration agreement,
including Regeneron's agreements with Sanofi, Bayer, and Teva
Pharmaceutical Industries Ltd. (or their respective affiliated
companies, as applicable), to be cancelled or terminated without
any further product success; 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
Dupixent® (dupilumab) and
Praluent® (alirocumab)), 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, 2019 and its Form 10-Q
for the quarterly period ended March 31,
2020. 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 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
(http://newsroom.regeneron.com) and its Twitter feed
(http://twitter.com/regeneron).
Regeneron Contacts:
Media Relations
Daren Kwok
Tel: +1 (914) 847-1328
daren.kwok@regeneron.com
Investor Relations
Vesna Tosic
Tel: +1 (914) 847-5443
Vesna.Tosic@regeneron.com
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SOURCE Regeneron Pharmaceuticals, Inc.