TARRYTOWN, N.Y. and
CAMBRIDGE, Mass., Sept. 3, 2020 /PRNewswire/ -- Regeneron
Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced the
presentation of new, positive data for the PD-1 inhibitor
Libtayo® (cemiplimab) at the European Society for
Medical Oncology (ESMO) Virtual Congress 2020 from September 19-21. Among the accepted abstracts are
two late-breaking oral presentations on the investigational use of
Libtayo monotherapy in first-line advanced non-small cell lung
cancer (NSCLC) and locally advanced basal cell carcinoma (BCC)
previously treated with a hedgehog inhibitor. Additional
presentations will include patient-reported quality-of-life and
real-world patient data for Libtayo in advanced cutaneous squamous
cell carcinoma (CSCC).
"Libtayo monotherapy continues to demonstrate significant
results in pivotal trials across diverse cancers, and we are
excited to share these data at ESMO," said Israel Lowy, M.D., Ph.D., Senior Vice President,
Translational and Clinical Sciences, Oncology, at Regeneron. "These
trial outcomes highlight the potential of Libtayo to advance
treatment of non-small cell lung cancer and basal cell carcinoma,
and will form the basis for regulatory submissions in the U.S. and
European Union."
Late-breaking oral presentations include:
- EMPOWER-Lung 1: Phase 3 first-line cemiplimab monotherapy vs
platinum-doublet chemotherapy in advanced NSCLC with programmed
cell death ligand-1 (PD-L1) ≥50% (Abstract 1158, LBA52;
Ahmet Sezer, M.D.; Proffered Paper
Presentation)
- Primary analysis of Phase 2 results for cemiplimab in patients
with locally advanced BCC who progress on or are intolerant to
hedgehog inhibitors (HHIs) (Abstract 3933, LBA47; Alexander Stratigos, M.D.; Mini-oral
Presentation)
"The Libtayo clinical development program, as monotherapy or in
combination with either conventional or novel therapies, focuses on
the real-world challenges of patients confronting
difficult-to-treat or rare cancers," said Peter Adamson, M.D., Global Development Head,
Oncology and Pediatric Innovation at Sanofi. "This development
approach was evidenced by the initial approval of Libtayo for
patients with advanced cutaneous squamous cell carcinoma, and it
continues to guide our Libtayo clinical development program for
non-small cell lung cancer and basal cell carcinoma."
Additional Libtayo presentations include:
- Time to clinically meaningful changes in pain in patients with
advanced CSCC treated with cemiplimab in a Phase 2 clinical trial
(Abstract 3955; Poster 1087P; Michael
Migden, M.D.; Poster Presentation)
- Demographics, prior therapies and reasons for cemiplimab
treatment: prospective CemiplimAb-rwlc Survivorship and
Epidemiology (C.A.S.E.) study in patients with advanced CSCC
(Abstract 1996; Poster 1094P; Guilherme Rabinowits, M.D.; Poster
Presentation)
- EMPOWER-Lung 4: Phase 2, randomized, open-label high dose or
standard dose cemiplimab alone/plus ipilimumab in the second-line
treatment of advanced NSCLC (Abstract 4033; Poster 1269P;
Byoung Yong Shim, M.D.; Poster
Presentation)
Libtayo is being jointly developed by Regeneron and Sanofi under
a global collaboration agreement. Libtayo was invented using
Regeneron's 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 to
create REGN-COV2, a potentially preventative and therapeutic
medicine for COVID-19.
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 immunotherapy approved in the U.S., EU, 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 trials in
adjuvant and neoadjuvant CSCC in addition to the pivotal trial in
advanced BCC. Libtayo is also being investigated in pivotal trials
in NSCLC and cervical cancer, as well as in trials combining
Libtayo with either conventional or 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.
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. You can
have more than one problem 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 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 or persistent muscle pain, 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,
diarrhea, muscle or bone pain, and nausea. 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.
Please see accompanying 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.
About Sanofi
Sanofi is dedicated to supporting people through their health
challenges. We are a global biopharmaceutical company focused on
human health. We prevent illness with vaccines, provide innovative
treatments to fight pain and ease suffering. We stand by the few
who suffer from rare diseases and the millions with long-term
chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is
transforming scientific innovation into healthcare solutions around
the globe.
Sanofi, Empowering Life
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, and 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); 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, adjuvant and neoadjuvant cutaneous
squamous cell carcinoma, and cervical cancer (as well as in trials
combining Libtayo with either conventional or novel therapeutic
approaches for both solid tumors and blood cancers, as
applicable); 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; safety issues
resulting from the administration of Regeneron's Products (such as
Libtayo) and product candidates 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
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 product
candidates; the extent to which the results from the research and
development programs conducted by Regeneron and/or its
collaborators may be replicated in other studies and/or lead
to advancement of product candidates to clinical trials,
therapeutic applications, or regulatory approval; 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 EYLEA®
(aflibercept) Injection, 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 June
30, 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).
Sanofi Forward-Looking Statements
This press release contains forward-looking statements as
defined in the Private Securities Litigation Reform Act of 1995, as
amended. Forward-looking statements are statements that are not
historical facts. These statements include projections and
estimates regarding the marketing and other potential of the
product, or regarding potential future revenues from the product.
Forward-looking statements are generally identified by the words
"expects", "anticipates", "believes", "intends", "estimates",
"plans" and similar expressions. Although Sanofi's management
believes that the expectations reflected in such forward-looking
statements are reasonable, investors are cautioned that
forward-looking information and statements are subject to various
risks and uncertainties, many of which are difficult to predict and
generally beyond the control of Sanofi, that could cause actual
results and developments to differ materially from those expressed
in, or implied or projected by, the forward-looking information and
statements. These risks and uncertainties include among other
things, unexpected regulatory actions or delays, or government
regulation generally, that could affect the availability or
commercial potential of the product, the fact that product may not
be commercially successful, the uncertainties inherent in research
and development, including future clinical data and analysis of
existing clinical data relating to the product, including post
marketing, unexpected safety, quality or manufacturing issues,
competition in general, risks associated with intellectual property
and any related future litigation and the ultimate outcome of such
litigation, and volatile economic and market conditions, and the
impact that COVID-19 will have on us, our customers, suppliers,
vendors, and other business partners, and the financial condition
of any one of them, as well as on our employees and on the global
economy as a whole. Any material effect of COVID-19 on any of
the foregoing could also adversely impact us. This situation is
changing rapidly and additional impacts may arise of which we are
not currently aware and may exacerbate other previously identified
risks. The risks and uncertainties also include the uncertainties
discussed or identified in the public filings with the SEC and the
AMF made by Sanofi, including those listed under "Risk Factors" and
"Cautionary Statement Regarding Forward-Looking Statements" in
Sanofi's annual report on Form 20-F for the year ended December 31, 2019. Other than as required by
applicable law, Sanofi does not undertake any obligation to update
or revise any forward-looking information or statements.
Regeneron
Contacts:
|
Sanofi
Contacts:
|
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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
|
Media
Relations
Sally Bain
Tel.: +1 (781)
264-1091
sally.bain@sanofi.com
Investor Relations
Paris
Eva
Schaefer-Jansen
Arnaud
Delepine
Yvonne
Naughton
Investor Relations
North America
Felix
Lauscher
Fara
Berkowitz
Suzanne
Greco
IR main
line:
Tel.: +33 (0)1 53 77
45 45
ir@sanofi.com
|
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SOURCE Regeneron Pharmaceuticals, Inc.