TARRYTOWN, N.Y. and
PARIS, April 27, 2020 /PRNewswire/ --
Libtayo decreased the risk of death by 32.4% compared to
chemotherapy
Regeneron and Sanofi plan regulatory
submissions in 2020
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and
Sanofi today announced the primary endpoint of overall survival
(OS) was met in a Phase 3 trial comparing the PD-1 inhibitor
Libtayo® (cemiplimab) to platinum-doublet chemotherapy
in patients with first-line locally advanced or metastatic
non-small cell lung cancer (NSCLC) that tested positive for PD-L1
in ≥50% of tumor cells. Based on a recommendation by the
Independent Data Monitoring Committee to stop the trial early, the
trial will be modified to allow all patients to receive Libtayo for
this investigational use. The data will form the basis of
regulatory submissions in the U.S. and European Union (EU) in
2020.
"While demonstrating a survival benefit in first-line NSCLC has
been challenging for immunotherapies, the one FDA-approved
anti-PD-1 monotherapy has changed the therapeutic paradigm," said
George D. Yancopoulos, M.D., Ph.D.,
Co-Founder, President and Chief Scientific Officer of Regeneron.
"We are pleased with the results of this trial that demonstrate the
survival benefit of Libtayo in these patients and hope it may
become a potential alternative for physicians and patients."
A protocol-specified interim analysis conducted by the
Independent Data Monitoring Committee demonstrated that patients
treated with Libtayo monotherapy had a significant increase in OS.
Libtayo decreased the risk of death by 32.4% (HR=0.676;
CI:0.525-0.870, p=0.002), compared to platinum-doublet
chemotherapy, despite a third of patients entering the trial within
the past six months and all chemotherapy patients being able to
crossover to Libtayo if their disease progressed. No new Libtayo
safety signal was identified. Detailed trial data will be presented
at a future medical meeting.
"This is the largest clinical trial evaluating a PD-1 inhibitor
as a first-line monotherapy in patients with advanced non-small
cell lung cancer with high PD-L1 expression. These positive results
are extremely encouraging, and we look forward to advancing a
potential new treatment option for these patients," said
John Reed, M.D., Ph.D., Global Head
of Research and Development at Sanofi. "We are grateful to all of
the investigators and patients who participated in the global
trial."
Lung cancer is the leading cause of cancer death worldwide. In
2020, more than 2.2 million new cases are expected to be diagnosed
globally, with 228,800 new cases in the U.S. alone. Approximately
85% of all lung cancers are NSCLC, with an estimated 25% to 30% of
cases expected to test positive for PD-L1 in ≥50% of tumor cells.
While immunotherapies have transformed advanced NSCLC treatment in
recent years, there remains an unmet need to optimize the
identification and treatment of patients with high PD-L1
expression.
Libtayo is being jointly developed and commercialized by
Regeneron and Sanofi under a global collaboration agreement.
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.
The use of Libtayo to treat advanced NSCLC is investigational
and has not been fully evaluated by any regulatory authority.
About the Phase 3 Trial
The open-label, randomized,
multi-center Phase 3 trial investigated the first-line treatment of
Libtayo monotherapy compared to platinum-doublet chemotherapy
in squamous or non-squamous advanced NSCLC that tested positive for
PD-L1 in ≥50% of tumor cells. The trial included 712 patients (of
whom 710 were included in the interim analysis) with locally
advanced NSCLC (Stage IIIB/C), who were not candidates for
surgical resection or definitive chemoradiation or had progressed
after treatment with definitive chemoradiation, or previously
untreated metastatic NSCLC (Stage IV). The trial offers the largest
data set from a pivotal trial currently available for this patient
population.
Patients were randomized 1:1 to receive either Libtayo 350 mg
administered intravenously every three weeks for up to 108 weeks,
or an investigator-selected, platinum-doublet chemotherapy
regimen for four to six cycles (with or without maintenance
pemetrexed chemotherapy). The primary endpoints are OS and
progression-free survival (PFS), and secondary endpoints include
overall response rate, duration of response and quality of
life.
The trial was designed to reflect current and emerging treatment
paradigms. Inclusion criteria allowed patients with NSCLC that had:
controlled hepatitis B, hepatitis C or HIV; pre-treated and stable
brain metastases; and/or locally advanced disease that had
progressed on definitive chemoradiation. Patients whose disease
progressed in the trial were able to change their therapy: those in
the chemotherapy arm were allowed to crossover into the Libtayo
arm, while those in the Libtayo arm were allowed to combine Libtayo
treatment with four to six cycles of chemotherapy.
A separate Phase 3 trial evaluating a first-line combination of
Libtayo and chemotherapy in patients with advanced NSCLC
irrespective of PD-L1 expression is also underway and expected to
be fully enrolled in 2020.
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 approved in the U.S., EU, and other countries for
adults with metastatic cutaneous squamous cell carcinoma (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 a potentially registrational Phase 3
trial in 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.
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.
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, suppliers, and other
third parties on which Regeneron relies, Regeneron's and its
collaborators' ability to continue to conduct research and clinical
programs (including those discussed in this press release),
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) as a
monotherapy and combination therapy in patients with first-line
locally advanced or metastatic non-small cell lung cancer ("NSCLC")
and as a monotherapy or in combination with conventional treatments
or other investigational agents (as applibcable) for the treatment
of basal cell carcinoma, adjuvant and neoadjuvant cutaneous
squamous cell carcinomas, cervical cancer, blood cancers, and other
potential indications; 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 lead to
therapeutic applications; 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 without limitation any possible regulatory approval of
Libtayo (as a monotherapy or in combination with conventional
treatments or other investigational agents, as applicable) for the
treatment of NSCLC, basal cell carcinoma, adjuvant and neoadjuvant
cutaneous squamous cell carcinomas, cervical cancer, blood cancers,
and other potential indications; unforeseen safety issues resulting
from the administration of Regeneron's Products and product
candidates in patients, including serious complications or side
effects in connection with the use of Regeneron's Products and
product candidates (such as Libtayo) in clinical trials (including
those referenced in this press release); 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
(such as Libtayo), research and clinical programs, and business,
including those relating to patient privacy; 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 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 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. 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 and their
underlying assumptions, statements regarding plans, objectives,
intentions and expectations with respect to future financial
results, events, operations, services, product development and
potential, and statements regarding future performance.
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, the uncertainties inherent in research and development,
future clinical data and analysis, including post marketing,
decisions by regulatory authorities, such as the FDA or the EMA,
regarding whether and when to approve any drug, device or
biological application that may be filed for any such product
candidates as well as their decisions regarding labelling and other
matters that could affect the availability or commercial potential
of such product candidates, the fact that product candidates if
approved may not be commercially successful, the future approval
and commercial success of therapeutic alternatives, Sanofi's
ability to benefit from external growth opportunities, to complete
related transactions and/or obtain regulatory clearances, risks
associated with intellectual property and any related pending or
future litigation and the ultimate outcome of such
litigation, trends in exchange rates and prevailing interest
rates, volatile economic and market conditions, cost
containment initiatives and subsequent changes thereto, 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
Ashleigh
Koss
Tel: +1 (908)
981-8745
ashleigh.koss@sanofi.com
Investor
Relations
Felix
Lauscher
Tel.: +33 (0)1 53 77
45 45
ir@sanofi.com
|
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SOURCE Regeneron Pharmaceuticals, Inc.