TARRYTOWN, N.Y. and
PARIS, May
5, 2020 /PRNewswire/ --
Objective responses seen in approximately 29% of patients
with locally advanced basal cell carcinoma (BCC)
In a preliminary analysis, objective responses seen in 21% of
patients with metastatic BCC
Approximately 85% of patients who responded to Libtayo
maintained their response for at least one year
Regeneron and Sanofi plan regulatory submissions in
2020
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and
Sanofi today announced topline data from a pivotal, single-arm,
open-label trial for the PD-1 inhibitor Libtayo in patients with
advanced basal cell carcinoma (BCC) who had progressed on or were
intolerant to prior hedgehog pathway inhibitor (HHI) therapy.
Libtayo demonstrated clinically meaningful and durable responses in
this group of patients for whom there are currently no approved
treatments. Regeneron and Sanofi plan regulatory submissions in
2020.
BCC is a skin cancer and is the most common cancer worldwide,
with approximately two million new cases diagnosed every year in
the U.S. alone. While the vast majority of BCCs are caught early
and easily cured with surgery and radiation, a small proportion of
tumors can become advanced and penetrate deeper into surrounding
tissues (locally advanced), which is more difficult to treat.
Approximately 20,000 U.S. patients have advanced BCC, and it is
estimated that about 3,000 die each year. BCC marks the second
non-melanoma skin cancer for which Libtayo has demonstrated
first-in-class data and follows its initial U.S. approval in
advanced cutaneous squamous cell carcinoma (CSCC) in 2018.
In the trial, the objective response rate (ORR) for patients
(n=84) with locally advanced disease was 29% (95% CI: 19%-40%),
with an estimated duration of response (DOR) exceeding one year in
85% of responders. The durable disease control rate (DCR – response
or stable disease lasting at least six months) was 60% (95% CI:
48%-70%). In a preliminary analysis of patients (n=28) with
metastatic disease, the ORR was 21% (95% CI: 8%-41%), with an
estimated DOR exceeding one year in 83% of responders. The durable
DCR was 46% (95% CI 28%-66%). All data were assessed by an
independent central review. Data are expected to continue to evolve
with further follow-up across both patient groups.
"We are very encouraged by these clinically-meaningful response
rates and durations of response, which are particularly impressive
given this is a second-line setting where there are no approved
therapies," Israel Lowy, M.D.,
Ph.D., Senior Vice President, Translational and Clinical Sciences,
Oncology at Regeneron. "These data in advanced BCC provide the
third instance where Libtayo monotherapy has demonstrated robust
and clinically meaningful outcomes in advanced cancer, and follows
last week's announcement in advanced non-small cell lung cancer
where the pivotal trial was stopped early for positive overall
survival."
There were no new safety signals in this trial. Among the 132
patients assessed for safety (84 locally advanced and 48
metastatic), 95% experienced an adverse event (AE), 32% had a
serious AE and 13% discontinued due to an AE. There were 10 deaths
in the locally advanced group and nine deaths in the metastatic
group; none of the deaths were considered treatment-related.
Regeneron and Sanofi will present additional trial findings at an
upcoming medical meeting.
"While PD-1 inhibitors have transformed the outlook for many
patients with melanoma, progress for patients with non-melanoma
skin cancers has not been as rapid," said Peter C. Adamson, M.D., Global Head of Oncology
Development at Sanofi. "We are continuing to address this unmet
need by first bringing Libtayo to patients with advanced cutaneous
squamous cell carcinoma, and now, with this second trial, as a
potential therapy for patients with advanced basal cell carcinoma.
These important new results further demonstrate Libtayo's potential
in patients with difficult-to-treat, non-melanoma skin
cancers."
In this ongoing, global Phase 2 trial, patients received Libtayo
350 mg intravenously every three weeks for up to 93 weeks or until
disease progression, unacceptable toxicity, withdrawal of consent
or confirmed complete response. ORR is the primary endpoint and key
secondary endpoints include overall survival, progression-free
survival, duration of response, safety and quality of life.
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 BCC is investigational and
the safety and efficacy have not been evaluated by any regulatory
authority.
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., 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 trials in
adjuvant and neoadjuvant CSCC. Libtayo is also being investigated
in potentially registrational Phase 3 trials in non-small lung
cancer 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.
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) in patients with
advanced basal cell carcinoma ("BCC"), 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 applicable) for the treatment of
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 BCC, NSCLC, 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 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:
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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.: +1 617 834 6026
sally.bain@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.