TARRYTOWN, N.Y., Nov. 5, 2019 /PRNewswire/ -- Regeneron
Pharmaceuticals, Inc. (NASDAQ: REGN) today provided an
update on the ongoing Phase 3 development program evaluating
Libtayo® (cemiplimab), a PD-1 inhibitor, as monotherapy
and combination therapy in first-line patients with advanced
non-small cell lung cancer (NSCLC). Regeneron is currently
recruiting patients in two Phase 3 trials in first-line NSCLC.
The first trial, an open-label randomized trial that compares
Libtayo monotherapy to standard-of-care platinum-based chemotherapy
in patients with high PD-L1 expression (tumor proportion score
[TPS] >50%):
- The trial has enrolled 90% of the 700 planned patients
and is expected to be fully enrolled by
year's end.
- The independent data monitoring committee recently conducted an
interim analysis for overall survival (OS) based on approximately
34% of anticipated events and recommended the trial should continue
as planned. The next event-driven interim analysis for OS is
anticipated in 2020.
- In the first 361 randomized patients (minimum 6 months of
follow-up), the confirmed objective response rate (ORR), as
determined by investigators, is currently 42% for Libtayo patients
and 22% for patients treated with chemotherapy.
The second trial, which consists of two parts, evaluates Libtayo
in combination with platinum-based chemotherapy:
- Part 1 is fully enrolled (n=323), and evaluates patients with
PD-L1 expression of <50% in three treatment groups:
chemotherapy, chemotherapy with Libtayo, and chemotherapy in
combination with Libtayo and ipilimumab.
- Part 2, a randomized, double-blind, placebo-controlled Phase 3
trial (n=450), has enrolled approximately 20% of patients, and is
expected to complete enrollment in the second half of 2020. The
trial evaluates patients with all PD-L1 expression levels in two
treatment groups: chemotherapy alone or chemotherapy in combination
with Libtayo.
Libtayo is being jointly developed by Regeneron and Sanofi under
a global collaboration agreement. Libtayo is a PD-1 inhibitor that
was invented by Regeneron using the company's proprietary
VelocImmune® technology, which uses a
genetically-humanized mouse to produce optimized fully-human
antibodies.
About the Phase 3 Libtayo NSCLC Trials
The primary
endpoints of the randomized, open-label Phase 3 monotherapy trial
are OS and progression-free survival (PFS). Patients receive
either Libtayo 350 mg every 3 weeks or investigator's choice of a
standard-of-care platinum-based doublet chemotherapy regimen (with
or without maintenance therapy). Patients in the trial have stage
IIIB, IIIC or stage IV squamous or non-squamous NSCLC, are not
candidates for definitive chemotherapy and radiation, have not
received prior systemic treatment for their advanced disease, and
have high PD-L1 expression (TPS ³50%). As part of a separate
internal research effort assessing the effect of baseline patient
variables, an unintended aggregation of open-label ORR data by
treatment group occurred for the first 361 enrolled patients. In
NSCLC, regulatory authorities do not consider ORR a validated
surrogate endpoint.
In the Phase 3 combination trial, the Part 1 primary endpoint is
ORR and the Part 2 primary endpoints are OS and PFS. Patients in
the Libtayo treatment groups receive 350 mg every 3 weeks. Trial
patients have either stage IIIB or IIIC squamous or non-squamous
NSCLC and are not candidates for treatment with definitive
concurrent chemoradiation, or have stage IV disease and have not
received prior systemic treatment for recurrent or metastatic
NSCLC.
About Libtayo
Libtayo is a fully-human monoclonal
antibody targeting the immune checkpoint receptor PD-1 (programmed
cell death protein-1). It is approved in the U.S., European
Union, Canada and Brazil for adult patients 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 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.
In addition to NSCLC, Libtayo is also being investigated in
potential registrational trials in basal cell carcinoma and
cervical cancer, along with additional trials in squamous cell
carcinoma of the head and neck, melanoma, colorectal cancer,
prostate cancer, multiple myeloma, Hodgkin lymphoma and non-Hodgkin
lymphoma. These trials are designed to investigate Libtayo as
monotherapy; in combination with conventional treatments like
chemotherapy; or in combination with other investigational agents,
including vaccines, oncolytic viruses and bispecific antibodies,
among others. 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 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.
Please see accompanying full Prescribing Information,
including Medication Guide.
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.
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 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, neuromuscular
diseases, infectious diseases and rare diseases.
Regeneron is accelerating and improving the traditional drug
development process through our proprietary
VelociSuite® technologies, such as
VelocImmune® which produces optimized fully-human
antibodies, and 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.
Forward-Looking Statements and Use of Digital
Media
This press release includes forward-looking
statements that involve risks and uncertainties relating to future
events and the future performance of Regeneron Pharmaceuticals,
Inc. ("Regeneron" or the "Company"), and actual events or results
may differ materially from these forward-looking statements. Words
such as "anticipate," "expect," "intend," "plan," "believe,"
"seek," "estimate," variations of such words, and similar
expressions are intended to identify such forward-looking
statements, although not all forward-looking statements contain
these identifying words. These statements concern, and these risks
and uncertainties include, among others, the nature, timing, and
possible success and therapeutic applications of Regeneron's
products, product candidates, and research and clinical programs
now underway or planned, including without limitation
Libtayo® (cemiplimab) as a monotherapy and
combination therapy in first-line patients with advanced non-small
cell lung cancer ("NSCLC") and as a monotherapy or in
combination with conventional treatments or other investigational
agents for the treatment of basal cell carcinoma, cervical cancer,
squamous cell carcinoma of the head and neck, melanoma, colorectal
cancer, prostate cancer, multiple myeloma, Hodgkin lymphoma,
non-Hodgkin lymphoma, and other potential indications; the
likelihood and timing of achieving any of Regeneron's anticipated
clinical development milestones; unforeseen safety issues resulting
from the administration of products and product candidates in
patients, including serious complications or side effects in
connection with the use of Regeneron's product candidates (such as
Libtayo) in clinical trials (including the clinical trials
referenced in this press release); the likelihood and timing of
possible regulatory approval and commercial launch of Regeneron's
late-stage product candidates and new indications for marketed
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,
cervical cancer, squamous cell carcinoma of the head and neck,
melanoma, colorectal cancer, prostate cancer, multiple myeloma,
Hodgkin lymphoma, non-Hodgkin lymphoma, and other potential
indications; the extent to which the results from the research and
development programs conducted by Regeneron or its collaborators
may be replicated in other studies and lead to therapeutic
applications; ongoing regulatory obligations and oversight
impacting Regeneron's marketed products (such as Libtayo), research
and clinical programs, and business, including those relating to
patient privacy; 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; competing drugs and product
candidates that may be superior to Regeneron's products and product
candidates; uncertainty of market acceptance and commercial success
of 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; the availability and extent of reimbursement of
the Company'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; 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), the
ultimate outcome of any such proceedings, 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 fiscal year ended December
31, 2018 and its Form 10-Q for the quarterly period ended
September 30, 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, 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).
Contacts:
Media Relations
Sarah Cornhill
Tel: +1 (917) 297-1522
Sarah.Cornhill@regeneron.com
Investor Relations
Justin
Holko
Tel: +1 (914) 847-7786
Justin.Holko@regeneron.com
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SOURCE Regeneron Pharmaceuticals, Inc.