TARRYTOWN, N.Y. and
PARIS, Sept. 21, 2020 /PRNewswire/ --
- In the overall trial population, Libtayo reduced risk of
death by 32% compared to chemotherapy
- In a prespecified analysis of patients with confirmed PD-L1
expression of ≥50%, Libtayo reduced risk of death by 43%
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi
today announced the presentation of positive pivotal trial data for
the investigational use of PD-1 inhibitor Libtayo®
(cemiplimab) in first-line locally advanced or metastatic non-small
cell lung cancer (NSCLC) at the European Society for Medical
Oncology (ESMO) Virtual Congress 2020. The trial compared Libtayo
monotherapy to platinum-doublet chemotherapy in patients whose
tumor cells expressed PD-L1, including those whose cancers had
confirmed PD-L1 expression of ≥50%. These results form the basis of
regulatory submissions, including in the U.S. and European
Union.
"In new analyses presented at ESMO, Libtayo reduced the risk of
death by 43% in patients whose cancer had confirmed PD-L1
expression of 50% or greater. This is notable given that nearly
three-quarters of patients crossed over from chemotherapy following
disease progression and 12% of patients had pretreated and stable
brain metastases," said Ahmet Sezer,
M.D., Associate Professor in the Department of Medical Oncology at
Başkent University in Adana, Turkey and a trial investigator.
"These results support Libtayo as a potential new option for
anti-PD-1 monotherapy in first-line advanced non-small cell lung
cancer."
The late-breaking ESMO presentation expands on topline results
shared in April. In the overall trial population (n=710), the
median follow-up was 13 months for both Libtayo (n=356; range:
<1-32 months) and chemotherapy (n=354; range: <1-32 months).
Among these patients, Libtayo demonstrated the following results
compared to chemotherapy:
- 32% reduced risk of death (hazard ratio [HR]=0.68; 95%
confidence interval [CI]: 0.53-0.87; p=0.0022).
- 22-month median overall survival (OS; 95% CI: 18 months
to not yet evaluable) compared to 14 months (95% CI: 12-19
months).
- 41% reduced risk of disease progression (HR=0.59; 95%
CI: 0.49-0.72; p<0.0001). The median progression-free survival
(PFS) was 6.2 months (95% CI: 4.5-8.3 months) compared to 5.6
months (95% CI: 4.5-6.1 months).
- 37% objective response rate (ORR; 95% CI: 32-42%; 3%
complete response [CR] and 33% partial response [PR] rate) compared
to 21% ORR (95% CI: 17-25%; 1% CR and 20% PR rate).
A prespecified analysis of data from patients whose cancers had
confirmed PD-L1 expression ≥50% (n=563) was also conducted. In this
group, the median follow-up was 11 months for both Libtayo (n=283;
range: <1-32 months) and chemotherapy (n=280; range: <1-30
months), and Libtayo demonstrated the following results compared to
chemotherapy:
- 43% reduced risk of death (HR=0.57; 95% CI: 0.42-0.77;
p=0.0002).
- Median OS was not yet reached (95% CI: 18 months to not
yet evaluable) compared to 14 months (95% CI: 11-18 months).
- 46% reduced risk of disease progression (HR=0.54; 95%
CI: 0.43-0.68; p<0.0001). The median PFS was 8 months (95% CI:
6-9 months) compared to 6 months (95% CI: 5-6 months).
- 39% ORR (95% CI: 34-45%; 2% CR and 37% PR rate) compared
to 20% ORR (95% CI: 16-26%; 1% CR and 19% PR rate).
The trial also found a direct correlation between tumor response
and PD-L1 expression level in Libtayo-treated patients. The ORR was
highest (46%; range: 36-56%) in tumors with ≥90% PD-L1 expression,
with target tumors shrinking by more than 40% after 6 months of
treatment on average (per last observation carried forward method).
This correlation with PD-L1 expression level was not observed with
chemotherapy.
In the overall trial population, the median duration of exposure
to Libtayo was 27 weeks (range: <1-115 weeks) and 18 weeks for
chemotherapy (range: <1-87 weeks). Overall adverse events (AEs)
occurred in 88% of Libtayo patients and 94% of chemotherapy
patients. Grade 3 or higher AEs occurred in 37% of Libtayo patients
and 49% of chemotherapy patients. Immune-mediated AEs were reported
in 17% of Libtayo patients and included hypothyroidism (6%),
hyperthyroidism (4%), pneumonitis (2%), hepatitis (2%), skin
adverse reaction (2%), arthritis, increased blood thyroid
stimulating hormone, thyroiditis, colitis, nephritis and peripheral
neuropathy (each 1%). Treatment discontinuation due to an AE
occurred in 6% of Libtayo patients and 4% of chemotherapy patients.
No new Libtayo safety signals were observed.
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 U.S. Food and
Drug Administration (FDA), and to create REGN-COV2, a potentially
preventative and therapeutic medicine for COVID-19.
Libtayo is being jointly developed by Regeneron and Sanofi under
a global collaboration agreement. 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 but not ALK, EGFR or ROS1. PD-L1
expression was confirmed using the PD-L1 IHC 22C3 pharmDx kit. The
trial included 712 patients with either 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).
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, standard-of-care, platinum-based, doublet
chemotherapy regimen for 4 to 6 cycles (with or without histology
relevant maintenance pemetrexed chemotherapy). The co-primary
endpoints are OS and 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 who had:
controlled hepatitis B, hepatitis C or HIV; pre-treated and stable
brain metastases; and/or locally advanced disease that had
progressed after 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 4 to 6 cycles of chemotherapy.
A prespecified interim analysis was performed after 50% of OS
events. Due to a highly significant improvement in OS at the
interim analysis, the trial was modified to allow all patients to
receive Libtayo based on an Independent Data Monitoring Committee
recommendation.
About Non-small Cell Lung Cancer
Lung cancer is the
leading cause of cancer death worldwide, with more than 2.2 million
new cases expected globally in 2020. Approximately 85% of all lung
cancers are NSCLC, and an estimated 25% to 30% of these cases are
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 and offer
additional treatment options.
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 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 FDA. Outside of the U.S., the generic name
for Libtayo in its approved indication is cemiplimab.
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 a 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:
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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
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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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