TARRYTOWN, N.Y. and
PARIS, May
29, 2020 /PRNewswire/ --
Across all groups combined, complete responses (CR) are now
16%; in the metastatic group with the longest follow-up CRs are
20%, nearly tripling with two additional years of follow-up
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi
today announced new, longer-term data for PD-1 inhibitor
Libtayo® (cemiplimab-rwlc) from a pivotal Phase 2 trial
in advanced cutaneous squamous cell carcinoma (CSCC), the deadliest
non-melanoma skin cancer. These results demonstrate both longer
durability and higher complete response (CR) rates than previously
reported. Furthermore, the data make up part of the largest and
most mature prospective clinical dataset in patients with
metastatic CSCC (mCSCC) or locally advanced CSCC (laCSCC) who are
not candidates for curative surgery or radiation. The data were
presented during the virtual 2020 American Society of Clinical
Oncology (ASCO) Annual Meeting.
"The three-year follow-up data demonstrate significant long-term
outcomes with Libtayo, which is now standard-of-care for patients
with advanced CSCC in many countries," said Dr. Danny Rischin, Director, Department of Medical
Oncology at Peter MacCallum Cancer Centre, Victoria, Australia. "The Libtayo data on
duration of response and overall survival provide new insights into
the longer-term treatment of advanced CSCC, with the median still
not reached for either measure. Remarkably, it is exciting to see
the number of complete responses increase with longer follow-up,
which reinforces the potential ongoing benefit of Libtayo treatment
in this aggressive skin cancer."
With up to three years of follow-up, results from the pivotal
Phase 2 trial showed 46% of patients (95% CI: 39%-53%) experienced
substantial tumor shrinkage following Libtayo treatment, with a
median time to response of 2 months (interquartile range: 2-4
months). Furthermore, more patients (16%) saw their tumors
disappear completely over time compared to previous analyses. Among
patients with metastatic disease who had the longest available
follow-up (Group 1 in table below), 20% of patients have now
achieved a CR, increasing from 7% in the 2017 primary analysis.
Among patients who achieved a CR in any group, median time to CR
was 11 months (interquartile range: 7-15 months). Median
overall survival and median duration of response have yet to be
reached for any treatment group.
Results by treatment group were as follows:
|
Group
1:
mCSCC
3 mg/kg
every
2
weeks
(n=59)
|
Group
2:
laCSCC
3 mg/kg
every
2 weeks
(n=78)
|
Group
3:
mCSCC
350 mg every
3
weeks
(n=56)
|
Total
(n=193)
|
Median duration of
follow-up (range)
|
19 months
(1–36)
|
16 months
(1–36)
|
17 months
(1–26)
|
16 months
(1–36)
|
Objective response
rate (95% confidence interval [CI])
|
51%
(38%–64%)
|
45%
(34%–57%)
|
43%
(30%–57%)
|
46%
(39%–53%)
|
CR (n)
|
20%
(12)
|
13%
(10)
|
16%
(9)
|
16%
(31)
|
Partial response
(n)
|
31%
(18)
|
32%
(25)
|
27%
(15)
|
30%
(58)
|
Median observed time
to response (interquartile range)*
|
2 months
(2–2)
|
2 months
(2–4)
|
2 months
(2–4)
|
2 months
(2–4)
|
Median observed time
to CR (interquartile range)
|
11 months
(7–18)
|
10 months
(7–13)
|
12 months
(8–17)
|
11 months
(7–15)
|
Median duration of
response (95% CI)*
|
Not
reached
(21, NE)
|
Not
reached
(18, NE)
|
Not
reached
(NE, NE)
|
Not
reached
(29, NE)
|
Median overall
survival
|
Not
reached
|
Not
reached
|
Not
reached
|
Not
reached
|
|
NE = not
evaluable
|
*Based on number
of patients with confirmed complete or partial response and
Kaplan-Meier estimation.
|
CR rates over time were as follows:
|
Group
1:
mCSCC
3 mg/kg
every
2
weeks
|
Group
2:**
laCSCC
3 mg/kg
every
2 weeks
|
Group
3:
mCSCC
350 mg every
3
weeks
|
Primary analysis, CR
% (n)
|
7%
(4)
|
13%
(10)
|
5%
(3)
|
Approximately 1 year
of follow-up, CR % (n)
|
17%
(10)
|
13%
(10)
|
16%
(9)
|
Approximately 2 years
of follow-up, CR % (n)
|
20%
(12)
|
NE
|
NE
|
|
**Among 23 laCSCC
patients who were included in the pre-specified Group 2 interim
analysis, there were no CRs.
|
No new safety signals were identified. The most common
treatment-emergent adverse events (AEs) were fatigue (35%),
diarrhea (28%) and nausea (24%). The most common grade 3 or higher
treatment-related AEs were pneumonitis (3%), autoimmune hepatitis
(2%), anemia, colitis and diarrhea (each 1%). No new AEs resulting
in death were reported compared to previous reports.
In addition to the updated efficacy and safety data, a separate
post-hoc analysis of health-related quality of life (HRQL) outcomes
from the Phase 2 trial was presented for the first time. A
significant majority (91%) of patients reported improved or stable
overall HRQL and 43% of patients experienced a clinically
meaningful reduction in pain by the end of the assessment period.
The analysis was based on patient responses to the European
Platform of Cancer Research cancer specific 30-item HRQL
questionnaire (QLQ-C30).
The open-label, single-arm, global, pivotal Phase 2 trial (Study
1540) enrolled 193 patients with laCSCC or mCSCC who were not
candidates for curative surgery or radiation. The initial primary
analysis of the trial, along with results from a Phase 1 trial
(Study 1423), supported the U.S. Food and Drug Administration (FDA)
approval of Libtayo in late 2018. Together, the trials
represent the largest and most mature prospective clinical dataset
in advanced CSCC.
Libtayo is being jointly developed 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.
About CSCC
CSCC is the second most common type of skin
cancer in the world, accounting for approximately 20% of all skin
cancers, and the number of newly diagnosed cases is expected to
rise substantially in many countries. Although CSCC has a good
prognosis when caught early, the cancer can prove especially
difficult to treat effectively when it is advanced, and patients
can experience reduced quality of life due to the impact of the
disease as it progresses. While estimates vary, sources suggest
that 7,000 patients in the U.S. die annually of advanced CSCC,
which is comparable to the number of deaths caused by melanoma.
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 mCSCC or laCSCC 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 pivotal
trial in advanced basal cell carcinoma and additional trials in
adjuvant and neoadjuvant CSCC. Libtayo is also being investigated
in pivotal Phase 3 trials in non-small cell 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 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.
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 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, 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-rwlc); 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 (such as Libtayo) and product candidates; 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 advanced basal cell carcinoma, adjuvant and
neoadjuvant cutaneous squamous cell carcinoma, non-small cell lung
cancer, and cervical cancer (as well as in combination with
novel therapeutic approaches for both solid tumors and blood
cancers, as applicable); unforeseen 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 (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 extent to which
the results from the research and development programs conducted by
Regeneron and/or its collaborators may lead to advancement
of product candidates to clinical trials or therapeutic
applications; 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 and its Form 10-Q
for the quarterly period ended March 31,
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 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:
|
|
|
Media
Relations
Daren Kwok
Tel: +1 (914)
847-1328
daren.kwok@regeneron.com
|
Media
Relations
Sally Bain
Tel.: +1 (781)
264-1097
sally.bain@sanofi.com
|
Investor
Relations
Vesna
Tosic
Tel: +1 (914)
847-5443
Vesna.Tosic@regeneron.com
|
Investor
Relations
Felix
Lauscher
Tel.: +33 (0)1 53 77
45 45
ir@sanofi.com
|
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