TARRYTOWN, N.Y. and
PARIS, May
21, 2018 /PRNewswire/ --
Results showed DUPIXENT demonstrated a significant
improvement in multiple asthma endpoints in two Phase 3 clinical
trials in a broad population of patients with uncontrolled asthma,
irrespective of minimum baseline eosinophil levels or other
biomarkers of Type 2 inflammation
Greater benefit observed in patients with higher levels of
markers of Type 2 inflammation, as evidenced by eosinophils or
exhaled nitric oxide levels
In steroid-sparing VENTURE trial, DUPIXENT-treated patients
substantially reduced use of oral corticosteroids, yet had fewer
exacerbations and improved lung function compared to
placebo
In both trials, DUPIXENT-treated patients showed significant
lung function improvement two weeks after first dose that was
sustained over 52 weeks
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi
announced that the New England Journal of Medicine (NEJM)
today published detailed results from two Phase 3 trials for the
investigational use of DUPIXENT® (dupilumab) in
moderate-to-severe asthma. The results showed that DUPIXENT
significantly reduced the risk of severe asthma attacks
(exacerbations), improved lung function and reduced dependence on
oral corticosteroids (OCS). The trials, known as QUEST and VENTURE,
are part of the pivotal clinical trial program that evaluated
DUPIXENT in uncontrolled asthma patients. These data were
simultaneously presented at the American Thoracic Society 2018
International Conference.
DUPIXENT demonstrated significant improvements in the key
primary and secondary endpoints across the overall populations in
both QUEST and VENTURE, with the largest benefit experienced in
patients with more severe Type 2 inflammatory asthma, as evidenced
by elevated blood eosinophils or exhaled nitric oxide levels. Type
2 asthma can also be characterized by other parameters, including
elevated Immunoglobulin E (IgE). DUPIXENT blocks the IL-4/IL-13
pathway, which is emerging as a central driver of Type 2 allergic
inflammation in asthma, as well as in a range of other allergic or
atopic diseases.
The investigational use of DUPIXENT as an add-on maintenance
treatment of adults and adolescents with uncontrolled
moderate-to-severe asthma is currently under regulatory review in
several countries, including the U.S., Japan and in the European Union (EU), and the
safety and efficacy for this use have not been evaluated by any
regulatory authority. In the U.S. the target action date is
October 20, 2018. DUPIXENT is
currently approved in a number of countries for the treatment of
adults with uncontrolled moderate-to-severe atopic dermatitis.
Clinical trials are also ongoing or planned across additional
important Type 2 inflammatory diseases including pediatric atopic
dermatitis and asthma, eosinophilic esophagitis, nasal polyps,
chronic obstructive pulmonary disease and food allergy.
About LIBERTY ASTHMA QUEST
The Phase 3 QUEST trial
showed that a broad population of adults and adolescents with
moderate-to-severe asthma (no minimum blood eosinophil level or
other biomarker requirement at baseline) benefited when DUPIXENT
was added to their standard therapies. DUPIXENT reduced severe
asthma attacks and improved lung function compared to placebo. Lung
function improvements were observed from the first measurement two
weeks after receiving the first dose of DUPIXENT, and improvements
were sustained throughout the 52-week trial. Patients also reported
improved asthma control and quality of life, as measured by the
5-item Asthma Control Questionnaire (ACQ-5) and Asthma Quality of
Life Questionnaire (AQLQ).
"About 20 percent of people with asthma continue to have
uncontrolled moderate-to-severe symptoms despite available
treatments," said Mario Castro,
M.D., Alan A. and Edith L. Wolff Professor of Pulmonary and
Critical Care Medicine at Washington
University School of Medicine in St. Louis. "The results published today in the
New England Journal of Medicine show evidence from a Phase 3
trial that a biologic may have the potential to help a broad
population of patients improve multiple key asthma treatment goals
when added to standard treatments. DUPIXENT was designed to inhibit
signaling from two important proteins (IL-4 and IL-13) involved in
Type 2 inflammation that contribute to uncontrolled symptoms in
many people with moderate-to-severe asthma."
The QUEST trial enrolled 1,902 patients worldwide, including
1,795 adults and 107 adolescents. The four study groups included
patients treated with 200 mg every other week (loading dose of 400
mg), 300 mg every other week (loading dose of 600 mg) and two
separate placebo groups. All patients continued on a medium- or
high-dose inhaled corticosteroid (ICS) and up to two additional
controller medicines throughout the study.
The NEJM publication provides data on key endpoints, including
data in the table below.
QUEST Data
Summary
|
Placebo-adjusted
reduction in annualized rate of severe asthma exacerbations over 52
weeks
|
|
200 mg Dupixent
(n=631) vs. Placebo (n=317)
|
300 mg Dupixent
(n=633) vs. Placebo (n=321)
|
Overall
population1
|
48
percent*
|
46
percent*
|
|
200 mg Dupixent
(n=264) vs. Placebo (n=148)
|
300 mg Dupixent
(n=277) vs. Placebo (n=142)
|
Patients with 300
eosinophils/ microliter or greater
|
66
percent±
|
67
percent*
|
Placebo-adjusted
absolute (percent) change in lung function (measured by
FEV1) from baseline to week
122
|
|
200 mg Dupixent
(n=611) vs. Placebo (n=307)
|
300 mg Dupixent
(n=610) vs. Placebo (n=313)
|
Overall
population1
|
140 mL*
(9
percent)
|
130 mL*
(9
percent)
|
|
200 mg Dupixent
(n=256) vs. Placebo (n=144)
|
300 mg Dupixent
(n=266) vs. Placebo (n=139)
|
Patients with 300
eosinophils/ microliter or greater
|
210mL±
(13
percent)
|
240mL*
(18
percent)
|
1 Co-primary endpoint, *p-value <0.001,
2 Number of patients with FEV1 measurement at
week 12, ±p-value nominal
For the 52-week treatment period, the overall rate of adverse
events was similar across treatment groups (81 percent in the
combined DUPIXENT-treated group and 83 percent in the combined
placebo-treated group). The rate of serious adverse events was 8
percent in the combined DUPIXENT-treated group and 8 percent in the
combined placebo-treated group. The most frequent adverse events
that occurred more frequently with DUPIXENT treatment vs. placebo
were injection site reactions (17 percent vs. 8 percent,
respectively), back pain (4 percent, both groups) and eosinophilia
(4 percent vs. 1 percent, respectively)..
About LIBERTY ASTHMA VENTURE
The Phase 3 VENTURE
trial also did not require minimum biomarker levels for enrollment.
The study showed that adults and adolescents with severe,
steroid-dependent asthma who were treated with DUPIXENT, when added
to standard therapies, could reduce their use of OCS medications
while improving asthma control compared to placebo at 24 weeks.
With DUPIXENT, OCS use decreased by 70 percent in the overall
population (vs. 42 percent for placebo), and 80 percent for
patients with baseline eosinophil levels 300 cells/mircroliter or
greater (vs. 43 percent for placebo). Despite reductions in OCS,
patients treated with DUPIXENT reduced the risk of severe asthma
attacks and improved lung function.
"Up to 45 percent of people with severe asthma rely on systemic
corticosteroids to control their symptoms, but potential long-term
side-effects should be taken into account according to global
asthma treatment guidelines," said Klaus
Rabe, M.D., Director of the Department of Pneumology at
LungenClinic Grosshansdorf and Professor of Medicine at Christian
Albrechts University, Kiel, Germany. "In the Phase 3 VENTURE trial, a
majority of patients treated with DUPIXENT and standard therapies
significantly reduced their use of oral steroids, and nearly half
of patients completely stopped using oral steroids, while improving
their asthma."
The 24-week VENTURE study enrolled 210 patients (103 in the
DUPIXENT group and 107 in the placebo group) with severe asthma who
regularly used maintenance OCS in the six months prior to
enrollment in the study. The two study groups were 300 mg DUPIXENT
every other week (loading dose of 600 mg) and placebo. All patients
continued on a high-dose ICS and up to two additional controller
medicines throughout the study. The prescribed OCS in the study was
prednisone or prednisolone.
The NEJM publication provides data on key endpoints, including
data in the tables below.
VENTURE Data
Summary
|
Reduction in OCS
dose at 24 weeks
|
|
300 mg Dupixent
(n=103)
|
Placebo
(n=107)
|
Overall
population1
|
70
percent*
|
42 percent
|
|
300 mg Dupixent
(n=48)
|
Placebo
(n=41)
|
Patients with 300
eosinophils/microliter or greater
|
80
percent*
|
43 percent
|
Proportion of
patients with 50 percent or greater reduction in OCS
|
Overall
population
|
80
percent*
|
50 percent
|
Proportion of
patients who reduced their OCS dose to less than 5 mg per
day
|
Overall
population
|
69
percent*
|
33 percent
|
1 Primary endpoint, *p-value vs. placebo
<0.001
VENTURE Data
Summary, Continued
|
|
Difference between
300 mg DUPIXENT (n=103) vs. Placebo (n=107)
(Overall
population)
|
Difference between
300 mg DUPIXENT (n=48) vs. Placebo (n=41)
(Patients with 300
eosinophils/ microliter or greater)
|
Change in
annualized rate of severe asthma exacerbations over 24
weeks
|
59 percent
reduction*
|
71 percent
reduction±
|
Absolute (percent)
change in FEV1 from baseline to 24 weeks
|
220 mL (15
percent***) improvement*
|
320 mL (25
percent***) improvement±
|
*Nominal p-value vs. placebo <0.001, ±Nominal
p-value vs. placebo <0.005
***Data not included in NEJM publication
For the 24-week treatment period, the overall rate of adverse
events was similar across treatment groups (62 percent in the
DUPIXENT-treated group and 64.5 percent in the placebo-treated
group). The rate of serious adverse events was 9 percent in the
DUPIXENT-treated group and 6 percent in the placebo-treated group.
The most frequent adverse events that occurred more frequently with
DUPIXENT treatment vs. placebo were injection site reaction (9
percent vs. 4 percent, respectively), bronchitis (7 percent vs. 6
percent, respectively), sinusitis (7 percent vs. 4 percent,
respectively) and eosinophilia (14 percent vs. 1 percent,
respectively).
Dupilumab Development Program
Sanofi and Regeneron are
also studying dupilumab in a broad range of clinical development
programs for diseases driven by Type 2 inflammation, including
pediatric atopic dermatitis (Phase 3), nasal polyps (Phase 3) and
eosinophilic esophagitis (Phase 2). Future trials are planned for
chronic obstructive pulmonary disease, grass allergy and food
allergy (including peanut). These potential uses are
investigational and the safety and efficacy have not been evaluated
by any regulatory authority. Dupilumab was discovered using
Regeneron's proprietary VelocImmune® technology
that yields optimized fully-human antibodies, and is being jointly
developed by Regeneron and Sanofi under a global collaboration
agreement.
For more information on dupilumab clinical trials please visit
www.clinicaltrials.gov.
About DUPIXENT® (dupilumab)
DUPIXENT
is currently approved in the U.S. for the treatment of adults with
moderate-to-severe atopic dermatitis whose disease is not
adequately controlled with topical prescription therapies, or when
those therapies are not advisable. DUPIXENT is also approved for
use in certain patients with moderate-to-severe atopic dermatitis
in the EU and a number of other countries, including Canada and Japan.
IMPORTANT SAFETY INFORMATION AND INDICATION
Do
not use if you are allergic to dupilumab or to any of the
ingredients in DUPIXENT®.
Before using DUPIXENT, tell your healthcare provider about
all your medical conditions, including if you:
- have eye problems
- have a parasitic (helminth) infection
- have asthma
- are scheduled to receive any vaccinations. You should not
receive a "live vaccine" if you are treated with DUPIXENT.
- are pregnant or plan to become pregnant. It is not known
whether DUPIXENT will harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known
whether DUPIXENT passes into your breast milk.
Tell your healthcare provider about all the medicines you take,
including prescription and over-the-counter medicines, vitamins and
herbal supplements. If you have asthma and are taking asthma
medicines, do not change or stop your asthma medicine without
talking to your healthcare provider.
DUPIXENT can cause serious side
effects, including:
- Allergic reactions. Stop using DUPIXENT and go to the
nearest hospital emergency room if you get any of the following
symptoms: fever, general ill feeling, swollen lymph nodes, hives,
itching, joint pain, or skin rash.
- Eye problems. Tell your healthcare provider if you have
any new or worsening eye problems, including eye pain or changes in
vision.
The most common side effects include injection site
reactions, eye and eyelid inflammation, including redness, swelling
and itching, and cold sores in your mouth or on your
lips.
Tell your healthcare provider if you have any side effect that
bothers you or that does not go away. These are not all the
possible side effects of DUPIXENT. Call your doctor for medical
advice about side effects. You may report side effects
to FDA at 1-800-FDA-1088.
Use DUPIXENT exactly as prescribed. If your healthcare provider
decides that you or a caregiver can give DUPIXENT injections, you
or your caregiver should receive training on the right way to
prepare and inject DUPIXENT. Do not try to inject
DUPIXENT until you have been shown the right way by your healthcare
provider.
Please click here for the full
Prescribing Information. The patient information is
available here.
INDICATION
DUPIXENT is used to treat adult patients
with moderate-to-severe atopic dermatitis (eczema) that is not well
controlled with prescription therapies used on the skin (topical),
or who cannot use topical therapies. DUPIXENT can be used with or
without topical corticosteroids. It is not known if DUPIXENT is
safe and effective in children. DUPIXENT is administered by
subcutaneous injection at different injection sites every two weeks
after an initial loading dose. DUPIXENT is intended for use under
the guidance of a healthcare provider. A patient may self-inject
DUPIXENT after training in subcutaneous injection technique using
the pre-filled syringe.
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 six 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 disease, heart disease, allergic and inflammatory
diseases, pain, cancer, 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.
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 news 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
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therapeutic applications of Regeneron's products, product
candidates, and research and clinical programs now underway or
planned, including without limitation DUPIXENT® (dupilumab)
Injection; the likelihood, timing, and scope of possible regulatory
approval and commercial launch of Regeneron's late-stage product
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dupilumab for the treatment of inadequately controlled
moderate-to-severe asthma (including possible regulatory approval
of dupilumab in the United States,
Japan, and the European Union
referenced in this news release), pediatric atopic dermatitis,
nasal polyps, eosinophilic esophagitis, chronic obstructive
pulmonary disease, food allergy and other potential indications;
the extent to which the results from the research and development
programs conducted by Regeneron or its collaborators may be
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the patent litigation proceedings relating to Praluent®
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Form 10-Q for the quarterly period ended March 31, 2018. Any forward-looking statements
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Regeneron
Contacts:
Media
Relations Sharon
Chen Tel: +1 (914)
847-1546 Sharon.Chen@regeneron.com
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Investor
Relations
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Narasimhan, Ph.D.
Tel: 1 (914)
847-5126
Manisha.Narasimhan@regeneron.com
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Sanofi
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