Press Release: Dupixent® significantly reduced COPD exacerbations
in second positive Phase 3 trial, accelerating FDA submission and
confirming potential to become first approved biologic for this
serious disease
Dupixent® significantly reduced COPD exacerbations in second
positive Phase 3 trial, accelerating FDA submission and confirming
potential to become first approved biologic for this serious
disease
- NOTUS trial met its primary
endpoint with overwhelming efficacy, showing Dupixent significantly
reduced exacerbations by 34% compared to placebo in patients with
moderate-to-severe COPD with evidence of type 2 inflammation (ie,
blood eosinophils ≥300 cells per μL), confirming results from the
landmark BOREAS pivotal trial
- Dupixent rapidly and significantly
improved lung function (139 mL in FEV1) compared to placebo (57 mL
in FEV1) at 12 weeks
- Supplemental BLA submission planned
by end of 2023
- Approximately 300,000 people in the
U.S. alone live with uncontrolled COPD with evidence of type 2
inflammation; no new treatment approaches approved for more than a
decade
Paris and Tarrytown, N.Y. November 27,
2023. The second Dupixent® (dupilumab) investigational
Phase 3 chronic obstructive pulmonary disease (COPD) trial (NOTUS)
has shown that Dupixent significantly reduced (34%) exacerbations,
confirming positive published results from the landmark Phase 3
BOREAS trial. The NOTUS trial also confirmed that treatment with
Dupixent led to rapid and significant improvements in lung function
by 12 weeks and were sustained at 52 weeks. The NOTUS trial
evaluated the investigational use of Dupixent compared to placebo
in adults currently on maximal standard-of-care inhaled therapy
(triple therapy) with uncontrolled COPD and evidence of type 2
inflammation (i.e., blood eosinophils ≥300 cells per μL). These
results were from an interim analysis and, given the overwhelming
positive efficacy of the primary endpoint, will be considered the
primary analysis of the trial. Sanofi and Regeneron plan to submit
the data from this replicate trial, along with positive results
from the Phase 3 BOREAS trial, to the U.S. Food and Drug
Administration (FDA) by the end of the year.
Naimish Patel, M.D. Head of
Global Development, Immunology and Inflammation at Sanofi “This is
the first and only time an investigational biologic in COPD has
shown a significant and clinically meaningful reduction in
exacerbations in two Phase 3 trials and we are pleased that we can
potentially deliver Dupixent faster to patients in need where no
new advancements have been identified in over a decade. These data
validate our belief that Dupixent has the potential to transform
the treatment of moderate-to-severe COPD and given the significant
unmet needs for patients with uncontrolled COPD, we are not
stopping with Dupixent. Our second program in COPD, itepekimab,
continues with data expected in 2025. If positive, Dupixent and
itepekimab could emerge as treatments for approximately 80% of
those suffering from moderate-to-severe COPD with recurrent
exacerbations.”
Earlier this year, the FDA granted Breakthrough
Therapy designation for Dupixent as an add-on maintenance treatment
in adult patients with uncontrolled COPD associated with a history
of exacerbations and an eosinophilic phenotype based on the
positive results from BOREAS.
George D. Yancopoulos, M.D.,
Ph.D. Board Co-Chair, President and Chief Scientific
Officer at Regeneron“We are highly encouraged by these remarkable
results from NOTUS showing a 34% reduction in COPD exacerbations
compared to placebo, confirming the unprecedented results from our
first Phase 3 trial, BOREAS. These results demonstrate the
important role of type 2 inflammation in yet another chronic and
debilitating disease, and the ability of Dupixent to address this
inflammation. We are working to submit these data rapidly to the
FDA.”
The NOTUS trial included 935 adults who were
current or former smokers aged 40 to 85 years and randomized to
receive Dupixent (n=470) or placebo (n=465), which was added to
maximal standard-of-care inhaled therapy. Patients receiving
Dupixent compared to placebo experienced:
- 34% reduction in moderate or severe
acute COPD exacerbations over 52 weeks (p=0.0002), the primary
endpoint.
- Improved lung function from
baseline by 139 mL at 12 weeks compared to 57 mL for placebo
(p=0.0001), with the benefit versus placebo sustained at week
52 (115 mL for Dupixent versus 54 mL for placebo, p=0.0182), both
of which were key secondary endpoints.
The safety results were generally consistent
with the known safety profile of Dupixent in its approved
indications. Overall rates of adverse events (AE) were 67% for
Dupixent and 66% for placebo. AEs more commonly observed with
Dupixent (≥5% and ≥1% imbalance) compared to placebo included
COVID-19 (9.4% Dupixent, 8.2% placebo), nasopharyngitis (6.2%
Dupixent, 5.2% placebo), and headache (7.5% Dupixent, 6.5%
placebo). AEs more commonly observed with placebo compared to
Dupixent included COPD (7.8% placebo, 4.9% Dupixent). AEs leading
to deaths were 2.6% for Dupixent and 1.5% for placebo.
Detailed results from the NOTUS trial are
planned for presentation at a future scientific forum.
The efficacy results in NOTUS were consistent
with the previously announced results in BOREAS. BOREAS results
showed:
- 30% reduction in moderate or severe
acute COPD exacerbations over 52 weeks (p=0.0005), the primary
endpoint.
- Improved lung function from
baseline by 160 mL at 12 weeks compared to 77 mL for placebo
(p<0.0001), with the benefit versus placebo sustained through
week 52 (p=0.0003).
The safety results in NOTUS were also consistent
with those previously announced in BOREAS. Overall rates of AEs in
BOREAS were 77% for Dupixent and 76% for placebo. AEs more commonly
observed with Dupixent compared to placebo included headache (8.1%
Dupixent, 6.8% placebo), diarrhea (5.3% Dupixent, 3.6% placebo) and
back pain (5.1% Dupixent, 3.4% placebo). AEs more commonly observed
with placebo compared to Dupixent included upper respiratory tract
infection (9.8% placebo, 7.9% Dupixent), hypertension (6.0%
placebo, 3.6% Dupixent) and COVID-19 (5.7% placebo, 4.1% Dupixent).
AEs leading to deaths were 1.5% for Dupixent and 1.7% for
placebo.
The European Medicines Agency is reviewing
Sanofi and Regeneron’s application for Dupixent for the treatment
of uncontrolled COPD with type 2 inflammation; this application is
based on results from the BOREAS trial. Discussions with other
regulatory authorities around the world are ongoing.
The safety and efficacy of Dupixent in COPD are
currently under clinical investigation and have not been evaluated
by any regulatory authority.
About COPD
COPD is the third leading cause of death
worldwide and a life-threatening respiratory disease that damages
the lungs and causes progressive lung function decline. Symptoms
include persistent cough, breathlessness and excessive mucus
production that may not only impair the ability to perform routine
daily activities, but can also lead to anxiety, depression and
sleep disturbances. COPD is also associated with a significant
health and economic burden due to recurrent acute exacerbations
that require systemic corticosteroid treatment and/or lead to
hospitalization or even death. Smoking and exposure to noxious
particles are key risk factors for COPD, but even individuals who
quit smoking can still develop or continue having the disease. In
the U.S. alone, approximately 300,000 people live with uncontrolled
COPD with evidence of type 2 inflammation.
About the Dupixent COPD Phase 3 Trial
Program
NOTUS and BOREAS are replicate, randomized,
Phase 3, double-blind, placebo-controlled trials that evaluated the
efficacy and safety of Dupixent in adults who were current or
former smokers with moderate-to-severe COPD aged 40 to 85 years in
NOTUS and 40 to 80 years in BOREAS. Enrolling a total of 1,874
patients, all patients in NOTUS and BOREAS had evidence of type 2
inflammation, as measured by blood eosinophils ≥300 cells per µL.
Patients with a diagnosis or history of asthma were excluded from
the trials.
During the 52-week treatment period, patients in
NOTUS and BOREAS received Dupixent or placebo every two weeks added
to a maximal standard-of-care inhaled triple therapy of inhaled
corticosteroids (ICS), long-acting beta agonists (LABA), and
long-acting muscarinic antagonists (LAMA). Double maintenance
therapy, which included LABA and LAMA, was allowed if ICS was
contraindicated.
The primary endpoint for NOTUS and BOREAS
evaluated the annualized rate of acute moderate or severe COPD
exacerbations. Moderate exacerbations were defined as those
requiring systemic steroids and/or antibiotics. Severe
exacerbations were defined as those: requiring hospitalization;
requiring more than a day of observation in an emergency department
or urgent care facility; or resulting in death. Key secondary
endpoints included change from baseline in lung function (assessed
by pre-bronchodilator forced expiratory volume [FEV1]) at 12 and 52
weeks.
Data from BOREAS were published in the New
England Journal of Medicine.
About Sanofi and Regeneron’s COPD
Clinical Research Program
Sanofi and Regeneron are motivated to transform
the treatment paradigm of COPD by examining the role different
types of inflammation play in the disease progression through the
investigation of two potentially first-in-class biologics, Dupixent
and itepekimab.
Dupixent inhibits the signaling of the
interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and the
program focuses on a specific population of people with evidence of
type 2 inflammation. Itepekimab is a fully human monoclonal
antibody that binds to and inhibits interleukin-33 (IL-33), an
initiator and amplifier of broad inflammation in COPD. Across both
programs, four Phase 3 trials are ongoing and designed to inform
next-generation treatments for people with COPD who might not have
other options.
Itepekimab is currently under clinical
investigation and its safety and efficacy have not been evaluated
by any regulatory authority.
About Dupixent
Dupixent is a fully human monoclonal antibody
that inhibits the signaling of the interleukin-4 (IL-4) and
interleukin-13 (IL-13) pathways and is not an immunosuppressant.
The Dupixent development program has shown significant clinical
benefit and a decrease in type 2 inflammation in Phase 3 trials,
establishing that IL-4 and IL-13 are key and central drivers of the
type 2 inflammation that plays a major role in multiple related and
often co-morbid diseases. These diseases include approved
indications for Dupixent, such as atopic dermatitis, asthma,
chronic rhinosinusitis with nasal polyposis (CRSwNP), eosinophilic
esophagitis (EoE) and prurigo nodularis.
Dupixent has received regulatory approvals in
one or more countries around the world for use in certain patients
with atopic dermatitis, asthma, CRSwNP, EoE or prurigo nodularis in
different age populations. Dupixent is currently approved for one
or more of these indications in more than 60 countries, including
in Europe, the U.S. and Japan. Approximately 750,000 patients are
being treated with Dupixent globally.
Dupilumab Development
Program
Dupilumab is being jointly developed by Sanofi
and Regeneron under a global collaboration agreement. To date,
dupilumab has been studied across more than 60 clinical trials
involving more than 10,000 patients with various chronic diseases
driven in part by type 2 inflammation.
In addition to the currently approved
indications, Sanofi and Regeneron are studying dupilumab in a broad
range of diseases driven by type 2 inflammation or other allergic
processes in Phase 3 trials, including pediatric EoE, chronic
spontaneous urticaria, chronic pruritus of unknown origin, chronic
obstructive pulmonary disease with evidence of type 2 inflammation
and bullous pemphigoid. These potential uses of dupilumab are
currently under clinical investigation, and the safety and efficacy
in these conditions have not been fully evaluated by any regulatory
authority.
About RegeneronRegeneron is a leading
biotechnology company that invents, develops, and commercializes
life-transforming medicines for people with serious diseases.
Founded and led for 35 years by physician-scientists, Regeneron’s
unique ability to repeatedly and consistently translate science
into medicine has led to numerous FDA-approved treatments and
product candidates in development, almost all of which were
homegrown in Regeneron’s laboratories. Regeneron’s medicines and
pipeline are designed to help patients with eye diseases, allergic
and inflammatory diseases, cancer, cardiovascular and metabolic
diseases, hematologic conditions, infectious diseases, and rare
diseases.
Regeneron is accelerating and improving the
traditional drug development process through its 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 Regeneron,
please visit www.regeneron.com or follow Regeneron on LinkedIn.
About SanofiWe are an innovative global
healthcare company, driven by one purpose: we chase the miracles of
science to improve people’s lives. Our team, across some 100
countries, is dedicated to transforming the practice of medicine by
working to turn the impossible into the possible. We provide
potentially life-changing treatment options and life-saving vaccine
protection to millions of people globally, while putting
sustainability and social responsibility at the center of our
ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY
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