Press Release: Dupixent® late-breaking data from NOTUS confirmatory
phase 3 COPD study presented at ATS and published in NEJM
Dupixent® late-breaking data from NOTUS
confirmatory phase 3 COPD study presented at ATS and published in
NEJM
- NOTUS results confirm landmark data
from the phase 3 BOREAS study and show Dupixent significantly
reduced exacerbations by 34% and improved lung function, compared
to placebo, in uncontrolled chronic obstructive pulmonary disease
(COPD) with evidence of type 2 inflammation
- Data support the potential of Dupixent
as the first new treatment approach in more than a decade and
first-ever targeted therapy for COPD
Paris and Tarrytown, N.Y. May 20,
2024. Late-breaking data were presented from the NOTUS
phase 3 study evaluating the investigational use of Dupixent®
(dupilumab) as an add-on maintenance treatment in adults with
uncontrolled COPD on maximal standard-of-care inhaled therapy
(nearly all on triple therapy) and evidence of type 2 inflammation
(i.e., blood eosinophils ≥300 cells per μL). The NOTUS study
confirmed the positive results demonstrated in the landmark phase 3
BOREAS study, with its data presented at a late-breaking session of
the 2024 American Thoracic Society (ATS) International Conference
and simultaneously published in the New England Journal of Medicine
(NEJM).
Surya Bhatt, M.D., MSPH
Professor at the University of Alabama at Birmingham, Division of
Pulmonary, Allergy, and Critical Care Medicine, and a co-principal
investigator of the study “In my more than 20 years of practice,
there have been limited advancements for patients struggling with
the debilitating effects of uncontrolled COPD, and too many
patients experience a vicious cycle of exacerbations that can
result in loss of lung function and greatly diminish their quality
of life. In NOTUS, dupilumab reduced exacerbations by a magnitude
never seen before with an investigational biologic in a phase 3
COPD clinical study. These comprehensive results reinforce that, if
approved, dupilumab could provide a first-of-its-kind medical
advancement for the COPD community.”
As presented and published, the NOTUS study met its
primary and key secondary endpoints. All patients were on
background maximal standard-of-care inhaled therapy (nearly all on
triple therapy). Patients receiving Dupixent (n=470) experienced
the following, compared to placebo (n=465):
- 34% reduction in moderate or
severe COPD exacerbations over 52 weeks (p<0.001), the
primary endpoint.
- More than two times greater
improvement in lung function (pre-bronchodilator FEV1)
from baseline at 12 weeks (139 mL vs. 57 mL; p<0.001), with an
improvement maintained at week 52 (115 mL vs. 54 mL; p=0.018),
secondary endpoints.
- Numerically greater
improvements in health-related quality of
life from baseline at 52 weeks, a secondary endpoint, as
defined by patient-reported outcomes (PRO) in the St. George’s
Respiratory Questionnaire (SGRQ).
- Numerically greater reductions
in respiratory symptom severity from baseline to 52 weeks,
a secondary endpoint, as defined by PROs in Evaluating Respiratory
Symptoms in COPD (E-RS).
The safety results were generally consistent with
the known safety profile of Dupixent in its approved indications.
Overall rates of adverse events (AEs) were 67% for Dupixent and 66%
for placebo. AEs more commonly observed with Dupixent than 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 than Dupixent
included COPD (7.8% placebo, 4.9% Dupixent). AEs leading to deaths
were 2.6% for Dupixent and 1.5% for placebo.
Dupixent is currently under Priority Review by the
US Food and Drug Administration as an add-on maintenance treatment
in certain adult patients with uncontrolled COPD with evidence of
type 2 inflammation. The target action date is June 27, 2024.
Regulatory submissions are also under review in the European Union
and China, and discussions with other regulatory authorities around
the world are ongoing.
The potential use of Dupixent in COPD is currently
under clinical development, and its safety and efficacy have not
been fully evaluated by any regulatory authority in this
setting.
About COPD
COPD is a respiratory disease that damages the
lungs and causes progressive lung function decline. Symptoms
include persistent cough, breathlessness and excessive mucus
production that may impair the ability to perform routine daily
activities, which may 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.
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. There have been no new treatment
approaches approved for more than a decade. In the US,
approximately 300,000 people live with uncontrolled COPD with
evidence of type 2 inflammation.
About the Dupixent COPD phase 3 study
program
BOREAS and NOTUS are replicate, randomized, phase
3, double-blind, placebo-controlled studies that evaluated the
efficacy and safety of Dupixent in adults who were current or
former smokers with moderate-to-severe COPD. Patients were aged 40
to 80 years in BOREAS and 40 to 85 years in NOTUS. All 1,874
patients enrolled in BOREAS and NOTUS 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 studies.
During the 52-week treatment period, patients in
BOREAS and NOTUS 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 BOREAS and NOTUS 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, change from baseline
at 52 weeks in SGRQ total score compared to placebo, and
safety.
Data from BOREAS were also 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.
Itepekimab is currently under clinical
investigation, with two phase 3 studies currently enrolling, 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 studies,
establishing that IL-4 and IL-13 are two of the key and central
drivers of the type 2 inflammation that plays a major role in
multiple related and often co-morbid diseases.
Dupixent has received regulatory approvals in more
than 60 countries in one or more indications including certain
patients with atopic dermatitis, asthma, chronic rhinosinusitis
with nasal polyposis (CRSwNP), eosinophilic esophagitis (EoE),
prurigo nodularis and chronic spontaneous urticaria (CSU) in
different age populations. More than 850,000 patients are being
treated with Dupixent globally.
Dupilumab Development
ProgramDupilumab is being jointly developed by Sanofi and
Regeneron under a global collaboration agreement. To date,
dupilumab has been studied across more than 60 clinical studies
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 studies, including 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 Regeneron
Regeneron (NASDAQ: REGN) is a leading biotechnology company
that invents, develops and commercializes
life-transforming medicines for people with serious diseases.
Founded and led by physician-scientists, our unique ability
to repeatedly and consistently translate science into
medicine has led to numerous approved treatments and product
candidates in development, most 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, neurological
diseases, hematologic conditions, infectious diseases, and
rare diseases.
Regeneron pushes the boundaries of scientific
discovery and accelerates drug development using our
proprietary technologies, such as VelociSuite®, which produces
optimized fully human antibodies and new classes of bispecific
antibodies. We are shaping the next frontier of medicine with
data-powered insights from the Regeneron Genetics
Center® and pioneering genetic medicine platforms, enabling us
to identify innovative targets and complementary approaches to
potentially treat or cure diseases.
For more information, please visit
www.Regeneron.com or follow Regeneron on LinkedIn, Instagram,
Facebook or X.
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 the world, is dedicated to
transforming the practice of medicine by working to turn the
impossible into the possible. We provide potentially life-changing
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Sanofi is listed on EURONEXT: SAN and NASDAQ:
SNY
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