Press Release Source: Sanofi
(EURONEXT: SAN) (NYSE: SNY)
New England Journal of Medicine publishes two
positive Phase 3 trials showing Dupixent® (dupilumab) improved
moderate-to-severe asthma
- 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
Paris and Tarrytown, NY - May 21, 2018
-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.
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 requirement 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, ± p-value nominal2
Number of patients with FEV1 measurement at week 12
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/microliter or greater (vs. 43 percent for
placebo). Despite reductions in OCS, patients treated with Dupixent
reduced the risk of severe asthma attacks and improved their 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,
MD, 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 is being jointly developed by
Sanofi and Regeneron 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.
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.
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