AstraZeneca’s first biologic respiratory
medicine met primary and key secondary endpoints in pivotal trials
for severe asthma
Results from pivotal Phase III trials presented at the European
Respiratory Society (ERS) International Congress demonstrated that
adding benralizumab to standard-of-care medicine significantly
reduced exacerbations and improved lung function and asthma
symptoms in severe asthma patients with an eosinophilic phenotype,
as indicated by the presence of eosinophils in their blood.
The SIROCCO and CALIMA trials evaluated the effect of two dosing
regimens of benralizumab 30mg administered in 4-week and 8-week
regimens as add-on therapy to standard-of-care medicine across
primary and key secondary endpoints. Results showed:
- Reductions in the annual rate of asthma
exacerbations (up to 51%)
- Improvement in lung function (change in
FEV1 of up to 159 mL), which was seen at 4 weeks after the first
benralizumab dose and sustained throughout the treatment
period
- Improvement in asthma symptoms, such as
wheeze, cough, chest tightness and shortness of breath
The outcomes were demonstrated for the 8-week dosing regimen,
with no additional benefit observed with 4-week dosing, which may
support less-frequent dosing. In addition, post-hoc analysis
showed greater improvements in exacerbation rate reduction, FEV1
and total asthma symptom scores in patients with a history of more
frequent asthma exacerbations (≥ 3 in the previous year). Detailed
results were published today in The Lancet for the Phase III
SIROCCO and CALIMA trials.
Sean Bohen, Executive Vice President, Global Medicines
Development and Chief Medical Officer, said: “Severe asthma affects
the lives of millions of patients around the world and can be life
threatening. The SIROCCO and CALIMA Phase III trials have shown
that benralizumab can offer a meaningful treatment option for
patients as evidenced by reductions in exacerbations, improvement
in lung function and symptoms, with the promise of fewer doses a
year. Benralizumab has a unique way of working in patients with
severe asthma with an eosinophilic phenotype and reflects
AstraZeneca’s progress in bringing the next generation of
respiratory medicines to patients.”
The adverse event frequency was similar between
benralizumab-treated patients versus placebo-treated patients for
both SIROCCO and CALIMA (72% and 74% for all benralizumab treated
patients vs. 76% and 78% for placebo-treated patients observed in
SIROCCO and CALIMA, respectively). The most common (≥5%) adverse
events in benralizumab-treated patients observed in SIROCCO were
asthma, nasopharyngitis, upper respiratory infection, headache,
bronchitis, sinusitis, influenza and pharyngitis; and in CALIMA
were nasopharyngitis, asthma, bronchitis, upper respiratory tract
infection, headache and sinusitis.
Severe uncontrolled asthma is a debilitating and potentially
fatal form of the disease, where patients experience frequent
exacerbations every year and have significant limitations on lung
function and quality of life. Uncontrolled asthma can lead to a
dependence on oral corticosteroids (OCS), with systemic steroid
exposure leading to serious and irreversible adverse effects.
Benralizumab is an anti-eosinophil monoclonal antibody that
induces direct, rapid and near-complete depletion of eosinophils,
with an onset of action within 24 hours as confirmed in early phase
I/II trials. Eosinophils are the biological effector cells that
drive inflammation and airway hyper-responsiveness in approximately
50% of asthma patients, leading to frequent exacerbations, impaired
lung function and asthma symptoms.
The data from the SIROCCO and CALIMA trials will be included in
regulatory submissions for benralizumab that are planned for the US
and EU later in 2016.
NOTES TO EDITORS
About Severe Asthma
Asthma currently affects the health and day-to-day lifestyles of
315 million individuals worldwide, and by 2020 will likely increase
in numbers to as many as 400 million people. Up to 10% of asthma
cases are severe, of which approximately 40% remain uncontrolled on
current standard of care medicine. Severe, uncontrolled asthma has
an eight times higher risk of mortality than severe asthma.
Uncontrolled asthma can lead to a dependence on OCS. Systemic
steroid exposure can lead to serious and irreversible adverse
effects, including osteoporosis, anxiety, depression, weight gain,
glaucoma and diabetes. There is also a significant physical and
socio-economic burden of severe asthma with these patients
accounting for 50% of asthma-related costs.
About the WINDWARD Program
The WINDWARD program in asthma is made up of six Phase III
trials, including SIROCCO, CALIMA, ZONDA, BISE, BORA and GREGALE.
WINDWARD, the largest Phase III development program for a biologic
medicine in respiratory disease, evaluated a total of 3,068
patients in 798 sites across 26 countries.
The two pivotal trials, SIROCCO and CALIMA, are randomized,
double-blind, parallel-group, placebo-controlled trials designed to
evaluate the efficacy and safety of a regular, subcutaneous
administration of benralizumab (fixed 30 mg dose) for up to 56
weeks in exacerbation-prone adult and adolescent patients 12 years
of age and older.
A total of 2,511 patients (1,205 in SIROCCO and 1,306 in CALIMA)
currently receiving standard of care medicine (including
high-dosage inhaled corticosteroids and long-acting beta 2 agonists
[ICS/LABA]) were randomized globally and received either
benralizumab 30mg every 4 weeks; benralizumab 30mg every 4 weeks
for the first three doses followed by 30mg every 8 weeks; or
placebo. All benralizumab doses were administered via subcutaneous
injection using an accessorized pre-filled syringe.
In addition to WINDWARD, the Phase III VOYAGER program is
currently underway, which is evaluating the efficacy and safety of
benralizumab in patients with severe chronic obstructive pulmonary
disease (COPD).
About Benralizumab
Benralizumab was developed by MedImmune, AstraZeneca’s global
biologics research and development arm and is in-licensed from
BioWa, Inc., a wholly-owned subsidiary of Kyowa Hakko Kirin Co.,
Ltd.
About AstraZeneca in Respiratory Disease
Respiratory disease is one of AstraZeneca’s main
therapy areas, and we have a growing portfolio of medicines that
reached more than 17 million patients in 2015. Our aim is to
transform asthma and COPD treatment through inhaled
combinations at the core of care, biologics for the unmet needs of
specific patient populations, and scientific advancements in
disease modification. We are building on a 40-year heritage in
respiratory disease, and our capability in inhalation technology
spans both pressurized metered-dose inhalers (pMDIs) and dry powder
inhalers (DPIs), as well as our unique Co-SuspensionTM
Delivery Technology. Our research is focused on three key
biological pathways: eosinophilic disease, Th2-driven disease
and epithelial-driven pathobiology.
About AstraZeneca
AstraZeneca is a global, science-led biopharmaceutical company
that focuses on the discovery, development and commercialization of
prescription medicines, primarily for the treatment of diseases in
three therapy areas – Respiratory and Autoimmunity, Cardiovascular
and Metabolic Diseases, and Oncology. The company is also active in
inflammation, infection and neuroscience through numerous
collaborations. AstraZeneca operates in over 100 countries and its
innovative medicines are used by millions of patients worldwide.
For more information please visit: www.astrazeneca-us.com
3271601 Last Updated 9/16
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