AstraZeneca announced top-line results from two pivotal Phase 3 studies for benralizumab as adjunct to standard-of-care therapy for the treatment of severe asthma with an eosinophilic phenotype. Data were presented at the European Respiratory Society (ERS) International Congress and published in The Lancet.
The two trials, SIROCCO and CALIMA, are randomized, double-blind, parallel-group, placebo-controlled studies evaluating the efficacy and safety of benralizumab for up to 56 weeks in a total of 2,511 (n=1,205 in SIROCCO; n=1,306 in CALIMA) exacerbation-prone patients over 12 years old. Patients either received benralizumab 30mg SC every 4 weeks; benralizumab 30mg SC every 4 weeks for the first three doses followed by 30mg SC every 8 weeks; or placebo, in addition to their standard of care asthma treatments (eg, inhaled corticosteroids and long-acting beta 2 agonists [ICS/LABA]).
Results from the two studies demonstrated that adjunctive therapy with benralizumab significantly reduced exacerbations and improved lung function and asthma symptoms in patients with severe asthma with an eosinophilic phenotype. Treatment with either benralizumab dosing regimens reduced the annual rate of asthma exacerbations by up to 51% and improved lung function with a change in FEV1 of up to 159mL, which was seen 4 weeks after the first dose and sustained throughout the treatment period.
The studies found no additional benefits with the 4-week dosing vs. the 8-week dosing regimen, which may support less-frequent administration. No significant differences in safety profiles were observed between the benralizumab and placebo arms, with the most common adverse events including asthma, nasopharyngitis, upper respiratory infection, headache, and sinusitis. AstraZeneca intends to include detailed results from both trials for the benralizumab regulatory submissions later this year.
Benralizumab is a novel anti-eosinophil monoclonal antibody.
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