MEDI 563 (benralizumab) achieves primary endpoint in two pivotal phase III trials for asthma with eosinophilic inflammation- AstraZeneca

AstraZeneca has announced that MEDI 563 (benralizumab) was well tolerated and achieved the primary endpoint in two pivotal Phase III registrational trials (SIROCCO and CALIMA), demonstrating significant reductions in the annual asthma exacerbation rate compared to placebo. The trials evaluated the efficacy and safety of two dose regimens of benralizumab as an add-on therapy for severe uncontrolled asthma with eosinophilic inflammation in adults and adolescents 12 years of age and older.

In SIROCCO and CALIMA, the primary analysis population included patients on high-dose inhaled corticosteroids (ICS) plus long-acting beta 2-agonist (LABA) with a baseline blood eosinophil count of at least 300 cells/microliter. Patients were randomised to receive benralizumab 30mg every 4 weeks; 30mg every 4 weeks for the first three doses followed by 30mg every 8 weeks; or placebo. The safety and tolerability findings for benralizumab were generally consistent with those reported in previous trials.

Comment: Benralizumab is an anti-eosinophil monoclonal antibody that depletes eosinophils via antibody-dependent cell-mediated cytotoxicity (ADCC), the process by which natural killer cells are activated to target eosinophils. Benralizumab induces direct, rapid, and near complete depletion of eosinophils in the bone marrow, blood and target tissue. Benralizumab was developed by MedImmune, AstraZeneca’s global biologics research and development arm. Results from the SIROCCO and CALIMA trials will be presented at a future medical meeting.