Phase III trials of MEDI 563 (benralizumab) meet primary and secondary endpoints for severe asthma- Medimmune/AstraZeneca

Results from pivotal Phase III trials demonstrated that adding MEDI 563 (benralizumab), from Medimmune/Astrazeneca, 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 and 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 (at least 3 in the previous year). Detailed results were published in The Lancet for the Phase III SIROCCO and CALIMA trials. Data was also presented at the European Respiratory Society (ERS) International Congress.