Phase III ZONDA trial of MEDI 563 (benralizumab) meets primary endpoint in asthma and is published in NEJM- AstraZeneca

Results from the Phase III ZONDA trial of MEDI 563 (benralizumab), from AstraZeneca, demonstrated that adding benralizumab to standard of care allowed patients dependent on oral corticosteroid therapy (OCS) to significantly reduce or discontinue steroids while maintaining asthma control. The trial achieved its primary efficacy endpoint, demonstrating statistically-significant and clinically relevant reduction in daily maintenance OCS use with two benralizumab dosing regimens compared with placebo. Patients treated with benralizumab were more than four times as likely to reduce their OCS dose than those in the placebo group. The median reduction in OCS dose was 75% for patients treated with benralizumab versus 25% with placebo.

The ZONDA trial demonstrated significant outcomes for secondary endpoints. For OCS reduction in the 8-week dosing regimen showed 66% of benralizumab-treated patients reduced OCS doses by at least 50% compared with 37% receiving placebo, 37% of benralizumab-treated patients reduced OCS doses by at least 90% compared with 12% receiving placebo and 52% of benralizumab-treated patients who were eligible to discontinue OCS per the trial protocol were able to stop OCS use completely, compared with 19% receiving placebo. Analysis of prevention or reduction of acute asthma events in benralizumab treated patients on the 8-week dosing regimen demonstrated a 70% reduction in overall annual exacerbation rate compared with placebo and a 93% reduction in exacerbations requiring emergency room visits or hospitalisations compared with placebo. Data were presented at the American Thoracic Society (ATS) 2017 International Congress. Detailed results of the ZONDA study were published online in the New England Journal of Medicine.

See: "Oral Glucocorticoid–Sparing Effect of Benralizumab in Severe Asthma."