Results from the Phase III ZONDA trial presented at the American Thoracic Society (ATS) 2017 International Congress demonstrated that adding benralizumab to standard of care allowed patients dependent on OCS to significantly reduce or discontinue steroids while maintaining asthma control.
Detailed results of the ZONDA study were published online in the New England Journal of Medicine.
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.
Dr. Parameswaran Nair, Professor of Respiratory Medicine at McMaster University in Hamilton, Canada and the lead investigator of the trial, said: “Benralizumab showed an impressive clinical efficacy by reducing exacerbations rate by up to 70% at the same time enabling patients with severe asthma to significantly lower their prednisone dose and maintain their lung function. This is likely due to its unique mechanism of action of inhibiting the receptor for interleukin-5 and potentially depleting blood and airway eosinophils.”
Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer, said: “One of the known clinical characteristics of the eosinophilic asthma phenotype is an over reliance on oral steroids to manage severe uncontrolled disease. What is exciting about the ZONDA trial is that we have shown benralizumab delivers a clinically meaningful OCS reduction alongside a substantial reduction in asthma exacerbation rate including emergency treatment or hospitalisations in this difficult-to-treat patient population.”
The ZONDA trial evaluated the effect of benralizumab 30 mg administered subcutaneously (SC) using either an 8- or 4-week dosing regimen for 28 weeks in adult patients with severe, uncontrolled eosinophilic asthma receiving high-dose inhaled corticosteroid (ICS)/long-acting beta2 agonist (LABA) and OCS with or without additional asthma controllers Benralizumab was well-tolerated, with an overall adverse event profile like that of placebo and that observed in previous Phase III trials. The most common adverse events (≥10%) in benralizumab-treated patients observed in ZONDA were nasopharyngitis, worsening asthma and bronchitis.