Clinical Trials

Date: 2017-05-22

Type of information: Presentation of results at a congress

phase: 3

Announcement: presentation of results at the American Thoracic Society (ATS) 2017 International Congress

Company: AstraZeneca (UK)

Product: benralizumab

Action mechanism: monoclonal antibody. Benralizumab is a monoclonal antibody directed at the alpha subunit of the interleukin-5 receptor (IL-5Ralpha) that depletes eosinophils, a key target cell in inflammatory respiratory disease. Emerging evidence shows that for patients with elevated eosinophil counts, treatment with an IL-5 inhibitor in addition to guideline-based strategies may improve their asthma control and decrease the frequency of asthma attacks. This antibody is in-licensed from BioWa, Inc., a wholly-owned subsidiary of Kyowa Hakko Kirin Co., Ltd. Under the exclusive license agreement, Kyowa Hakko Kirin/BioWa have exclusive development and commercialisation rights for benralizumab in Japan and certain countries in Asia. AstraZeneca has exclusive rights for benralizumab in all other countries including the US and Europe. BioWa is eligible for milestone payments and royalties related to the development and commercialisation of benralizumab in those countries.

Disease: asthma

Therapeutic area: Allergic diseases – Inflammatory diseases – Respiratory diseases

Country: Argentina, Bulgaria, Canada, Chile, France, Germany, Republic of Korea, Poland, Spain, Turkey,Ukraine, USA

Trial details: 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. (NCT02075255)

Latest news:

• • On May 22, 2017, AstraZeneca announced that 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.
• The ZONDA trial demonstrated significant outcomes for secondary endpoints. For OCS reduction in the 8-week dosing regimen:
• - 66% of benralizumab-treated patients reduced OCS doses by ?50% compared with 37% receiving placebo
• - 37% of benralizumab-treated patients reduced OCS doses by ?90% compared with 12% receiving placebo
• - 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:
• - 70% reduction in overall annual exacerbation rate compared with placebo
• - 93% reduction in exacerbations requiring emergency room visits or hospitalisations compared with placebo
• The most common adverse events (?10%) in benralizumab-treated patients observed in ZONDA were nasopharyngitis, worsening asthma and bronchitis.
• The data from the ZONDA trial, along with the pivotal Phase III SIROCCO and CALIMA trials, were included in regulatory submissions for benralizumab.  Benralizumab is under regulatory review in the US, EU, Japan and several other countries with a US PDUFA date during the fourth quarter of 2017.

 

Is general: Yes