Targeted Therapies in Asthma: Update Bulletin [July 2017]

This edition presents the views and insights from three key opinion leaders (KOLs) from the US and Europe on a variety of recent events in the severe asthma treatment landscape. Topics covered include; Novartis announcing the results from the 'Still Fighting for Breath' survey which demonstrates that despite the widespread availability of oral and inhaled treatments, asthma still places a huge burden on the personal and professional lives of those living with the disease in Europe. Critically, data from the surveys shows that 94 percent of severe allergic asthma patients were unable to fully control their disease; AstraZeneca presenting data from the Phase III ZONDA trial, which demonstrated that adding benralizumab (a fully humanised anti-interleukin [IL]-5 monoclonal antibody) to standard of care allowed patients dependent on oral corticosteroids (OCS) to significantly reduce or discontinue steroids while maintaining asthma control. The trial achieved its primary efficacy endpoint, demonstrating a statistically significant and clinically relevant reduction in daily maintenance OCS use with two benralizumab dosing regimens compared with placebo, and also demonstrated significant outcomes for secondary endpoints; Teva presenting new data on Cinqair/Cinqaero (reslizumab), an anti-IL-5 mAb approved in the US and Europe as add-on maintenance treatment for patients with severe asthma aged 18 years and older, and with an eosinophilic phenotype. New data comes from a post-hoc pooled analysis of the Phase III BREATH study, and studies on the efficacy of reslizumab in patients eligible for Xolair (omalizumab; Roche/Novartis).

Business Questions:

• Were KOLs surprised by the data from the ‘Still Fighting for Breath’ survey, and do they believe any lessons can be learned?
• Could differences in access to therapy in each European country that took part in the ‘Still Fighting for Breath’ survey make data interpretation very challenging, or can the findings be taken at face value?
• Do KOLs believe that the data from the ‘Still Fighting for Breath’ survey will have any impact on how severe asthma is treated, and do they believe the GINA (The Global Initiative for Asthma) guidelines need to be modified? 
• Is more head to head data needed for biologic therapies that better ways of controlling exacerbations can be found, or is it simply a case of better education and better use of current treatments?
• What was most impressive about the data from the Phase III ZONDA study for benralizumab; changes in steroid usage, hospitalisation rates, exacerbation rates, or all of the above?
• Will benralizumab’s mechanism of action, steroid-sparing ability, and dosing schedule could help drive clinical differentiation?
• How will benralizumab be used in the treatment of severe eosinophilic asthma, and what challenges face AstraZeneca in terms of differentiating benralizumab from other anti-IL-5 mAbs?
• Are formulation problems preventing reslizumab from capturing significant market share in the US, or are other forces at play?
• What does the future hold for the use of biologics in the treatment of severe asthma?