Therapy Trends KOL Insight: Targeted Therapies in Asthma [2019]

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Publication Date:
January 2019
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Will new biologics stoke up competition in the targeted asthma treatment landscape?

Recent years have witnessed a rapid expansion in targeted treatments for severe asthma, and the landscape continues to evolve. Near term market dynamics will be driven by new data, delivery systems and expanded indications for Xolair, Nucala, Cinqair/Cinqaero and Fasenra. Dupixent, which recently secured US approval, could also represent a formidable competitor to the anti-IL5 mAbs. Looking further ahead, KOLs comment on how late-stage pipeline biologics tezepelumab and fevipiprant could shape the treatment algorithm, and they rate the potential of early-stage pipeline candidates targeting the IL-33/ST2 axis and IL-17.

Learn how the world’s leading asthma KOLs see the market evolving, how current products can protect market share, and how developers can differentiate their pipeline therapies in Therapy Trends KOL Insight: Targeted Therapies in Asthma. Ten North American and European KOLs provide candid insight on 5 marketed products and 7 pipeline programmes.

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Top takeaways

  • Since the approval of the first anti-IL5 mAb in 2015, Xolair has faced rapidly increasing competition from new market entrants. How significant will the impact of this be for Xolair and in which patient groups, if any, do KOLs believe Xolair might retain a dominant position?
  • GSK is conducting a Phase III study to evaluate whether cessation of Nucala therapy in patients that have received long-term treatment can be achieved without loss of symptom control. How do KOLs view this trial and do they believe the product can exert disease-modifying activity?
  • AstraZeneca’s Fasenra is supported by a substantial ongoing development programme. Which of the current Phase III trials (which include BORA, ANDHI MIRACLE and PONENTE) do KOLs consider to be of most relevance to prescribing practice?
  • The anti-IL4/IL13 mAb Dupixent was approved in the US in October 2018, but what key advantages does it deliver? Do KOLs feel that the product is sufficiently differentiated from the anti-IL5 mAbs and how well can it be expected to compete?
  • The anti-TSLP mAb tezepelumab has secured Breakthrough Therapy Designation in the US. Do the Phase II PATHWAY trial results suggest the potential to address currently unmet needs in the treatment of severe asthma?
  • IL-33 and its receptor (ST2) represent novel targets for the treatment of severe asthma. How optimistic are KOLs about this mechanism of action and is safety a concern?
  • Novartis is currently developing the anti-IL17 mAb CJM112 for the treatment of severe asthma. How confident are KOLs that targeting the IL-17 pathway will be an effective approach in treating severe asthma, and in which patient populations could an anti-IL17 therapy be best positioned?
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“Pathways and patient profiles are going to be key. For all these companies, it's going to be extremely important where their drug is going to be used and what type of patient, first line, second line. So, very much like in oncology.”
European Key Opinion Leader

“Maybe tezepelumab and anti-IL33 interference might eventually, in some patients, even cure asthma. Maybe we can administer some of these new compounds at a lower dose to patients with mild asthma in order to potentially cure them or at least keep them symptom-free for a much longer period of time.”
European Key Opinion Leader

“I certainly switch patients to the anti-IL5s, especially if they continue to have exacerbations and if they have eosinophil levels which are a good marker for responsiveness to anti-IL5 therapy. The randomised controlled data for exacerbation reduction is much stronger than for omalizumab.”
European Key Opinion Leader

Sample of therapies covered

Marketed/Registered Therapies

  • Xolair (omalizumab; Roche/Novartis)
  • Nucala (mepolizumab; GSK)
  • Cinqair/Cinqaero (reslizumab, Teva)
  • Fasenra (benralizumab; AstraZeneca)
  • Dupixent (dupilumab; Regeneron/Sanofi)

Pipeline Therapies

  • Tezepelumab (anti-TSLP; AstraZeneca/Amgen)
  • Fevipiprant (anti-CRTh2; Novartis)
  • REGN3500 (anti-IL33; Sanofi/Regeneron)
  • GSK3772847 (anti-ST2; GSK)
  • RG6149 (anti-ST2; Roche)
  • Etokimab (anti-IL33; AnaptysBio)
  • CJM112 (anti-IL17; Novartis)

KOLs interviewed

KOLs from North America

  • Leonard B. Bacharier, Professor of Pediatrics and Clinical Director, Division of Allergy, Immunology and Pulmonary Medicine at Washington University School of Medicine in St. Louis, MO, USA
  • Mark J. Fitzgerald, Director at the Centre for Heart and Lung Health at Vancouver Coastal Health Research Institute, Vancouver, Canada
  • Mitchell H. Grayson, Nationwide Children Hospital’s Chief of the Division of Allergy and Immunology for The Ohio State University Department of Pediatrics, Columbus, OH, USA
  • Gailen D. Marshall, Professor of Medicine and Pediatrics, Director, Division of Clinical Immunology and Allergy, University of Mississippi Medical Center, Jackson, MS, USA
  • Donald P. Tashkin, Professor of Medicine and Director, Pulmonary Function Laboratories, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA

KOLs from Europe

  • Peter J. Barnes, Professor of Thoracic Medicine and Head of Respiratory Medicine at the National Heart and Lung Institute and Honorary Consultant Physician at Royal Brompton Hospital, London, UK
  • Arnaud Bourdin, Professor and Head of General Pneumology, CHU de Montpellier, Montpellier, France
  • Kian Fan Chung, Professor of Respiratory Medicine, Royal Brompton Hospital, London, UK
  • Anonymous German KOL, Director at a leading research institute in Germany, specialising in asthma and respiratory medicine
  • Anonymous German KOL, Professor at a leading university in Germany, specialising in asthma and respiratory medicine

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