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Targeted Therapies in Asthma: KOL Insight [2018]

Targeted Therapies in Asthma: KOL Insight [2018]

Introduction

Can new biologics breathe fresh competition into the targeted asthma treatment landscape?

The severe asthma treatment landscape is evolving. Near-term debates will focus on how best to use currently approved treatments, including Xolair, Nucala and Cinqair/Cinqaero, and which treatments offer the best for patients. Visible on the horizon is another anti-IL-5 mAb, AstraZeneca’s Fasenra (benralizumab), and by all accounts KOLs believe it could take the market by storm. Longer-term, Xolair biosimilars are looking large in the minds of KOLs, as are next-generation biologics such as AstraZeneca/Amgen’s tezepelumab, and an anti-TSLP mAb currently in mid-stage testing but already generating highly compelling data.

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 KOL Insight: Targeted Therapies in Asthma. Ten North American and European KOLs provide their insight on 3 marketed products and 10 pipeline programmes.

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The table of contents

The key business questions answered

The key KOL quotes

See the therapies covered

Find out who the 6 EU & 4 US KOLs are

Review an extract from the report - 1 drug profile

Top takeaways

Will Xolair (omalizumab) remain the treatment of choice for allergic asthma patients? Xolair may remain first-line-therapy for allergic asthma patients with elevated serum IgE levels, but for some patients other treatment options might be a better strategy. Moreover, omalizumab biosimilars are on the horizon. Find out what KOLs think about biosimilars, and how Xolair’s position in the treatment paradigm could change.

What have been the key changes to the anti-IL-5 mAb landscape, and how do KOLs see this class evolving? Nucala (mepolizumab) was the first mAb to receive approval for severe asthma in over a decade, but other anti-IL5 mAbs are gaining traction. Of these, KOLs are most excited about AstraZeneca’s Fasenra (benralizumab). Find out what’s exciting KOLs, and what companies behind currently marketed anti-IL-5s can do to protect market share.

What pipeline programmes are KOLs particularly excited about? Regeneron/Sanofi’s anti-IL-4/IL-13 mAb, dupilumab, is emerging as a potentially new treatment option for severe asthma, but its another pipeline programme that KOLs are raving about. Is it AstraZeneca/Amgen’s tezepelumab? Novartis’ fevipiprant? Or something else? Read the report to find out more.

What’s the future of biomarkers in identifying responsive patients? With precision medicine becoming a critical enabler of product use in a number of disease areas, find out what KOLs think about the use of biomarkers in defining eligible patient populations in the severe asthma market and how this could help eliminate “trial and error” approaches to treatment decisions.

With increasing number of biological therapies coming to market in the medium term, what will it take to succeed in the targeted asthma market? Competition for a limited pool of patients could eventually make the targeted asthma treatment landscape a less commercially attractive option for manufacturers developing new therapies in this field. What commercial strategies are KOLs advocating? As simple as strategic pricing, or are other strategies needed?

Quotes

“It’s got some advantages because it's got this unique mechanism of action, it’s different. So there's a story you can build on.” European Key Opinion Leader

“The thing about the anti-TSLP is that it's further up the food chain in the inflammatory cascade and it may, potentially, make the other compounds redundant. So I think it's very promising.” US Key Opinion Leader

Sample of therapies covered

Marketed/Registered Therapies

Xolair (omalizumab; Roche/Novartis)

Nucala (mepolizumab; GSK)

Cinqair/Cinqaero (reslizumab, Teva)

Pipeline/Pre-Registered Therapies

Benralizumab (anti-IL-5; AstraZeneca)

Fevipiprant (anti-CRTh2; Novartis)

Tralokinumab (anti-IL13; AstraZeneca)

Dupilumab (anti-IL-4/IL-13; Sanofi/Regeneron)

Risankizumab (anti-IL-23; Boehringer Ingelheim/AbbVie)

Tezepelumab (anti-TSLP; AstraZeneca/Amgen)

Xmab 7195 (anti-IgE/CD32b; Xencor)

Bertilimumab (anti-CCL11 chemokine; Immune Pharmaceuticals)

REGN 3500 (anti-IL-33; Sanofi/Regeneron)

FB 825 (Anti-CεmX; Fountain Biopharma)

KOLs interviewed

KOLs from North America

Dr Leonard B. Bacharier MD, Professor of Pediatrics and Clinical Director, Division of Allergy, Immunology and Pulmonary Medicine at Washington University School of Medicine in St. Louis, USA

Dr Mark J. Fitzgerald MD, Director at the Centre for Heart and Lung Health at Vancouver Coastal Health Research Institute, Vancouver, Canada

Dr Mike E. Wechsler MD, MMSc, Associate Physician, Brigham and Women's Hospital, Assistant Professor of Medicine, Harvard Medical School, Boston, MA, USA

Dr Mitchell Grayson MD, Nationwide Children Hospital’s Chief of the Division of Allergy and Immunology for The Ohio State University Department of Pediatrics, Columbus, Ohio, USA

KOLs from Europe

Professor Arnaud Bourdin, MD, Head of General Pneumology, CHU de Montpellier, Montpellier, France

Professor Andy Wardlaw, MD, Head of Department and Professor of Respiratory Medicine, Glenfield Hospital, Leicester, UK

Professor Kian Fan Chung, MD, Professor of Respiratory Medicine, Royal Brompton Hospital, London, UK

Professor Peter J Barnes, MD, 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

Anonymous German KOL, Professor at a leading university in Germany specialising in asthma and respiratory medicine

Anonymous German KOL, Professor at a leading university in Germany specialising in asthma, pulmonary medicine and critical care

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1. Executive summary
2. Research objectives
3. Research focus
3.1 Asthma patient populations
3.2 Asthma treatment protocols (by disease severity)
4. Disease overview; treatment goals, unmet needs and market challenges
4.1 Current treatment paradigm
4.1.1 The key objectives of treatment are to alleviate patient symptomatology
4.1.2 Effective steroid-sparing therapies remain a key unmet need
4.1.3 Poor adherence to treatment regimens is a significant underlying factor in uncontrolled asthma symptoms
4.1.4 Patients with non-T2 and Th2-low asthma lack effective treatment options
4.1.5 A better understanding of endotypes within type-2 asthma is needed and will lead to more effective utilisation of biological therapies
4.1.6 Premium pricing and the drain on healthcare resources are a significant limitation of biological therapies for the treatment of severe asthma
5. Marketed therapies
5.1 Xolair (anti-IgE; omalizumab; Roche/Novartis)
5.1.1 Key insights summary
5.2 Nucala (anti-IL-5; mepolizumab; GSK)
5.2.1 Key insights summary
5.3 Cinqair/Cinqaero (anti-IL-5; reslizumab; Teva)
5.3.1 Key insights summary
5.4 Fasenra (anti-IL-5; benralizumab; AstraZeneca)
5.4.1 Key insights summary
6. Late stage development programmes
6.1 Dupilumab (anti-IL-4/IL-13; Sanofi/Regeneron)
6.1.1 Key insights summary
6.2 Tralokinumab (anti-IL-13; AstraZeneca)
6.2.1 Key insights summary
6.3 Fevipiprant (CRTh2 antagonist; QAW039; Novartis)
6.3.1 Key insights summary
7. Early stage development programmes
7.1 Tezepelumab (anti-TSLP; AstraZeneca/Amgen)
7.1.1 Key insights summary
7.2 Risankizumab (anti-IL-23; Boehringer Ingelheim/AbbVie)
7.2.1 Key insights summary
8. Interesting early-stage mechanisms of action
8.1 Anti-IgE/CD32b targeting therapies
8.1.1 Key insights summary
8.2 Anti-CCL11 targeting therapies
8.2.1 Key insights summary
8.3 Anti-IL-33 targeting therapies
8.3.1 Key insights summary
8.4 Anti-CεmX targeting therapies
8.4.1 Key insights summary
9. Future treatment paradigm
9.1 Key insights summary
9.1.1 Biomarkers will remain an elusive goal in the bid to differentiate responsive patients
9.1.2 Clinical study design in severe asthma must focus on exacerbations and reduction in steroid usage
9.1.3 KOLs identify market access issues as a key concern for manufacturers launching biological therapies into the severe asthma market
9.1.4 Safety data will be an important factor in differentiating biological therapies
10. Conclusion
11. Appendix
11.1 KOL details
11.1.1 KOLs from North America
11.1.2 KOLs from the EU

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