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Targeted Therapies in Asthma: KOL Insight (2017)

Product Code:
596200732
Publication Date:
January 2017
Format:
PDF
Price:
£6,295

Latest Update

This edition presents key opinion leader (KOL) views on recent developments in the targeted asthma treatment market. Topics covered include; GlaxoSmithKline’s (GSK) presentation of new data at the American Academy of Allergy, Asthma & Immunology Annual Meeting (AAAAI 2017) which demonstrates that efficacy of mepolizumab (Nucala) is not affected by the presence of nasal polyps (which can be indicative of a recalcitrant asthma phenotype), and new data for mepolizumab from the Phase III MUSCA trial is also discussed. Teva’s presentation at AAAAI 2017 of new data showing that patients with inadequately controlled asthma and aspirin sensitivity received significant clinical improvement in asthmatic symptoms with reslizumab (Cinqiar/Cinqaeor) therapy. Roche/Genentech’s publication of ‘real world’ data from the PROSPERO study involving omalizumab (Xolair), with outcomes reflecting reductions in exacerbation frequency and hospitalisations achieved in earlier controlled clinical trials.

*Latest* Update 1: April 2017
Original Publication: Jan 2017
*Purchase of this report includes all updates*

This update tackles these key questions

  • In March 2017, GSK presented new data at AAAAI 2017 which demonstrates that mepolizumab’s efficacy is not affected by the presence of nasal polyps, but what is the significance of this data and what impact will it have on prescribing practice?
  • At AAAAI 2017, Teva presented data showing that patients with inadequately controlled asthma and aspirin sensitivity received significant improvement in symptoms with reslizumab therapy, but what is the prevalence of aspirin sensitivity and how will the data influence prescribing practice?
  • GSK and Teva have both published results from meta-analysis of Phase III studies that prove efficacy of mepolizumab and reslizumab respectively in a subgroup of patients acknowledged to be recalcitrant to standard therapies, but which of these products will be most appealing to prescribers and patients?
  • In March 2017, GSK published new data from the Phase III MUSCA study demonstrating mepolizumab’s efficacy in the treatment of severe asthma with an eosinophilic phenotype; primary outcomes, for the first time, included patient reported quality of life improvements. What is the impact of this data and can mepolizumab usage be expected to increase?
  • Roche/Genentech published new data from the PROSPERO study that confirms omalizumab’s efficacy in treating allergic asthma in a ‘real world’ setting. How is this data likely to be received amongst prescribers and will omalizumab usage increase?

Original Publication: As new targeted asthma therapies emerge, is time running out for Xolair?

Xolair’s unique position in the targeted asthma treatment market is under threat. Teva’s Cinqair and GSK’s Nucala have emerged as significant threats to Xolair’s dominance. What can Roche and Novartis do to stop the rot? Will clinical data save the day, or will commercial tactics be the critical difference in a rapidly evolving market? Learn how key opinion leaders (KOLs) see the market evolving, and how they expect developers to differentiate their pipeline asthma antibodies in KOL Insight: Targeted Therapies in Asthma. Twelve US and European KOLs give their insight on three marketed products and 8 pipeline programmes. KOLs also provide their candid views on the potential for Xolair biosimilars, and what it would take for these products to gain traction in the targeted asthma treatment market.

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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. Find out what they are.
  • How important is Xolair’s paediatric label extension, and will it support future clinical differentiation? KOLs provide their insights on Xolair’s expanded labelling to include paediatric patients, but will it mean anything clinically? And do KOLs expect long-term Xolair therapy to have any disease-modifying activity in this patient cohort?
  • Do current and emerging anti-IL5 mAbs represent a clinically significant advancement in the treatment of severe asthma? Nucala (mepolizumab) represents the first mAb to receive approval for severe asthma in over a decade. Other anti-IL5 mAbs are in development (e.g. AstraZeneca’s benralizumab). But will targeting this pathway improve clinical outcomes in severe asthma? Find out what KOLs think.
  • What pipeline programmes are KOLs becoming particularly excited about? Are next-generation anti-IL5 mAbs set to change the course of the severe asthma treatment market, or will it be Regeneron/Sanofi’s anti-IL-4/IL-13 mAb, dupilumab? Find out what KOLs are monitoring, and what they hope late-stage clinical studies will tell them.
  • Biosimilar versions of omalizumab are coming, but what impact will they have on the market? Xolair biosimilars are in development and could come to certain markets by 2018. What do KOLs think about these products, and how important will clinical studies proving equivalent safety and efficacy be in driving uptake? Moreover, how can Xolair biosimilars help cut the cost of treating severe asthma, an issue which many KOLs believe is limiting patient access and negatively impacting patient care.
  • 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.

Quotes

“The concept of biosimilars is going to be a big challenge. They don’t have a lot in the peer review literature to really give us a sense of the efficacy that they’re going to provide. I think it’s hard to make a definitive statement around those.”
US Key Opinion Leader

“There will be patients that are treated better with Xolair, we will have patients that are treated only with Nucala, but we will have patients that are eligible for both. We switch uncontrolled Xolair patients to Nucala, and some patients have to switch back to Xolair because Nucala, despite their eosinophilia of 300 or 400, is not as effective as Xolair, and vice versa.”
European Key Opinion Leader

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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 Gailen D. Marshall, MD, PhD, Professor of Medicine and Pediatrics, Director, Division of Clinical Immunology and Allergy, The University of Mississippi Medical Center MS, USA
  • Dr Reynold A. Panettieri, MD, Professor of Medicine, Perelman School of Medicine, University of Pennsylvania PA, USA
  • Dr Mike E. Wechsler MD, MMSc, Associate Physician, Brigham and Women's Hospital, Assistant Professor of Medicine, Harvard Medical School, Boston, MA, USA
  • Anonymous US KOL, internal medicine expert specialising in asthma

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
  • Anonymous French KOL, Professor at leading university in France
  • Anonymous German KOL, Professor at a leading university in Germany
  • Anonymous German KOL, Professor at a leading university in Germany
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