Physician Views: Can dupilumab, tezepelumab disrupt the severe asthma market?

New clinical data for Regeneron Pharmaceuticals and Sanofi's dupilumab (marketed already as Dupixent for atopic dermatitis), as well as Amgen and AstraZeneca's tezepelumab were unveiled last week, positioning both biologics as potential future therapies for the treatment of severe asthma.

Regeneron and Sanofi will submit a US regulatory application for dupilumab as a treatment for uncontrolled, persistent asthma by the end of 2017 based on results from the LIBERTY ASTHMA QUEST trial, both companies announced. Analysts have pegged approval in this indication as a key driver of revenue growth for dupilumab.

Amgen and AstraZeneca have announced promising Phase IIb data for tezepelumab, which demonstrated significantly and clinically meaningful reductions in exacerbation rate independent of baseline blood eosinophil count.

To gauge prescriber reaction to these data, we are snap-polling US and EU5-based pulmonologists with the following questions...

In the Phase 3 LIBERTY ASTHMA QUEST study, dupilumab – when added to standard therapies – reduced exacerbations and improved lung function in a broad population of patients with uncontrolled, persistent asthma. At 52 weeks, 300 mg dupilumab reduced severe asthma attacks by 46% in the overall population, 60% in patients with 150 eosinophilic cells/microliter or greater, and 67% in patients with 300 eosinophilic cells/microliter or greater. At 12 weeks, mean improvement in lung function over placebo as assessed by forced expiratory volume over one second (FEV1 ) was 130 mL (9%) in the overall population, 150 mL (11%) in patients with 150 eosinophilic cells/microliter or greater, and 240 mL (18%) in patients with 300 eosinophilic cells/microliter or greater.

How compelling are these data? (can you please select one 'rating' for each patient group please; so three in total)

Overall population – not compelling

Overall population – slightly compelling

Overall population – moderately compelling

Overall population – very compelling

Overall population – extremely compelling

≥150/µL – not compelling

≥150/µL – slightly compelling

≥150/µL – moderately compelling

≥150/µL – very compelling

≥150/µL – extremely compelling

≥300/µL – not compelling

≥300/µL – slightly compelling

≥300/µL – moderately compelling

≥300/µL – very compelling

≥300/µL – extremely compelling

In this study, 300 mg dupilumab was dosed every other week with a loading dose of 600 mg and injection site reactions were more common with dupilumab, occurring in 17 percent of dupilumab patients compared to 8% of placebo patients. Overall rates of adverse events, deaths, infections, conjunctivitis, herpes and discontinuations were comparable between the dupilumab and placebo groups. To what extent do you think these factors – dosing, injection site reaction, broad toxicity profile – would limit utilisation of dupilumab?

No impact

Slight impact

Moderate impact

Significant impact

Very significant impact

In the Phase IIb PATHWAY trial, tezepelumab demonstrated asthma exacerbation rate reductions of 61%, 71% and 66% versus placebo in patients receiving either 70 mg or 210 mg tezepelumab every four weeks or 280 mg tezepelumab every two weeks, respectively. Tezepelumab was given as an add-on therapy to patients with a history of asthma exacerbations and uncontrolled asthma despite receiving inhaled corticosteroids/long-acting beta-agonists with or without oral corticosteroids and additional asthma controllers. Significant and clinically meaningful reductions in the exacerbation rate were observed independent of baseline blood eosinophil count or other type 2 inflammatory biomarkers. Tezepelumab also demonstrated improvements in lung function at all doses and in asthma control at the two higher doses. The incidence of adverse events was similar between the tezepelumab and placebo groups.

How compelling are these data?

Not compelling

Slightly compelling

Moderately compelling

Very compelling

Extremely compelling

To what extent do you think tezepelumab would be differentiated from other biologic treatments for severe asthma if Phase III data replicated 'significant and clinically meaningful reductions in the exacerbation rate observed independent of baseline blood eosinophil count or other type 2 inflammatory biomarkers?'

Not differentiated

Slightly differentiated

Moderately differentiated

Very differentiated

Significantly differentiated

Caveating that the data for dupilumab and tezepelumab are from Phase III and Phase IIb studies, respectively, which product are you most excited about in terms of its potential impact in changing clinical practice for the treatment of severe asthma?

Dupilumab – marginally so

Dupilumab – moderately so

Dupilumab – significantly so

Tezepelumab – marginally so

Tezepelumab – moderately so

Tezepelumab – significantly so

Neither product

Results and related analysis will shortly be published for FirstWord Pharma PLUS subscribers to read, with the opportunity for non-FirstWord Pharma PLUS subscribers to purchase these findings. To be notified when poll results and analysis become available, please click here.

As always, FirstWord would very much like to receive your feedback and suggestions. Note: FirstWord Polls are powered by Medefield MedePolls, a fast-turnaround service to conduct instant polls of up to five questions with guaranteed samples that include physicians from dozens of specialties and over 100 markets. To conduct this poll with a different audience, or an entirely different poll, contact us at info@firstwordpharma.com.

To read more Physician Views articles, click here.