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Data presented at ATS 2016 support the use of biologics in severe refractory eosinophilic asthma, and will inform the stringent formulary access policies expected to be implemented by payers for these high-cost therapies.

A key theme of the American Thoracic Society (ATS) Conference, which was held in San Francisco, California, from 13–18 May 2016, was the use of newly approved and pipeline biologics in asthma patients with severe refractory eosinophilic asthma. Presentations and poster discussion sessions had a particular focus on providing data to establish competitive positioning, and to aid healthcare providers stratify responders to biologics, and therefore determine how to cost-effectively use these therapies.

There are currently three biologics approved for use in asthma in the US: Xolair (omalizumab; Roche/Novartis), Nucala (mepolizumab; GlaxoSmithKline), and Cinqair (reslizumab; Teva). Xolair, a monoclonal anti-immunoglobulin E antibody, held a unique position in the asthma market as the only approved biologic until Nucala, an anti-interleukin (IL)-5 therapy, gained US Food and Drug Administration approval in November 2015. In March 2016, Teva’s intravenous anti-IL-5 monoclonal antibody, Cinqair, also received US approval for use in asthma. Datamonitor Healthcare expects competition in the biologics class to increase over the next decade due to the anticipated launches of a number of other biologics, including benralizumab (AstraZeneca) as well as the subcutaneous formulation of Cinqair. Product differentiation in the marketplace is therefore critical for commercial success.

Data from a post-hoc analysis of Nucala’s Phase II DREAM and Phase III MENSA studies demonstrated that Nucala provided a clinically meaningful reduction in the rate of exacerbations in patients with severe eosinophilic asthma. This benefit was observed in patients eligible for treatment with Xolair, according to its US label, as well as in patients ineligible for treatment with Xolair. Datamonitor Healthcare believes that GlaxoSmithKline will leverage these data to drive Nucala’s use among patients who would have otherwise been treated with the first-to-market biologic.

New data presented on intravenous (IV) Cinqair demonstrate possible early endpoints associated with long-term efficacy, and highlight that Cinqair therapy is associated with a reduced need for systemic corticosteroid therapy, as well as a lower total rescue systemic corticosteroid burden. A poster session on Cinqair showed that early improvements in lung function or symptoms, as measured by forced expiratory volume in one second (FEV1) and improvements in the asthma control questionnaire-6 (ACQ-6) scores, are correlated with long-term exacerbation rate reductions. The poster focused on pooled efficacy data from two 52-week, placebo-controlled, Phase III studies in patients aged 12 years or older, who were inadequately controlled on inhaled corticosteroid regimens, and had an eosinophil count of ≥400/µL. The pooled data showed that 58% of the Cinqair-treated patients achieved an FEV1 response by week 16, with a corresponding exacerbation rate reduction relative to placebo of 71% by week 52. Similarly, 71% of the Cinqair-treated patients achieved an ACQ-6 response by week 16, with a corresponding exacerbation rate reduction relative to placebo of 61% by week 52. Exacerbation rate reductions for patients failing to achieve FEV1 or ACQ-6 were only 25% and 36%, respectively. Datamonitor Healthcare believes that the correlation between early improvements in lung function or symptoms, and long-term reductions in asthma exacerbation rates, could give healthcare providers a useful measure for stratifying responders to Cinqair therapy, and determining when to cost-effectively continue therapy with the biologic.

A second poster on Cinqair IV examining pooled data from the same 52-week, placebo-controlled, Phase III studies showed that patients with inadequately controlled asthma and elevated blood eosinophils treated with Cinqair received fewer new systemic corticosteroid prescriptions. These patients also had a lower total rescue systemic corticosteroid burden than patients in the placebo group. Only 29% of patients in the Cinqair group were prescribed systemic corticosteroids following first dosing of the drug, while 48% of patients in the placebo group were prescribed systemic corticosteroids. By week 52, the total rescue systemic corticosteroid burden was 290,977mg in the placebo group compared to only 121,135mg in the Cinqair group. The reduced need for long-term systemic corticosteroid therapy associated with Cinqair treatment boosts the drug’s clinical potential, as it also translates to a lower risk of long-term side effects, such as osteoporosis, weight gain, and Cushing’s syndrome.

A poster session on benralizumab, an anti-IL-5 receptor alpha monoclonal antibody, explored predictive biomarkers of response to benralizumab therapy. In the asthma space, such biomarkers are of great value in aiding healthcare providers to stratify use of high-cost therapies in patient populations in which they will be cost-effective, particularly in light of the availability of several relatively efficacious and low-cost inhaled therapies. The biomarkers examined were periostin (POSTN), eosinophil (Eos), and dipeptidyl peptidase (DPP)-4. Benralizumab was associated with an asthma exacerbation rate reduction of 48%, 45%, 45% in patients with high Eos, low POSTN, and low DPP-4, respectively. Conversely, benralizumab was associated with an asthma exacerbation rate reduction of 9%, 28%, 11% in patients with low Eos, high POSTN, and high DPP-4. Similar results were observed when patients were stratified by subsets of the biomarkers under examination, with the greatest reduction in exacerbations observed in patients with high Eos and low DPP-4 (57%).

Datamonitor Healthcare believes that data presented at ATS 2016, alongside subsequent studies expected to be published by manufacturers of biologic therapies, will inform the stringent formulary access policies payers will implement for these high-cost therapies.

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