Depemokimab Shown to Reduce Severe Asthma Exacerbations in Phase 3 Trials
Data from the SWIFT-1 and SWIFT-2 studies were presented by GSK at the European Respiratory Society International Conference.
Positive results have been announced from 2 phase 3 trials evaluating the efficacy and safety of depemokimab in adult patients with severe asthma and type 2 inflammation characterized by raised blood eosinophil count, GSK announced in a release.1 The data were presented at the European Respiratory Society International Conference.
Depemokimab Shown to Reduce Severe Asthma Exacerbations in Phase 3 Trials / gustavofrazao - stock.adobe.com
Data from SWIFT-1 (NCT04719832) and SWIFT-2 (NCT04718103) showed that depemokimab met its primary endpoint of annualized rate of clinically significant exacerbations over 52 weeks. The therapy also met the key secondary endpoint of clinically significant exacerbations requiring hospitalization or emergency department visit. For the secondary endpoints assessing quality-of-life and symptoms-based measures, depemokimab showed improvements but did not reach statistical significance. Data from the studies were published in The New England Journal of Medicine.2
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“As a physician, it is encouraging to see results of research that could evolve the management of severe asthma,” David Jackson, FRCP, MSc, PhD, lead author on both studies, said in a release.1 “For me, preventing exacerbations and particularly those that lead to hospitalizations is a treatment priority for the people I see with severe asthma. Not only are exacerbations traumatic for patients, and contribute to pressures on healthcare systems/hospitals, but each exacerbation can cause irreversible changes to the tissue of the lungs that over time can lead to permanent loss of lung function and make a patient’s breathing progressively more difficult.”
Depemokimab is an ultra-long-acting biologic that has high binding affinity and potency for interleukin-5 (IL-5), a key cytokine in type 2 inflammation. In patients with severe asthma, 80% exhibit type 2 inflammation as the underlying pathobiology of their disease. Depemokimab, which allows for 6-month dosing intervals, is the first of its kind to be evaluated in phase 3 trials.
SWIFT-1 and SWIFT-2 were replicate 52-week, randomized, double-blind, placebo-controlled, parallel-group, multi-center clinical trials. The duplicate phase 3 studies evaluated the efficacy and safety of depemokimab in adult patients with severe asthma and an eosinophilic phenotype characterized by a high eosinophil count, as well as a history of exacerbations despite the receipt of medium- or high-dose inhaled glucocorticoids.
The studies included 762 patients in total who randomly received depemokimab or a placebo, in addition to standard of care treatment with medium to high-dose inhaled corticosteroids plus at least 1 additional controller. SWIFT-1 included 382 patients, of which 250 received the therapy and 132 received placebo. SWIFT-2 included 380 patients, of which 252 received the therapy and 128 received placebo.
A pre-specified pooled analysis of the studies showed that depemokimab demonstrated a 54% reduction in the annualized rate of clinically significant asthma exacerbations. The therapy also showed a 72% reduction in clinically significant exacerbations requiring hospitalization or a visit to an emergency department. Additionally, the proportion of patients experiencing any adverse event was similar between the treatment and placebo groups.
“With a dosing schedule of just 2 injections per year, depemokimab has the potential to be the first approved ultra-long-acting biologic with 6-month dosing,” Kaivan Khavandi, SVP and global head of Respiratory/Immunology R&D at GSK, said in a release.1 “This could offer physicians and millions of patients with severe asthma an option that provides reassurance of sustained suppression of a key marker of type 2 inflammation and a reduction in the rate of exacerbations and hospitalization—the fundamental treatment goal in asthma.”
READ MORE: Respiratory Resource Center
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