GSK presents full results from SWIFT-1 and SWIFT-2 Phase 3 trials

GSK presented the full results from the SWIFT-1 and SWIFT-2 phase III clinical trials which assessed the efficacy and safety of depemokimab versus placebo in adults and adolescents with severe asthma with type 2 inflammation characterised by raised blood eosinophil count. The data were presented at the European Respiratory Society International Conference in Vienna, Austria and simultaneously published in the New England Journal of Medicine. SWIFT-1 and SWIFT-2 are duplicate studies with the same primary and secondary endpoints. Both trials met their primary endpoints with statistically significant reductions in the annualized rate of clinically significant exacerbations over 52 weeks versus placebo, with the pre-specified pooled analysis showing a significant 54% reduction in exacerbations. In the pooled analysis of SWIFT-1 and SWIFT-2, there was a 72% reduction in the secondary endpoint of clinically significant exacerbations requiring hospitalisation or emergency department visit compared to placebo. As the pooled analysis of SWIFT-1 and SWIFT-2 did not control for multiple comparisons, results with a significant p-value are termed nominally significant. In the individual trials, the secondary endpoints assessing quality-of-life or the symptoms-based measure, showed improvements but did not reach statistical significance versus placebo. “These data are part of GSK‘s aspirations to advance treatment goals for those with severe asthma. Preventing exacerbations, a known risk for hospitalisation, and cause of cumulative lung damage and disease progression, has been a longstanding goal of asthma treatment and care. Sustained suppression of type 2 inflammation, an underlying driver of exacerbations, could help change the course of disease.3 Extended dosing intervals could also help tackle other barriers to optimal outcomes such as adherence or frequent healthcare appointments,” the company stated. Kaivan Khavandi, SVP, Global Head of Respiratory/Immunology R&D, said: “With a dosing schedule of just two injections per year, depemokimab has the potential to be the first approved ultra-long-acting biologic with six-month dosing. 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 hospitalisation – the fundamental treatment goal in asthma.”