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Depemokimab late-breaking data presented at ERS
Depemokimab late-breaking data presented at ERS.
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Issued: 09 September 2024, London UK Depemokimab late-breaking data presented at ERS show a 54% reduction in severe asthma exacerbations · SWIFT-1 and SWIFT-2 phase III data show depemokimab delivered a statistically significant and clinically meaningful reduction in exacerbations over 52 weeks versus placebo plus standard of care, in duplicate studies · Ultra-long-acting biologic, depemokimab, administered once every six months produced sustained suppression of a key marker of type 2 inflammation, a driver of asthma attacks and hospitalisations · Data published simultaneously in the New England Journal of Medicine GSK plc (LSE/NYSE: GSK) today 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.1 The data were presented at the European Respiratory Society International Conference (7-11 September) 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 annualised rate of clinically significant exacerbations (asthma attacks) over 52 weeks versus placebo, with the pre-specified pooled analysis showing a significant 54% reduction in exacerbations [Rate Ratio 0.46, 95% CI, 0.36 - 0.59, p<0.001] (AER depemokimab = 0.51 exacerbations per year versus placebo = 1.11).1 In the pooled analysis of SWIFT-1 and SWIFT-2, there was a 72% reduction [RR 0.28, 95% CI 0.13 - 0.61, p=0.002] (AER: depemokimab = 0.02 versus placebo = 0.09) in the secondary endpoint of clinically significant exacerbations requiring hospitalisation or emergency department visit compared to placebo.1 As the pooled analysis of SWIFT-1 and SWIFT-2 did not control for multiple comparisons, results with a significant p-value (<0.05) 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.1 These data are part of G...