▎WuXiEdited by Kant Content Team

GSK today announced the full results of the Phase 3 clinical trials SWIFT-1 and SWIFT-2, which evaluated the efficacy and safety of the investigational monoclonal antibody depemokimab compared to placebo in adult and adolescent patients with severe asthma characterized by Type 2 inflammation (as indicated by blood eosinophil count). The analysis showed,Trial meets primary endpoint, therapy significantly reduces asthma attacks by 54% in patients.Detailed data were presented at the European Respiratory Society International Congress (ERSIC) and simultaneously published in The New England Journal of Medicine. According to the press release,Depemokimab may become the first approved ultra-long-acting biologic that requires dosing only once every 6 months for the treatment of severe asthma.

SWIFT-1 and SWIFT-2 are two identically designed, randomized, double-blind, placebo-controlled, parallel-group, multicenter Phase 3 clinical trials, with 375 and 380 patients enrolled respectively, lasting for 52 weeks. These two trials aim to evaluate the efficacy and safety of depemokimab as an adjunctive therapy. Enrolled patients were randomly assigned to receive either depemokimab or placebo, in addition to standard treatment consisting of medium to high-dose inhaled corticosteroids and at least one additional controller.

Analysis shows that both trials have reached the primary endpoint.Compared with placebo, the therapy significantly reduced the annualized rate of clinically significant deterioration (asthma attacks) in patients over 52 weeks.The pre-specified pooled analysis showed a significant 54% reduction in the rate of deterioration (HR=0.46, 95% CI: 0.36–0.59, p<0.001).

▲InPatients in the SWIFT-1 (upper) and SWIFT-2 (lower) trialsKaplan–Meier Analysis Results of the Time to First Asthma Attack (Image Source: Reference [2])

The trial also met the secondary endpoint.Compared with placebo,Patients experienced a 72% reduction in clinically significant deterioration requiring hospitalization or emergency treatment (HR=0.28, 95% CI: 0.13–0.61, p=0.002).In the trial, secondary endpoints assessing quality of life or patient symptom metrics showed improvement but did not reach statistical significance compared to placebo.

Image Source: 123RF

According to the press release,Depemokimab is the first ultra-long-acting biologic targeting interleukin-5 (IL-5) to be evaluated in a Phase 3 trial.Depemokimab can bind to IL-5 with high affinity and is administered once every six months for the treatment of severe asthma patients. IL-5 is a key cytokine in type 2 inflammation. Over 80% of severe asthma cases are caused by type 2 inflammation, characterized by elevated eosinophil levels, with unpredictable disease exacerbations.

References:

[1] Depemokimab late-breaking data presented at ERS show a 54% reduction in severe asthma exacerbations. Retrieved September 9, 2024 from https://www.gsk.com/en-gb/media/press-releases/depemokimab-late-breaking-data-presented-at-ers-show-a-54-reduction-in-severe-asthma-exacerbations/

[2] Jackson DJ, Wechsler ME, Jackson DJ, Bernstein D, Korn S, Pfeffer PE, Chen R, Saito J, de Luíz Martinez G, Dymek L, Jacques L, Bird N, Schalkwijk S, Smith D, Howarth P, Pavord ID; SWIFT-1 and SWIFT-2 Investigators. Twice-Yearly Depemokimab in Severe Asthma with an Eosinophilic Phenotype. N Engl J Med. 2024 Sep 9. doi: 10.1056/NEJMoa2406673. Epub ahead of print. PMID: 39248309.

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