A 12-month interim analysis of the AGILE Phase III open-label extension study confirms that twice-yearly depemokimab, an ultra-long-acting anti-IL-5 biologic, maintains a favorable safety and efficacy profile in patients with type 2 asthma. These findings reinforce previous data from the SWIFT-1 and SWIFT-2 trials, suggesting depemokimab could offer a long-term treatment option for asthma patients with elevated blood eosinophil counts (BEC).
The study enrolled 640 patients aged 12 and older who had completed either SWIFT trial and met baseline criteria, including a history of at least two exacerbations in the past year while receiving medium-to-high-dose inhaled corticosteroids. Of these, 629 patients received at least one dose of depemokimab in the open-label extension, with 47% completing the study and 49% still ongoing as of the interim data cutoff (June 14, 2024).
Adverse events (AEs) were reported in 63% of patients, with infections and infestations being the most common (43%). Serious AEs occurred in 7% of participants, but no deaths were reported. Injection-site reactions and systemic hypersensitivity events were rare, occurring in less than 1% of patients.
Efficacy findings remained consistent with prior SWIFT trial results. The overall annualized exacerbation rate was 0.47 (95% CI: 0.40–0.56), with similar rates for patients previously receiving depemokimab (0.46) and those transitioning from placebo (0.48).
These results highlight depemokimab’s sustained efficacy and well-tolerated safety profile in patients with type 2 asthma, supporting its potential as a durable treatment option requiring only twice-yearly administration.
