Twice-Yearly Depemokimab Improves Peak Expiratory Flow and Asthma Symptoms

Depemokimab (GSK3511294; GSK) improves morning peak expiratory flow (PEF) and demonstrates favorable trends in daily asthma symptoms compared with placebo, according to research presented at the 2025 American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting.¹ These findings, which are from the phase 3a SWIFT-1 (NCT04719832)² and SWIFT-2 (NCT04718103)³ clinical trials, further support data from December 2024 published in The New England Journal of Medicine.^1,4

Depemokimab is an ultra-long-acting biologic with enhanced IL-5 binding affinity, high potency, and extended half-life, supporting twice-yearly dosing in patients living with asthma. The manufacturer reported in March 2025 that the FDA accepted for review the biologics license applications for the use of depemokimab as an add-on maintenance treatment for adult and pediatric patients aged 12 years and older with asthma with type 2 inflammation characterized by an eosinophilic phenotype on medium- to high-dose inhaled corticosteroids plus another asthma controller and adult patients with inadequately controlled chronic rhinosinusitis with nasal polyps.^1,5

SWIFT-1 and SWIFT-2 are randomized, placebo-controlled replicate phase 3a trials designed to evaluate the safety and efficacy of depemokimab in patients aged 12 years and older with severe asthma and an eosinophilic phenotype that is characterized by a high eosinophil count (300 cells or higher per microliter in the previous 12 months or 150 cells or higher per microliter at screening) with a history of exacerbations despite receiving medium- or high-dose inhaled glucocorticoids. Patients were randomly assigned to receive either depemokimab or a placebo.^2,3

Previous findings from the 2 trials demonstrated that depemokimab was successful in reducing the annualized rate of exacerbations, with exacerbations occurring in only 32% (n = 81; 124 and 159 events in SWIFT-1 and SWIFT-2, respectively) in both trials. Additionally, the proportion of patients reporting any adverse event (AE) was similar in the depemokimab and placebo groups in SWIFT-1 (73% in both groups) and SWIFT-2 (depemokimab: 72%; placebo: 78%). The study investigators noted that there were no serious AEs that were found to be related to either depemokimab or placebo.⁴

Regarding the current data presented at the 2025 ACAAI Annual Meeting, 459 patients were treated with depemokimab and 244 were treated with placebo. The findings indicated that depemokimab was associated with greater improvements in least squares mean change from baseline in morning PEF compared with placebo from week 1 to 2 (18.08 [95% CI, 14.16–22.01] vs 9.07 [95% CI, 3.65–14.48] L/min, respectively), with an overall treatment difference of about 9.02 (95% CI, 2.31–15.72). Of note, improvement was sustained until weeks 51 to 52 (23.66 [95% CI, 17.64–29.67] vs 7.81 [95% CI, 0.54–16.16], respectively), with a treatment difference of about 15.84 (95% CI, 5.54–26.15). Change from baseline in nighttime awakenings and daily rescue medication use was numerically reduced from weeks 1 to 2 and maintained until weeks 51 to 52, according to the investigators.¹

These findings, along with those from December 2024, support the efficacy of depemokimab when administered twice per year in patients with severe asthma. Although it demonstrates benefits in this patient population, further research will be needed to confirm its prolonged use and accessibility for patients.

REFERENCES

1. Katial R, Jacques L, Bird N, et al. Twice-yearly depemokimab improves peak expiratory flow and rescue inhaler use in patients with asthma: SWIFT-1/2. Ann Allergy Asthma Immunol. 2025;135(5, Supplement 1):S46–S47. doi:10.1016/j.anai.2025.08.149

2. Placebo-controlled Efficacy and Safety Study of GSK3511294 (Depemokimab) in Participants With Severe Asthma With an Eosinophilic Phenotype (SWIFT-1). ClinicalTrials.gov identifier: NCT04719832. Updated December 17, 2024. Accessed November 17, 2025. https://clinicaltrials.gov/study/NCT04719832

3. A Study of GSK3511294 (Depemokimab) in Participants With Severe Asthma With an Eosinophilic Phenotype (SWIFT-2). ClinicalTrials.gov identifier: NCT04718103. Updated November 29, 2024. Accessed November 17, 2025. https://clinicaltrials.gov/study/NCT04718103

4. McGovern G. Depemokimab Every 6 Months Reduces Rate of Severe Asthma Exacerbations. Pharmacy Times. January 3, 2025. Accessed November 17, 2025. https://www.pharmacytimes.com/view/depemokimab-every-6-months-reduces-rate-of-severe-asthma-exacerbations

5. GSK. Depemokimab applications accepted for review by the US FDA for asthma with type 2 inflammation and for chronic rhinosinusitis with nasal polyps (CRSwNP). News release. March 3, 2025. Accessed November 17, 2025. https://www.gsk.com/en-gb/media/press-releases/depemokimab-applications-accepted-for-review-by-the-us-fda/