GSK’s Depemokimab Significantly Reduces Asthma Exacerbations

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Results from a pooled analysis of the Phase III SWIFT-1 and SWIFT-2 trials demonstrated that GSK’s depemokimab, a biologic targeting severe asthma with type 2 inflammation, significantly reduces exacerbations of the condition. GSK stated that the treatment is the first ultra-long-acting biologic for asthma to be evaluated in Phase III trials.¹

“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 hospitalization – the fundamental treatment goal in asthma,” said Kaivan Khavandi, SVP, global head, respiratory/immunology R&D, GSK, in a press release.

SWIFT-1 and SWIFT-2 were replicate 52-week, randomized, double-blind, placebo-controlled, parallel-group, multi-center clinical trials. These trials assessed the efficacy and safety of depemokimab adjunctive therapy in 382 and 380 participants, respectively, who were randomly assigned to receive depemokimab or a placebo. Additionally, participants received standard-of-care treatment with medium- to high-dose inhaled corticosteroids plus at least one additional controller. The primary endpoint was reduction in the annualized rate of clinically significant exacerbations over 52 weeks vs. placebo. The secondary endpoint was clinically significant exacerbations requiring hospitalization or emergency department visits compared to placebo.

Results revealed a 54% reduction in exacerbation rates among patients administered depemokimab compared to placebo over 52 weeks. In SWIFT-1, depemokimab reduced exacerbations requiring hospitalization by 72% and lowered exacerbations requiring hospitalization by 48% in SWIFT-2.

The incidence of adverse events (AEs) was similar in both trials. In SWIFT-1, 73% of both the depemokimab and placebo cohorts reporting AEs. In SWIFT-2, 72% of the depemokimab cohort reported an AE compared to 78% in the placebo cohort. The most frequently reported AEs were related to COVID-19, as the trial was conducted during a time of high COVID-19 prevalence.¹

According to the Asthma and Allergy Foundation of America, over 27 million people in the United States are currently living with asthma, equaling 22 million adults. It is more common in females, with 10.8% of women experiencing it compared to 6.5% of adult males. Currently, around 4.5 million US children are living with asthma. In 2021, 39.6% of adults aged 18 years and older reported having multiple asthma attacks in one year. However, Centers for Disease Control and Prevention statistics have shown that the rate of asthma attacks fell from 54% to 41% between 2001 and 2020.²

“As a physician, it is encouraging to see results of research that could evolve the management of severe asthma. For me, preventing exacerbations and particularly those that lead to hospitalizations is a treatment priority for the people I see with severe asthma. Not only are exacerbations traumatic for patients, and contribute to pressures on healthcare systems/hospitals, but each exacerbation can cause irreversible changes to the tissue of the lungs that over time can lead to permanent loss of lung function and make a patient’s breathing progressively more difficult,” said David Jackson, FRCP, MSc, PhD, lead author, SWIFT-1, SWIFT-2, professor of respiratory medicine, King’s College London, clinical lead, severe asthma, Guy’s and St Thomas’ Hospitals, London, in the press release.

References

1. Depemokimab late-breaking data presented at ERS show a 54% reduction in severe asthma exacerbations. GSK. September 9, 2024. Accessed September 10, 2024. 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. Asthma Facts. Asthma and Allergy Foundation of America. Accessed September 10, 2024. https://aafa.org/asthma/asthma-facts/#:~:text=Over%2027%20million%20people%20in,about%201%20in%2012%20people.&text=Over%2022%20million%20U.S.%20adults%20ages%2018%20and%20older%20have%20asthma.&text=Asthma%20rates%20are%20highest%20in,Native%20adults%20in%20the%20U.S.