GSK continues to advance the future of respiratory medicine and patient care with new data at ATS

• 40+ abstracts across GSK’s inhaled and respiratory biologics portfolio
• Additional analyses from the MATINEE trial expands body of evidence for the reduction of COPD exacerbations, emergency department visits and/or hospitalisations with mepolizumab
• Updated analyses evaluate the impact of twice-yearly dosing with depemokimab on asthma exacerbations, symptoms and quality of life among key patient subgroups

GSK plc (LSE/NYSE: GSK) today announced data from across its respiratory portfolio will be presented in 43 abstracts, including four late-breaking submissions, at the 2025 American Thoracic Society (ATS) International Congress in San Francisco (16 – 21 May). Key presentations aim to strengthen our understanding of optimal patient care to advance the prevention and treatment of diseases like asthma and chronic obstructive pulmonary disease (COPD).

Additional analyses from the MATINEE phase III trial

The MATINEE trial, recently published in The New England Journal of Medicine, assessed the efficacy and safety of mepolizumab in a wide spectrum of patients with COPD and type 2 inflammation, characterised by blood eosinophil count, including the most severe and difficult to treat as categorised in the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines.¹

New sub-analyses expand body of evidence from MATINEE by evaluating the rate of COPD exacerbations, including those that lead to emergency department visits and/or hospitalisation. Key patient subgroups of interest were assessed including those with cardiovascular comorbidities, varying severities of airflow obstruction, and with chronic bronchitis, emphysema-only or both. GSK will also present an analysis of the relationship between risk of severe exacerbation and healthcare burden in patients with COPD.

Sub-analyses from the SWIFT-1 and SWIFT-2 phase III trials

Updates from SWIFT-1 and SWIFT-2, the trials assessing the efficacy and safety of twice-yearly dosing of depemokimab in asthma with type 2 inflammation, characterised by blood eosinophil count, include a post hoc analysis of exacerbations and quality of life in patients with uncontrolled symptoms. Data from a new pooled assessment highlight improvements in overall health and risk of exacerbations resulting from sustained suppression of type 2 inflammation. Further analyses from the SWIFT programme explored geographical variation in asthma exacerbation rate, including in China, where patients did not have access to respiratory biologics at the time of the trial.

GSK will also present in a late-breaking session a first of its kind, real-world study evaluating the relationship between biologic adherence and clinical outcomes, specifically exacerbations and oral corticosteroid use.

Additional analyses demonstrate GSK ambition to lead advances in complex respiratory challenges

• Analyses supporting development of camlipixant to treat the continued burden of refractory chronic cough (RCC), including a model-based dose–response meta‑analysis evaluating reduction in taste disturbance side effects, seen across the P2X3 class, with camlipixant.
• A real-world European cohort study evaluating the ambition of clinical remission in patients with severe asthma treated with mepolizumab.

• New data showing the externally verified carbon footprints of salbutamol (also known as albuterol in the US) in the current metered dose inhaler (MDI) with propellant HFA-134a, a potential future MDI with next-generation candidate propellant HFA-152a, and a dry powder inhaler (DPI).

Full list of GSK’s key presentations at ATS 2025:

About mepolizumab

Mepolizumab is a monoclonal antibody that targets and binds to IL-5, a key messenger protein (cytokine) in type 2 inflammation. Mepolizumab has been developed for the treatment of a range of IL-5 mediated diseases associated with type 2 inflammation. It is currently approved for use in the US and Europe across four IL-5 mediated conditions. Mepolizumab is not approved for the treatment of COPD in any country. Regulatory submissions are under review in several countries, including the US, China and the EU. The US FDA has provided a PDUFA date of May 7, 2025.

For product and important safety information please consult the country relevant summary of product characteristics.

EU available at: https://www.ema.europa.eu/en/documents/product-information/nucala-epar-product-information_en.pdf.

About depemokimab

Depemokimab, a monoclonal antibody that targets IL-5, is the first ultra-long-acting biologic to be evaluated in phase III trials of patients with asthma with type 2 inflammation (SWIFT trials) or chronic rhinosinusitis with nasal polyps (CRSwNP) (the ANCHOR trials). Depemokimab's extended half-life, high-binding affinity and potency, supported six-month (26 week) dosing regimens in these trials, and demonstrated early and sustained inhibition of markers of type 2 inflammation and IL-5 activity. The phase III programme includes evaluation of depemokimab in other IL-5 mediated diseases including eosinophilic granulomatosis with polyangiitis (EGPA) and hypereosinophilic syndrome (HES). The first phase III trials in severe asthma, SWIFT-1 and SWIFT-2, have been reported and published in the The New England Journal of Medicine and the phase III trials in CRSwNP, ANCHOR-1 and ANCHOR -2 have been published in The Lancet. Depemokimab is an investigational product and is not approved for use in any country. Regulatory submissions are under review, including in the US, China, Japan and the EU.

About GSK in respiratory

GSK continues to build on decades of pioneering work to deliver more ambitious treatment goals, develop the next generation standard of care, and redefine the future of respiratory medicine for hundreds of millions of people with respiratory diseases. With an industry-leading respiratory portfolio and pipeline of vaccines, targeted biologics, and inhaled medicines, GSK is focused on improving outcomes and the lives of people living with all types of asthma and COPD along with less understood refractory chronic cough or rarer conditions like systemic sclerosis with interstitial lung disease. GSK is harnessing the latest science and technology with the aim of modifying the underlying disease dysfunction and preventing progression.

About GSK

GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com.

Cautionary statement regarding forward-looking statements

GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described in the “Risk Factors” section in GSK’s Annual Report on Form 20-F for 2024, and GSK’s Q1 Results for 2025.

References

[1] Hoffman M. Lung Disease & Respiratory Health. COPD Stages and the GOLD Criteria. WebMD. Available at: webmd.com/lung/copd/gold-criteria-for-copd. 14 May 2023. Last accessed April 2025.