Nucala Significantly Reduces Moderate to Severe Exasperations in Chronic Obstructive Pulmonary Disease

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Data from the Phase III MATINEE clinical trial demonstrated that GSK’s Nucala (mepolizumab) produced a statistically significant and clinically meaningful reduction in moderate and severe exacerbations in patients with chronic obstructive pulmonary disease (COPD). MATINEE is a part of GSK’s Nucala program in COPD, which is comprised of three clinical trials.

The first two studies, METREX and METREO, were completed in 2017, whereas the third trial, MATINEE was launched to supplement the findings of the previous two trials. Investigators employed interleukin (IL)-5 science to identify the patients who could benefit the most from Nucala and support future submissions and approvals for use in this indication.

The multi-center, randomized, placebo controlled, double-blind, parallel group MATINEE study was designed to confirm the benefits of Nucala treatment on moderate or severe exacerbations in 806 participants with COPD. Patients enrolled in the trial had chronic bronchitis and/or emphysema, were on optimized inhaled maintenance therapy, and exhibited type 2 inflammation with elevated blood eosinophil counts. As part of the trial, patients were randomly assigned to receive either Nucala or a placebo as an add on to their optimized maintenance COPD therapy for at least 52 weeks and up to a maximum of 104 weeks.¹

First approved in 2015, Nucala, is a monoclonal antibody that targets IL-5. It was previously approved to treat eosinophilic asthma in patients over the age of six years, severe chronic rhinosinusitis with nasal polyps, eosinophilic granulomatosis with polyangiitis, and hypereosinophilic syndrome. According to the European Medicines Agency, the treatment administered via injection under the skin of the upper arm, thigh or abdomen every four weeks. Nucala works by attaching itself to IL-5, a key protein in type 2 inflammation. By attaching itself to the protein, Nucala blocks its action and effectively reduces inflammation.^1,2

GSK states that COPD is the third leading cause of death worldwide with exacerbations accounting for the greatest proportion of the total COPD burden on the healthcare system. Further, patients with COPD tend to have chronic inflammation, leading to persistent respiratory symptoms, such as breathlessness and a productive cough.¹

Statistics from the World Health Organization (WHO) show that in 2019, COPD resulted in 3.23 million deaths, with close to 90% occurring in individuals under 70 years of age and in low- and middle-income countries. In high income countries, 70% of COPD cases come from a history of smoking tobacco, while it also accounts for 30%–40% of COPD cases in low- and middle-income countries. WHO also stated that household air pollution poses a serious risk for COPD.³

According to COPD.net, men were previously more likely to develop COPD during their lifetime due to the likelihood of being in careers that exposed them to toxic irritants while also smoking much more than women. In more recent years, statistics have found that women are slightly more likely to develop COPD, who comprise 56% of individuals with COPD. It is currently unknown why there has been a significant shift in these numbers.⁴

GSK expects that findings from the MATINEE trial will affect a global COPD population of over 300 million people and inform ongoing regulatory discussions. The company plans on presenting full data from MATINEE at a future scientific congress. Currently, Nucala is not yet approved for COPD by any regulatory authority.¹

References

1. GSK announces positive results from phase III trial of Nucala (mepolizumab) in COPD. GSK. September 6, 2024. Accessed September 6, 2024. https://www.gsk.com/en-gb/media/press-releases/gsk-announces-positive-results-from-phase-iii-trial-of-nucala-mepolizumab-in-copd/

2. Nucala. EMA. Accessed September 6, 2024. https://www.ema.europa.eu/en/medicines/human/EPAR/nucala

3. Chronic obstructive pulmonary disease (COPD). WHO. March 16, 2023. Accessed September 6, 2024. https://www.who.int/news-room/fact-sheets/detail/chronic-obstructive-pulmonary-disease-(copd)

4. Statistics. COPD.net. March 31, 2015. Accessed September 6, 2024. https://copd.net/statistics