GSK says Nucala delivers clinically meaningful reduction in COPD exacerbations

The company states: “GSK (GSK) plc announced positive results for Nucala, or mepolizumab, in the treatment of chronic obstructive pulmonary disease, COPD, with the full results from the MATINEE phase III trial published in the New England Journal of Medicine. The trial evaluated mepolizumab, a monoclonal antibody targeting interleukin-5, in a wide spectrum of patients with COPD, including the most severe and difficult to treat as categorised in the Global Initiative for Chronic Obstructive Lung Disease guidelines. Patients recruited had evidence of type 2 inflammation, characterised by blood eosinophil count, and included those with chronic bronchitis, emphysema-only or both. The monthly administration of mepolizumab demonstrated improvement across all exacerbation endpoints, which were maintained over the 2-year study period. In the full population studied, mepolizumab showed a clinically meaningful and statistically significant 21% reduction in the annualised rate of moderate/severe exacerbations versus placebo, meeting the primary endpoint for MATINEE. In addition, mepolizumab also showed a 31% reduction in the annualised rate of moderate/severe exacerbations versus placebo in a post-hoc analysis of patients with clinician assessed chronic bronchitis only. A 35% reduction in the annualised rate of exacerbations leading to emergency department visits and/or hospitalisation was shown with mepolizumab versus placebo, a secondary endpoint of the MATINEE study. Mepolizumab is the only biologic with data that shows a reduction in emergency department visits and/or hospitalisation in a phase III trial. Reducing hospitalisations is a key goal of COPD management. COPD-related hospitalisations are a major healthcare challenge and projected to become the number one cause of medical admissions. If hospitalised due to COPD, one in ten patients will die during the stay, up to one in four over the next year and half will lose their lives within five years.”