Preliminary results from phase III trial of Nucala (mepolizumab) in chronic obstructive pulmonary disease- GlaxoSmithKline

GlaxoSmithKline has announced preliminary results of two pivotal phase III studies evaluating the efficacy and safety of Nucala (mepolizumab), as an investigational add on treatment for adults who have chronic obstructive pulmonary disease (COPD) with an eosinophilic phenotype. The primary objective of the 52-week treatment studies was to investigate whether reducing eosinophils (a type of white blood cell) with subcutaneous mepolizumab 100mg and 300mg would decrease the frequency of moderate and severe exacerbations in COPD patients at high risk of exacerbations despite use of optimal standard of care therapy.

Study 117106 (METREX) randomised 836 patients to mepolizumab 100mg or placebo across two groups according to blood eosinophil count. In the group with higher eosinophils, there was a statistically significant reduction in the frequency of moderate and severe exacerbations for mepolizumab 100mg compared to placebo (18%, p=0.036 after multiplicity adjustment). Study 117113 (METREO) randomised 674 patients to mepolizumab 100mg, mepolizumab 300mg or placebo. A reduction in the frequency of moderate and severe exacerbations for mepolizumab compared to placebo was seen which was not statistically significant (20% for 100mg, p=0.068; 14% for 300mg, p=0.140 after multiplicity adjustment). No safety concerns were identified on review of headline data from these studies. Full results will be submitted for presentation at an upcoming scientific congress and for publication in a peer-reviewed journal.