GSK preparing submissions for Nucala in COPD

GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) plans to submit regulatory applications this half for Nucala mepolizumab (SB-240563) to treat chronic obstructive pulmonary disease (COPD) with an eosinophilic phenotype after reporting mixed data from the double-blind, international Phase III METREX and METREO trials. The trials enrolled COPD patients at high risk of exacerbations despite the use of optimal standard of care (SOC) background therapy consisting of an inhaled corticosteroid (ICS), long-acting adrenergic receptor beta 2 agonist (LABA) and long-acting muscarinic receptor antagonist (LAMA).

In the 836-patient METREX (Study 117106) trial, 100 mg subcutaneous mepolizumab every 4 weeks met the primary endpoint of reducing the mean annual rate of moderate or severe exacerbations in patients with a blood eosinophil count of >150 cells/µL at study entry or >300 cells/µL within the past year (n=462) vs. placebo (1.4 vs. 1.71 exacerbations per year, p=0.036). Mepolizumab also met the secondary endpoint of increasing the time to first moderate and severe exacerbation vs. placebo (192 vs. 141 days, p=0.04), but missed the secondary endpoints of reducing the annual rate of exacerbations requiring hospitalization, St. George’s Respiratory Questionnaire (SGRQ) score and COPD assessment score vs. placebo...