GSK's Trelegy Ellipta meets in Phase III IMPACT trial for COPD
GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) and Innoviva Inc. (NASDAQ:INVA) reported data from the Phase III IMPACT trial in 10,355 chronic obstructive pulmonary disease (COPD) patients showing that once-daily Trelegy Ellipta fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) met the primary endpoint of reducing the annual rate of on-treatment moderate and severe exacerbations compared to both fluticasone furoate/vilanterol (0.91 vs. 1.07 exacerbations per year, p<0.001) and umeclidinium bromide/vilanterol (0.91 vs. 1.21 exacerbations per year, p<0.001). The double-blind, international trial enrolled patients with moderate to very severe symptomatic COPD and a history of exacerbation in the previous 12 months.
Trelegy Ellipta also met the secondary endpoints of improving trough forced expiratory volume in 1 second (FEV1) from baseline to week 52, St. George’s Respiratory Questionnaire (SGRQ) score and time to first on-treatment moderate or severe exacerbation compared to both fluticasone furoate/vilanterol and umeclidinium bromide/vilanterol (p<0.001 for all)...