Phase III IMPACT study of Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) meets primary endpoint in chronic obstructive pulmonary disease.- GlaxoSmithKline + Innoviva.

GlaxoSmithKline and Innoviva announced positive headline results from the landmark phase III IMPACT study of Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol, FF/UMEC/VI) for patients with chronic obstructive pulmonary disease (COPD) who are receiving Breo (fluticasone furoate/vilanterol, FF/ VI) and require additional bronchodilation or who are receiving Breo and Incruse (umeclidinium, UMEC).

The IMPACT study, which involved 10,355 patients, met its primary endpoint demonstrating statistically significant reductions in the annual rate of on-treatment moderate/severe exacerbations for FF/UMEC/VI (100/62.5/25mcg) when compared with two, once-daily dual COPD therapies from GSK’s existing portfolio. The study showed a 15% reduction for FF/UMEC/VI compared with Relvar/Breo Ellipta (FF/VI,100/25mcg); 0.91 vs 1.07 per year; a 25% reduction for FF/UMEC/VI compared with Anoro Ellipta (UMEC/VI, 62.5/25mcg);and 0.91 vs 1.21 per year.

In addition, statistically significant improvements were observed across all pre-specified key secondary endpoints and associated treatment comparisons. This included a change from baseline trough FEV1 at week 52 for FF/UMEC/VI compared with FF/VI was 97mL; and for FF/UMEC/VI compared with UMEC/VI was 54mL, and a change from baseline St George’s Respiratory Questionnaire at week 52 for FF/UMEC/VI compared with FF/VI was -1.8 units; and for FF/UMEC/VI compared with UMEC/VI was -1.8 units. Analysis of time to first on-treatment moderate/severe COPD exacerbation demonstrated a 14.8% reduction in risk for FF/UMEC/VI compared with FF/VI and a 16.0% reduction in risk for FF/UMEC/VI compared with UMEC/VI.

Based on review of the headline data, the safety profile of FF/UMEC/VI was consistent with the known profile of the individual medicines and their dual combinations.