GlaxoSmithKline and Innoviva reported Wednesday that a late-stage study of Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) in patients with chronic obstructive pulmonary disease (COPD) met its primary endpoint, demonstrating significant reductions in the annual rate of on-treatment moderate/severe exacerbations compared to Relvar/Breo Ellipta (fluticasone furoate/vilanterol) and Anoro Ellipta (umeclidinium/vilanterol).
In the IMPACT study, 10 355 patients with moderate to very severe symptomatic COPD were randomised to treatment with Trelegy Ellipta, Relvar/Breo Ellipta or Anoro Ellipta over 52 weeks. In addition to the primary goal, other assessed endpoints included lung function and patient reported outcomes, such as health-related quality of life measures.
Head-line results from the trial showed that Trelegy Ellipta led to a 15-percent reduction in the annual rate of on-treatment moderate/severe exacerbations versus Relvar/Breo Ellipta and a 25-percent reduction compared to Anoro Ellipta. GlaxoSmithKline and Innoviva noted that Trelegy Ellipta was also associated with significant improvements across all key secondary endpoints. Specifically, the change from baseline trough forced expiratory volume in one second for the triple therapy was 97 ml versus Relvar/Breo Ellipta and 54 ml compared to Anoro Ellipta.
In addition, change from baseline in the St George's Respiratory Questionnaire score at week 52 was -1.8 units for Trelegy Ellipta versus both dual therapies. Trelegy Ellipta was also associated with reductions of 14.8 percent and 16 percent in the time to first on-treatment moderate/severe COPD exacerbation compared to Relvar/Breo Ellipta and Anoro Ellipta, respectively. GlaxoSmithKline and Innoviva indicated that data from the study will be presented at future research conferences and submitted for publication in peer-reviewed journals.
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Patrick Vallance, president of R&D at GlaxoSmithKline, said "this is the first study to report a comparison of a single inhaler triple therapy with two dual therapies, providing much needed clinical evidence about the ability of a single inhaler triple therapy to reduce exacerbations." Vallance added "it is important to note that all treatments were comprised of different combinations of the same component molecules administered in the same Ellipta inhaler, in a single dose, once a day, to allow direct treatment comparisons."
Trelegy Ellipta was cleared this week in the US for the treatment of certain patients with COPD, including chronic bronchitis or emphysema. Meanwhile, the European Medicines Agency's Committee for Medicinal Products for Human Use recently backed approval of the drug for use in patients with COPD that is not adequately controlled by the combination of an inhaled corticosteroid and a long-acting beta2-agonist. The companies also plan to pursue global regulatory filings based on data from the IMPACT trial beginning in the second quarter of next year to expand Trelegy Ellipta's indicated patient population.
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