GlaxoSmithKline (GSK) and Theravance have announced initial results from the SUMMIT COPD study for Relvar/Breo Ellipta (fluticasone furoate/vilanterol or FF/VI) 100/25mcg.
The study involved 16,485 patients from 43 countries who had chronic obstructive pulmonary disease (COPD) with moderate airflow limitation (FEV1 50-70% predicted) and either a history or increased risk of cardiovascular disease (CVD).
For the primary endpoint of the study, the risk of dying on FF/VI 100/25mcg was 12.2% lower than on placebo over the study period, which was not statistically significant.
For the first of two secondary endpoints, FF/VI 100/25mcg reduced the rate of lung function decline by 8mL per year compared with placebo. As the primary endpoint was not met, statistical significance cannot be inferred from this result. For the other secondary endpoint, the risk of experiencing an on-treatment cardiovascular event at any time was 7.4% lower in patients taking FF/VI 100/25mcg versus placebo which was not statistically significant.
The study also formally analysed a number of additional COPD endpoints assessing the efficacy of FF/VI relative to placebo, which included FEV1, rate of moderate/severe exacerbations, time to first moderate/severe exacerbation, time to first severe exacerbation, rate of severe exacerbation, health related quality of life and health status as measured using the COPD Assessment Tool at 12 months. Against these endpoints FF/VI demonstrated an improvement compared to placebo. As the primary endpoint was not met, statistical significance cannot be inferred from these results.
Full data set still beneficial and informative to the respiratory and cardiovascular scientific community
The results will be the subject of future publications and presentations, including at the European Respiratory Society (ERS) International Congress in September.
Eric Dube, SVP and Head, Global Respiratory Franchise, GSK said, “SUMMIT is an important study as this is the first time that survival has been studied in this under-researched co-morbid patient population. While we didn’t achieve statistical significance on the primary endpoint, we believe the full data set will be beneficial and informative to the respiratory and cardiovascular scientific community. Relvar/Breo 100/25mcg continues to play an important role in the treatment of appropriate patients with COPD and as leaders in respiratory, GSK remains committed to tackling the major challenges that physicians and patients face in the treatment of respiratory disease.”
