GSK and Theravance announce results from the SUMMIT COPD CV Survival Study

September 11, 2015

LONDON, UK - September 11, 2015 - GlaxoSmithKline and Theravance, Inc. announced initial results from the Study to Understand Mortality and MorbidITy in COPD (SUMMIT) for Relvar®/Breo® Ellipta®. The study involved 16,485 patients from 43 countries who had chronic obstructive pulmonary disease (COPD) with moderate airflow limitation and either a history or increased risk of cardiovascular disease (CVD). The Study to Understand Mortality and MorbidITy (SUMMIT) in COPD is the first prospective study that aimed to understand the effect of respiratory treatments in patients with COPD and a history or risk of CVD.

Results demonstrated that while Breo Ellipta reduced the risk of all-cause mortality by 12.2 percent versus placebo, the difference was not statistically significant over the study period. Although the therapy reduced the rate of lung function decline by 8 millilitres per year compared to placebo, the companies said statistical significance could not be determined because Breo Ellipta failed to meet its primary endpoint. The drug was associated with a 7.4 percent lower risk of an on-treatment cardiovascular event versus placebo, which also was not a significant difference.

Eric Dube, head of GlaxoSmithKline's global respiratory franchise, stated that, "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." He added that Breo Ellipta "continues to play an important role in the treatment of appropriate patients with COPD." The companies indicated that the results will be the subject of future publications and presentations, including at the European Respiratory Society (ERS) meeting in September.