GlaxoSmithKline: SUMMIT COPD CV Survival Study Fails To Meet Primary Point

(RTTNews) - GlaxoSmithKline plc (GSK, GSK.L) and Theravance Inc (THRX) on Tuesday announced initial results from the Study to Understand Mortality and MorbidITy in COPD (SUMMIT) for Relvar/Breo Ellipta 100/25mcg (fluticasone furoate 'FF'/vilanterol 'VI' or 'FF/VI').

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).

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 (as measured by forced expiratory volume in one second, 'FEV1') 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 (CV) event (CV death, myocardial infarction, stroke, unstable angina and transient ischemic attack at any time was 7.4% lower in patients taking FF/VI 100/25mcg versus placebo which was not statistically significant.