Shares in Theravance have taken a beating after the firm and partner GlaxoSmithKline’s Breo Ellipta (fluticasone/vilanterol) failed to hit its key survival target in the SUMMIT trial.
The drugmakers were assessing whether the therapy lowered the risk of death versus placebo in chronic obstructive pulmonary disease patients who also have a history of or are at higher risk from cardiovascular disease.
But data from SUMMIT showed that, while the risk of all-cause mortality was 12.2% lower in the treatment arm, this difference was not statistically significant, pushing Theravance’s stock down as much as 17%.
In a further blow, although BREO Ellipta pulled back the rate of lung function decline by 8 millilitres per year versus placebo, the firms said statistical significance cannot be inferred because the primary endpoint wasn’t met. The treatment also failed on the second secondary endpoint of significantly lowering the risk of an on-treatment cardiovascular event versus placebo.
The trial was the first to examine the inhaler’s effect on survival in this co-morbid patient population.
“While the study was unable to demonstrate a statistically significant improvement on this endpoint, it provides us with a wealth of data to help us as clinicians understand the interplay between these two conditions and insights on how to improve the management of these patients,” said lead investigator, Jørgen Vestbo, Professor of Respiratory Medicine at the Centre for Respiratory Medicine and Allergy, University Hospital South Manchester NHS Foundation Trust and the University of Manchester.
Breo Ellipta was first cleared in the US in 2013 as a long-term, once-daily maintenance treatment of airflow obstruction in patients COPD, and later that year in Europe, as Relvar Ellipta, for the treatment of asthma and COPD.