GSK suffers Breo late-stage trial blow
pharmafile | September 9, 2015 | News story | Research and Development | COPD, GSK, Revlar, asthma, breo, clinical trial, phase III
GSK has hit a setback in its plans to expand sales of its blockbuster asthma treatment Breo, after a major study found it failed to improve survival in people with COPD.
It had been banking on positive results from the SUMMIT study to support future regulatory applications for its respiratory drug Breo (a combination of fluticasone furoate and vilanterol trifenatate, called Revlar in the UK), as a treatment for the lung disease chronic obstructive pulmonary disease (COPD). GSK co-markets the drug with US firm Theravance Biopharma,
The Phase III study involved 16,485 patients from 43 countries who had a moderate form of COPD and either a history of or increased risk of cardiovascular disease (CVD).
The primary endpoint of the study, the risk of premature death from any cause, was 12.2% lower in people treated with Breo than people on a placebo over the four-year study period. This difference was not statistically significant.
Treatment with Breo did improve the rate of decline in lung function, one of the trial’s secondary endpoints, however as the trial failed to reach its primary endpoint researchers cannot be certain if this is clinically meaningful. People treated with Breo had a 7.4% lower risk of dying from cardiovascular disease, or having a heart attack, stroke or mini-stroke, or unstable angina, but again this was not statistically significant.
Eric Dube, who is senior vice president and head of GSK’s global respiratory franchise, insisted the full results will show Breo could be an option for people with COPD.
“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.”
Lead investigator Jørgen Vestbo, professor of respiratory medicine at the centre for respiratory medicine and allergy, at the University Hospital South Manchester NHS Foundation Trust and the University of Manchester, says: “We have long known that CVD often coexists with COPD and that each disease is a leading cause of death globally. The SUMMIT study is the first prospective study to investigate the interaction between these two diseases and set out to achieve the ambitious goal of demonstrating a reduction in death from any cause in patients with both COPD and CVD.
“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.”
Lilian Anekwe
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