GSK and Theravance’s SUMMIT COPD CV Survival Study Fails to Achieve Primary Endpoint

GSK and Theravance’s SUMMIT COPD CV Survival Study Fails to Achieve Primary Endpoint

GlaxoSmithKline and Theravance, Inc. have announced results from the Study to Understand Mortality and MorbidITy (SUMMIT) in chronic obstructive pulmonary disease (COPD). This was a Phase 3 clinical trial of the Relvar®/Breo® Ellipta® combination treatment. A total of 16,485 individuals with COPD and cardiovascular disease history or risk from 43 countries participated in the study. A Phase 3 trial is the final step before drug approval.

The main outcome (primary endpoint) for the study was risk of death, which was 12.2% lower with the treatment than with placebo. Unfortunately, the effect was not strong enough according to scientific standards, since it was not statistically significant. The treatment did reduce the rate of lung function decline compared with placebo, which was considered a secondary endpoint.

Another secondary endpoint, the risk of experiencing cardiovascular events, (including death, myocardial infarction, stroke, unstable angina and transient ischemic attack) was not reduced in the treatment group compared to the placebo group to a degree that reached statistical significance.

The treatment resulted in improvements in several other measurements of COPD severity, but because the study did not meet the primary endpoint, researchers do not consider the results to be as substantial, despite the fact that they reached statistical significance.

Study participants experienced a similar incidence of side effects in the group receiving the medication compared to the group that received a placebo.

Eric Dube, SVP and Head, Global Respiratory Franchise, GSK remarked: “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.”

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, added: “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.”

Michael W. Aguiar, President and Chief Executive Officer of Theravance, Inc., additionally noted: “While we were unable to demonstrate a statistically significant survival benefit in this population, the full data set from SUMMIT, the largest study with Relvar/Breo conducted to date, provides additional confidence in the safety and efficacy of Relvar/Breo 100/25mcg as a once-a-day treatment to improve lung function and reduce exacerbation risk in patients with COPD.”

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