GlaxoSmithKline plc and Innoviva, Inc. have announced positive headline results from the innovative Salford Lung Study (SLS) in Chronic Obstructive Pulmonary Disease (COPD). The study showed that Relvar® Ellipta® 100/25mcg (fluticasone furoate ‘FF’/vilanterol ‘VI’ or ‘FF/VI’) achieved a superior reduction in exacerbations versus usual care, in patients with COPD, in an everyday clinical practice setting. Usual care included long-acting muscarinic antagonists (LAMA), long-acting beta2-agonists (LABA), and inhaled corticosteroids (ICS) administered as monotherapy, dual or triple combinations.
For the primary effectiveness analysis, in patients treated with FF/VI 100/25mcg there was a statistically significant reduction of 8.41% (CI 1.12,15.17) in the rate of moderate or severe exacerbations compared with those receiving usual care (p=0.025).
Within the intent-to-treat (ITT) population, the incidence of serious adverse events (SAE) was similar between the groups (29% FF/VI, 27% usual care). For pneumonia, an SAE of special interest, FF/VI demonstrated non-inferiority versus usual care (7% FF/VI versus 6% usual care). This endpoint was a regulatory post-authorisation measure requested by the European Medicines Agency (EMA).
Patrick Vallance, President, Pharmaceuticals R&D, GSK, commented: “In this genuinely ground-breaking study we have worked closely with the local NHS clinical community to study patients in their everyday setting. To ensure the results from Salford were as robust as possible, we made a long-term financial investment in the study, including supporting local infrastructure and training. Innovation often means you have to ask challenging questions to make significant advances, and I believe this is what we have achieved in these positive results announced today.”
Eric Dube, SVP and Head, Global Respiratory Franchise, GSK, said: “The Salford Lung Study COPD results support the effectiveness of Relvar. As we move beyond the headline results, we will learn so much more about the medicine and disease management. We believe the results could transform understanding of how patients in everyday clinical practice respond to COPD treatments. We want to say a big thank you to everyone who has made this unique study possible.”
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, said: “The Salford Lung Study is a very important trial to help us understand more about the medicines we prescribe on a day-to-day basis. This is an important finding; what we are seeing today is the tip of the iceberg. Over the coming months we will understand more about the day-to-day effectiveness of FF/VI and how treatment choice, patient behaviour, co-morbidities and other factors combine to influence COPD outcomes. This has been a highly collaborative effort to gather data that will help improve understanding about the effectiveness of respiratory medicines when used in usual clinical practice.”
Michael W. Aguiar, President and Chief Executive Officer of Innoviva., said: “We are very pleased that Relvar Ellipta achieved superiority compared to usual care in SLS, a world-first effectiveness study in COPD. These data provide a significant body of evidence in everyday clinical practice and add to the data generated from other randomized controlled studies. These data are unique in the world of evidence generation in COPD. We look forward to disclosing further data and analyses, which we believe will be of significant value to both physicians and patients.”
Analyses remain ongoing and will be the subject of future publications and presentations. A second Salford Lung Study is currently being conducted in asthma patients, with results expected in 2017.