GlaxoSmithKline reported positive results from the pioneering Salford Lung Study (SLS) evaluating Relvar Ellipta 100/25 mcg for the treatment of exacerbations in patients with chronic obstructive pulmonary disease (COPD). Relvar is a combination of the inhaled corticosteroid (ICS), fluticasone furoate “FF,” and the long-acting beta2-agonist (LABA), vilanterol “VI” (FF/VI).
The results from the primary efficacy analysis of the Phase 3b multi-center, open-label study demonstrated that compared to usual care, treatment with Relvar Ellipta 100/25mcg reached a superior reduction in COPD exacerbations (8.41 percent). Usual care included inhaled monotherapy with corticosteroids (ICS), long-acting muscarinic antagonists (LAMA), long-acting beta2-agonists (LABA), or dual or triple combined treatment regimens.
In terms of incidence of serious adverse events (SAE) within the intent-to-treat (ITT) patient’s groups, the observed SAEs were similar between the study arms (29 percent FF/VI, 27 percent usual care). Of particular clinical relevance, in pneumonia, treatment with FF/VI was found to be non-inferior to usual care (7 percent vs. 6 percent, respectively).
This study endpoint was a regulatory post-authorization measure that the European Medicines Agency (EMA) had requested.
“In this genuinely groundbreaking study we have worked closely with the local NHS clinical community to study patients in their everyday setting,” said Patrick Vallance, president of pharmaceuticals research and development at GSK, in a recent press release. “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, senior vice president and head of Global Respiratory Franchise at 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,” Dube 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, said the Salford Lung Study is an important trial to help us understand more about the medicines prescribed on a daily basis.
“This is an important finding; what we are seeing today is the tip of the iceberg,” Vestbo said. “Over the coming months we will understand more about the day-to-day effectiveness of FF/VI and how treatment choice, patient behavior, 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 CEO of Innoviva, said the company is 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,” Aguiar said. “The data is 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.”
The company added that it is continuing to conduct clinical assessments, and the results will soon be reported in future publications and presentations. A second Salford Lung Study is ongoing in patients with asthma, with GlaxoSmithKline expecting to report results next year.