GlaxoSmithKline and Innoviva, Inc announced that GlaxoSmithKline plc (GSK) presented new data at the American Thoracic Society (ATS) Conference from two pre-specified analyses from the Study to Understand Mortality and MorbidITy (SUMMIT) trial. One demonstrated that patients with Chronic Obstructive Pulmonary Disease (COPD) and moderate airflow limitation receiving Breo® Ellipta® (fluticasone furoate/vilanterol or FF/VI 100/25mcg) achieved improvements in exacerbations compared with placebo.
The second analysis demonstrated these patients reported similar rates of pneumonia when taking FF/VI 100/25mcg compared with placebo.
The SUMMIT trial was designed to evaluate the effect of FF/VI 100/25mcg once-daily on all-cause mortality compared with placebo in patients with moderate COPD who had, or were at high risk for Cardiovascular Disease (CVD). Results of the primary endpoint were announced in 2015 and showed that all cause mortality was not affected by combination therapy or the individual components.
The first analysis presented investigated the impact of FF/VI 100/25mcg, an inhaled corticosteroid/long-acting beta2 agonist combination (ICS/LABA), on exacerbations in COPD patients with moderate airflow limitation (mean FEV1 60% predicted). In patients treated with FF/VI 100/25mcg the risk of a COPD exacerbation, measured by time to first exacerbation, was decreased by 20% (HR 0.80, 95% confidence interval 0.73 – 0.86) versus placebo. In addition, FF/VI 100/25mcg led to a 29% reduction in the rate of a moderate to severe exacerbation of COPD compared with placebo.
A second analysis of all reported pneumonia events amongst the 16,568 patients in the SUMMIT trial showed that rates were similar for patients randomised to FF/VI 100/25mcg compared with those on placebo. Reported pneumonia related adverse-events on FF/VI 100/25mcg were 6% compared with placebo 5%, reported pneumonia related serious adverse-events on FF/VI 100/25mcg were 3% compared with placebo 3%.
Dr Courtney Crim, Director Clinical Development, R&D Respiratory, GSK said that we believe these data are important for COPD physicians and are clinically relevant. These findings from SUMMIT show that COPD patients with moderate airflow limitation experienced both a lower risk of having an exacerbation and fewer exacerbations when treated with FF/VI than patients on placebo. In the same patients with moderate airflow limitation we also saw a similar incidence of pneumonia in patients on FF/VI and those on placebo. In previous studies, in more severe patients, an increase in the incidence of pneumonias has been observed in ICS-containing treatment arms. The finding from this study is therefore interesting and will require further investigation.”
These data were presented at the ATS 2016 Conference 13 – 18 May, San Francisco, US:
F.J. Martinez, et al. The impact of vilanterol, fluticasone furoate, or their combination on exacerbations in COPD patients with moderate airflow obstruction: the SUMMIT trial. D36-COPD: LABA, LAMA, ICS, AND COMBINATIONS, Thematic Poster Session. Wednesday, May 18, 2016. 9:00 AM-3:30 PM
C. Crim, et al. Reported Pneumonia Events in the SUMMIT trial. B44-COPD: COMORBIDITIES. Thematic Poster Session. Monday May 16, 2016. 9:00 AM-4:15 PM
About COPD and CVD
Chronic Obstructive Pulmonary Disease (COPD) is a disease of the lungs that includes chronic bronchitis, emphysema or both. COPD is characterised by obstruction to airflow that interferes with normal breathing. Cigarette smoke, breathing in second-hand smoke, air pollution including biomass fuels, chemical fumes and dust from the environment or workplace can all contribute to COPD.
COPD mortality is increasing and is the third leading cause of death globally. COPD often coexists with other chronic diseases and epidemiological data suggests that CVD or CV risk occurs in nearly half of all patients with COPD.CVD is the number one killer of mild to moderate COPD patients and patients with both COPD and CVD or CV risk were observed to have a mortality rate double that of COPD patients without CVD in studies of up to 15 years in duration.
About FF/VI 100/25mcg
FF/VI 100/25mcg, under the brand name Breo® Ellipta® 100/25mcg is licensed in the US for:
• the long-term, once-daily, maintenance treatment of airflow obstruction in patients with Chronic Obstructive Pulmonary Disease (COPD), including chronic bronchitis and/or emphysema and to reduce exacerbations of COPD in patients with a history of exacerbations. Breo® Ellipta®100/25mcg is the only strength indicated for the treatment of COPD.
• Breo Ellipta100/25mcg is not indicated for the relief of acute bronchospasm.
Full US prescribing information, including BOXED WARNING and Medication Guide is available at us.gsk.com or US Prescribing Information Breo Ellipta.
FF/VI 100/25mcg, under the brand name Relvar® Ellipta® is approved in Europe for:
• the symptomatic treatment of adults with chronic obstructive pulmonary disease (COPD) with a FEV1<70% predicted normal (post-bronchodilator) with an exacerbation history despite regular bronchodilator therapy.
For the EU Summary of Product Characteristics for Relvar Ellipta, please visit: http://ec.europa.eu/health/documents/community-register/html/h886.htm
About GSK
One of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com.
About Innoviva
Innoviva is focused on bringing compelling new medicines to patients in areas of unmet need by leveraging its significant expertise in the development, commercialization and financial management of bio-pharmaceuticals. Innoviva’s portfolio is anchored by the respiratory assets partnered with Glaxo Group Limited (GSK), including RELVAR®/BREO® ELLIPTA® and ANORO® ELLIPTA®, which were jointly developed by Innoviva and GSK. Under the agreement with GSK, Innoviva is eligible to receive associated royalty revenues from RELVAR®/BREO® ELLIPTA®, ANORO® ELLIPTA® and, if approved and commercialized, VI monotherapy, as well. In addition, Innoviva retains a 15 percent economic interest in future payments made by GSK for earlier-stage programs partnered with Theravance BioPharma, Inc. For more information, please visit Innoviva’s website at www.inva.com, RELVAR®, BREO®, ANORO® and ELLIPTA® are trademarks of the GlaxoSmithKline group of companies.
