GlaxoSmithKline, alongside Nasdaq-listed partner Innoviva, announced the publication of the landmark IMPACT study – one of the biggest ever conducted in patients with chronic obstructive pulmonary disease with a history of exacerbation – in the New England Journal of Medicine on Thursday.
The FTSE 100 pharmaceutical giant said that n the study, 'Trelegy Ellipta' (fluticasone furoate/umeclidinium/vilanterol) achieved superiority to members of two different classes of dual combination therapy, Relvar/Breo and Anoro, on the primary endpoint of reduction in the annual rate of on-treatment moderate/severe exacerbations and a range of other clinically important outcomes, including lung function and health-related quality of life.

It said results from additional secondary and other endpoints included a “statistically significant” 34% reduction in COPD hospitalisations for Trelegy compared to Anoro, and a reduction of 13% compared to Relvar/Breo, which was not statistically significant.

They also included a “significant” reduction in the risk of on-treatment all-cause mortality, observed for both inhaled corticosteroid containing arms compared to Anoro.

A 42.1% reduction in the risk of on-treatment all-cause mortality was observed for Trelegy compared to Anoro as well.

To fully understand the implications of the all-cause mortality observation, off-treatment data also needed to be considered, GSK explained.

Work was ongoing to investigate that further, and would be presented at future scientific meetings.

“Reducing exacerbations to keep patients out of hospital is a key goal of COPD management alongside improving lung function and quality of life,” said Dave Allen, GSK's head of respiratory therapy area research and development.

“The IMPACT study shows how Trelegy Ellipta can help patients with a history of exacerbation achieve these goals.

“We believe its publication in NEJM is an important addition to the evidence base that informs the management of this progressive and debilitating disease.”

Dr Fernando Martinez, chief of the division of pulmonary and critical care medicine at the New York-Presbyterian Hospital/Weill Cornell Medical Center, said IMPACT “significantly advances” medicine's understanding of COPD management by addressing a number of key evidence gaps.

“By comparing various combinations of effective medications in the same device the study clarifies which type of patient gains greatest benefit from each class of medicine,” Dr Martinez explained.

“As many patients experience frequent exacerbations or 'flare ups', which can often result in hospitalisation, these data will be highly relevant to patients and clinicians as they consider the optimal treatment.”

GSK and Innoviva said the safety profile of single inhaler triple therapy was consistent with the safety profile of the individual components.

The most common adverse events across the treatment groups were viral upper respiratory tract infection, worsening of COPD, upper respiratory tract infection, pneumonia and headache.

Consistent with previous studies, the incidence of pneumonia as a serious adverse event was 4%, 4%, and 3% for FF/UMEC/VI, FF/VI and UMEC/VI, respectively.

“The role of inhaled corticosteroids in COPD have long been debated, and this landmark trial provides further evidence of their benefit in the population studied and compelling data towards clarifying the role of ICS containing regimens in the COPD treatment paradigm,” said Dr Ted Witek, Innoviva's senior vice president and chief scientific officer.

“We congratulate our partners at GSK for this vital contribution to the field of respiratory medicine.”

Results from IMPACT were submitted to the regulatory authorities in the US and EU in November 2017 and February this year, respectively.

Further regulatory submissions in other countries were expected during 2018.