GlaxoSmithKline posts positive results from Trelegy Ellipta study

GlaxoSmithKline’s positivity around its Trelegy Ellipta product continued on Wednesday, as the company - alongside US firm Innoviva - announced headline results from the landmark phase III IMPACT study.

The FTSE 100 drugmaker described Trelegy Ellipta as the first and only FDA-approved once-daily single inhaler triple therapy comprising an inhaled corticosteroid (ICS), long-acting muscarinic antagonist (LAMA) and long-acting beta agonist (LABA).

It said the product, containing fluticasone furoate/umeclidinium/vilanterol, was approved for the long-term, once-daily, maintenance treatment of patients with chronic obstructive pulmonary disease (COPD) who were receiving Breo (fluticasone furoate/vilanterol, FF/ VI) and required additional bronchodilation, or who were receiving Breo and Incruse (umeclidinium, UMEC).

“We are delighted with the positive results achieved in the IMPACT study,” said GlaxoSmithKline’s president of research and development.

“This is the first study to report a comparison of a single inhaler triple therapy with two dual therapies, providing much needed clinical evidence about the ability of a single inhaler triple therapy to reduce exacerbations.”

The IMPACT study, which involved 10,355 patients, met its primary endpoint demonstrating “statistically significant reductions” in the annual rate of on-treatment moderate/severe exacerbations for FF/UMEC/VI (100/62.5/25mcg) when compared with two, once-daily dual COPD therapies from GSK's existing portfolio, the company’s board said.

It showed a 15% reduction for FF/UMEC/VI compared with Relvar/Breo Ellipta (FF/VI,100/25mcg), and a 25% reduction for FF/UMEC/VI compared with Anoro Ellipta (UMEC/VI, 62.5/25mcg).

In addition, “statistically significant” improvements were observed across all prespecified key secondary endpoints and associated treatment comparisons.

Based on review of the headline data, the safety profile of FF/UMEC/VI was consistent with the known profile of the individual medicines and their dual combinations, GSK said.

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.

GSK said the incidences of the most frequent serious adverse events were worsening of COPD: 11%, 11% and 13% for FF/UMEC/VI, FF/VI and UMEC/VI, respectively; and pneumonia: 4%, 4% and 3% for FF/UMEC/VI, FF/VI and UMEC/VI, respectively.

“It is important to note that all treatments were comprised of different combinations of the same component molecules administered in the same Ellipta inhaler, in a single dose, once a day to allow direct treatment comparisons,” added Patrick Vallance.

“We hope these results will inform global guidelines and look forward to sharing the results with regulatory authorities.

“We will continue to analyse the wealth of data generated to further the understanding of the treatment of COPD.”

Mike Aguiar, CEO of Innoviva, said the results of the IMPACT study had been “long-awaited” by the medical community.

“We believe these data will significantly contribute to the body of evidence on the use of single inhaler triple therapy, as well as the ongoing role of ICS/LABA and LAMA/LABA treatments in appropriate patients with COPD.”