New research on triple therapy in advance of PBS listing

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GSK and Innoviva have welcomed the publication of the landmark IMPACT study.

The study is one of the biggest ever conducted in patients with moderate to severe chronic obstructive pulmonary disease (COPD) with a history of exacerbation.

In the study, GSK's triple combination TRELEGY ELLIPTA (fluticasone furoate and umeclidinium and vilanterol) achieved superiority to the company's PBS-listed ANORO ELLIPTA (umeclidinium and vilanterol) and BREO ELLIPTA (fluticasone furoate and vilanterol) on the primary endpoint of reduction in the annual rate of on-treatment moderate to severe exacerbations.

The Pharmaceutical Benefits Advisory Committee recommended TRELEGY ELLIPTA in December 2018. It is the first single inhaler triple therapy for the treatment of COPD.

The study showed a 25 percent reduction for TRELEGY ELLIPTA compared to ANORO ELLIPTA in the annual rate of on-treatment moderate to severe exacerbations. It was a 15 percent reduction for TRELEGY ELLIPTA compared to BREO ELLIPTA.

Results from an additional secondary endpoint showed a 34 percent reduction in COPD hospitalisations for TRELEGY ELLIPTA compared to ANORO ELLIPTA and 13 percent compared to BREO ELLIPTA.

In Australia, COPD exacerbations account for around 355,328 hospital bed days and 15 percent of all potentially preventable hospitalisations each year.

According to GSK Australia medical director Andrew Weekes, “The results have important implications for Australia. These positive results are particularly relevant here given the local impact of COPD and the fact that TRELEGY ELLIPTA is the subject of a positive PBS recommendation from the Pharmaceutical Benefits Advisory Committee,” said Weekes.