GSK acquired Tesaro, which developed dostarlimab in alliance with AnaptysBio. Credit: GSK.

GlaxoSmithKline’s (GSK) once-daily single inhaler triple therapy Trelegy Ellipta has met the primary endpoint of a Phase III CAPTAIN study in patients with uncontrolled asthma.

Trelegy Ellipta is a combination of fluticasone furoate, umeclidinium and vilanterol (FF/UMEC/VI). Trelegy is delivered in GSK’s Ellipta dry powder inhaler.

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The study evaluated Trelegy Ellipta versus Relvar/Breo Ellipta (FF/VI).

The trial met the primary endpoint showing a statistically significant 110ml improvement in lung function and a statistically significant 92ml improvement in Trough Forced Expiratory Volume in 1 second (FEV1) with Trelegy Ellipta, compared to Relvar/Breo.

“We plan to submit these data for regulatory review after the full dataset is available.”

However, the trial failed to meet the secondary endpoint of annualised rate of moderate / severe exacerbations.

According to the headline data from the pivotal Phase III CAPTAIN study, the safety profile of the triple therapy was consistent with the known profile of its individual components and their combinations.

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The most common adverse events observed during the trial were as nasopharyngitis, headache, upper respiratory tract infection and bronchitis.

GSK chief scientific officer and R&D president Hal Barron said: “We believe a once-daily single inhaler triple therapy that improves lung function is an advance for patients with uncontrolled asthma since this option is not currently available. We plan to submit these data for regulatory review after the full dataset is available.”

In the US, Trelegy is indicated for the long-term, once-daily, maintenance therapy of airflow obstruction in COPD patients.

The randomised, double-blind, active controlled, six-arm parallel group, multi-centre CAPTAIN trial assessed once-daily FF/UMEC/VI in individuals whose asthma is not adequately controlled even after treatment with ICS/LABA maintenance asthma medication.

During the study, a total of 2,436 patients were enrolled at clinical sites across 15 countries.