GSK, Innoviva’s Trelegy Ellipta meets primary endpoint in phase III asthma study

Trelegy Ellipta is a once-daily single inhaler triple therapy, which includes fluticasone furoate (FF), umeclidinium (UMEC) and vilanterol (VI).

Fluticasone is an inhaled corticosteroid, while umeclidinium is a long-acting muscarinic antagonist and vilanterol is a long-acting beta agonist.

GSK chief scientific officer and R&D president Dr 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.”

The CAPTAIN is a randomized, double-blind, active controlled, six-arm parallel group and global multicenter trial designed to assess FF/UMEC/VI (100/31.25/25, 100/62.5/25, 200/31.25/25 and 200/62.5/25 mcg) against Relvar/Breo Ellipta (FF/VI) given once-daily to patients whose asthma is inadequately controlled despite treatment with ICS/LABA maintenance asthma medication.

In the trial, the 2,436 patients have been treated across 15 countries with around 400 patients randomly assigned to each of the six treatment arms.

The study has showed a statistically significant 110mL improvement in lung function for FF/UMEC/VI 100/62.5/25mcg compared with Relvar/Breo 100/25mcg and a statistically significant 92mL improvement in trough FEV₁ for FF/UMEC/VI 200/62.5/25mcg against Relvar/Breo 200/25mcg.

The major secondary endpoint was annualized rate of moderate/severe exacerbations for FF/UMEC/VI (100/62.5/25 and 200/62.5/25) against Relvar/Breo (100/25 and 200/25). GSK’s study showed a 13% reduction in exacerbations, which is statistically not significant.

GSK has designed CAPTAIN study to assess two further doses of FF/UMEC/VI (100/31.25/25 and 200/31.25/25 mcg) compared to Relvar/Breo(100/25 and 200/25).

With no difference in exacerbation rates, there have been increases in trough FEV₁ of a similar magnitude to those of FF/UMEC/VI 100/62.5/25 and 200/62.5/25.

According to the company, the safety profile of FF/UMEC/VI was consistent with the known profile of the individual components and their combinations.

Innoviva respiratory medicine vice president Dr Paul Meunier said: “The CAPTAIN study has shown that triple therapy in a single inhaler provides a potential new treatment option for asthma management in patients uncontrolled on ICS/LABA.”