Trelegy Ellipta Hits Phase 3 Asthma Marks, Eyes New Indication

Pivotal phase 3 trial results show benefits for once-daily furoate/umeclidinium/vilanterol (FF/UMEC/VI; Trelegy Ellipta) in patients with uncontrolled asthma when compared to standard FF/VU (Breo Ellipta) therapy.

In new CAPTAIN study data released by GlaxoSmithKline (GSK), the first US marketed triple-combination inhaler therapy showed statistically significant benefits for improved lung function at 24 weeks versus a standard dual therapy regimen. GSK now intends to include the positive findings for US Food and Drug Administration (FDA) regulatory review to expand FF/UMEC/VI’s indications even further.

Trelegy Ellipta was approved by the FDA for the long-term maintenance of chronic obstructive pulmonary disease (COPD) in September 2017. In April of last year, its indication was expanded to include the daily maintenance treatment of airflow obstruction in patients with COPD.

“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,” Hal Barron, MD, chief scientific officer and president of Research & Development at GSK, said in a statement. “We plan to submit these data for regulatory review after the full dataset is available.”

The double-blind, active controlled, six-arm parallel group, multi-center trial randomized patients with inadequately controlled asthma to either once-daily FF/UMEC/VI or FF/VI. Patients administered the triple therapy were given 1 of 4 doses: 100/31.25/25; 100/62.5/25; 200/31.25/25; or 200/62.5/25 mcg. FF/VI doses were either 100/25 or 200/25 mcg.

The trial involved 2436 patients across 15 countries, with each treatment arm including approximately 400 randomized patients each.

From baseline to 24 weeks, patients treated with 100/62.5/25 mcg triple therapy reported a statistically significant lung function improvement of 110 mL change in trough forced expiratory volume over 1 second (FEV₁) versus 100/25 mcg dual therapy (P< .001; 95% CI: 66-153).

They also found a statistically significant improvement in trough FEV₁ between 200/62.5/25 mcg triple therapy and 200/25 mcg dual therapy (92 mL; P< .001; 95% CI: 49-135).

Though 2 doses of FF/UMEC/VI (100/62.5/25 and 200/62.5/25) reached 13% reduced annualized rates of patient moderate/severe exacerbations—the study’s key secondary endpoint&mdash;the findings were not considered statistically significant.

Common adverse events across all 6 treatment arms included nasopharyngitis (13% to 15%), headache (5% to 9%), upper respiratory tract infection (3% to 6%) and bronchitis (3% to 5%). The safety profile for FF/UMEC/VI was found to be consistent with its known profile.

The full results of CAPTAIN are intended to be submitted and presented at upcoming scientific meetings and in peer-reviewed publications, according to GSK. The current data shows the therapy’s promise for an asthma indication.

“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,” Paul Meunier, PhD, vice president of Respiratory Medicine at Innoviva, said.