Asthma Watch: Trelegy Ellipta Hits Phase 3 Asthma Marks, Eyes New Indication
Pivotal phase 3 trial results show benefits for once-daily fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI; Trelegy Ellipta) in patients with uncontrolled asthma compared with standard FF/VI (Breo Ellipta) therapy.
Pivotal phase 3 trial results show benefits for once-daily fluticasone furoate/ umeclidinium/vilanterol (FF/UMEC/VI; Trelegy Ellipta) in patients with uncontrolled asthma compared with standard FF/VI (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 plans to submit the positive findings for FDA regulatory review to expand FF/ UMEC/VI’s indications even further.
In September 2017, the FDA approved FF/UMEC/VI for the long-term maintenance of chronic obstructive pulmonary disease (COPD). In April 2018, the agency expanded the indication to include the daily maintenance treatment of airflow obstruction in patients with COPD.
The double-blind, active-controlled, 6-arm parallel group, multicenter 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: 100.0/31.25/25.0, 100.0/62.5/25.0, 200.0/31.25/25.0, or 200.0/62.5/25.0 μg. FF/VI doses were either 100.0/25.0 or 200.0/25.0 μg.
The trial involved 2436 patients across 15 countries, with each treatment arm including about 400 randomized patients. From baseline to 24 weeks, patients treated with 100.0/62.5/25.0-μg triple therapy demonstrated a statistically significant lung function improvement of 110-mL change in trough forced expiratory volume over 1 second (FEV1) versus 100.0/25.0-μg dual therapy (95% CI, 66-153, P <.001). Investigators also found a statistically significant improvement in trough FEV1 between 200.0/62.5/25.0-μg triple therapy and 200.0/25.0-μg dual therapy (92 mL; 95% CI, 49-135; P <.001).
Phase III CAPTAIN study of Trelegy Ellipta in patients with asthma meets primary endpoint [news release]. London, United Kingdom: GlaxoSmithKline plc and Innoviva Inc; May 2, 2019. gsk.com/en-gb/media/press-release/phase-iii-captain-study-of-trelegy-ellipta-in-patients-with-asthma-meets-primary-endpoint/. Accessed July 22, 2019.