AstraZeneca announced top-line results from the AERISTO Phase IIIb trial for Bevespi Aerosphere (glycopyrronium/formoterol fumarate) in patients with moderate to very severe chronic obstructive pulmonary disease (COPD). In the trial, Bevespi Aerosphere demonstrated non-inferiority to umeclidinium/vilanterol (Anoro Ellipta from GSK) on peak forced expiratory volume in one second (FEV1) but did not demonstrate superiority on peak FEV1 or non-inferiority on trough FEV1.
Dr Colin Reisner, Head of Respiratory, Global Medicines Development, said: “The efficacy and safety of Bevespi Aerosphere has been established by the Phase III PINNACLE trial programme involving more than 5,000 patients. The performance of Bevespi Aerosphere in AERISTO is inconsistent with previous data. A full analysis is underway to understand and characterise these findings and will be presented at a forthcoming medical meeting.”
The 24-week AERISTO Phase IIIb trial was a randomised, double-blinded, double-dummy, multicentre, parallel-group trial designed to assess the efficacy and safety of Bevespi Aerosphere compared with umeclidinium/vilanterol. The primary endpoints were peak change from baseline in FEV1 where non-inferiority and superiority were measured and change from baseline in trough FEV1 where non-inferiority was measured. In the trial, 1,119 patients were randomised to receive either two inhalations twice a day of Bevespi Aerosphere (glycopyrronium/formoterol fumarate 7.2/4.8µg) via pressurised metered-dose inhaler or one inhalation once a day of umeclidinium/vilanterol 62.5/25µg via dry powder inhaler. Safety and tolerability data for Bevespi Aerosphere were consistent with the known profile of the medicine.
Bevespi Aerosphere is approved in the US and Canada for the long-term maintenance treatment of airflow obstruction in COPD. Bevespi Aerosphere is currently under review by the European Medicines Agency with a regulatory decision anticipated in the second half of 2018.