Another pivotal study fail dashes AstraZeneca's hopes for Fasenra in COPD

AstraZeneca's ambitions of expanding use of Fasenra (benralizumab) to include patients with chronic obstructive pulmonary disease (COPD) have been dealt another blow with the failure of a third Phase III study. 

Following setbacks in the GALATHEA and TERRANOVA trials in 2018 — which included patients with moderate-to-very severe COPD with a history of exacerbations across a range of baseline blood eosinophils — the company initiated the RESOLUTE study to zero in on those with eosinophil counts ≥300 cells/µL.

Expectations for success in RESOLUTE were buoyed by recent positive findings from GSK's Phase III MATINEE trial of the IL-5-targeting monoclonal antibody Nucala (mepolizumab). However, experts who spoke with FirstWord earlier this year for a report on the COPD landscape cautioned that given the particularly negative results seen in GALATHEA and TERRANOVA, AstraZeneca's IL-5-targeting monoclonal antibody only had a reasonable chance of hitting the main goal in RESOLUTE.

And the company confirmed this outcome on Wednesday, noting that despite showing numerical improvement, Fasenra failed to achieve statistical significance on RESOLUTE's primary endpoint of the annualised rate of moderate-to-severe exacerbations in patients with three or more exacerbations in the previous year. AstraZeneca indicated that it will analyse the full data set to further understand the results.

Fasenra is currently approved in a number of markets as an add-on maintenance treatment for severe eosinophilic asthma, as well as for adults with eosinophilic granulomatosis with polyangiitis. The therapy — in-licensed from Kyowa Kirin's BioWa unit — is also under regulatory review for the treatment of hypereosinophilic syndrome.