AstraZeneca Reports Topline Results From Phase III RESOLUTE COPD Trial Of Fasenra; Trial Misses Primary Endpoint But Safety Profile Maintained

AstraZeneca today announced that the Phase III RESOLUTE trial of Fasenra (benralizumab) in patients with chronic obstructive pulmonary disease (COPD) did not meet its primary endpoint, despite showing numerical improvement.

The trial evaluated Fasenra 100 mg in patients with moderate to very severe COPD with a history of frequent exacerbations and elevated blood eosinophil count (≥300 cells/µL). The primary endpoint was the annualised rate of moderate or severe exacerbations in patients with three or more exacerbations in the previous year.

Sharon Barr, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, said, “COPD, which remains a leading cause of death worldwide, is a complex, heterogeneous disease, and we continue to advance other promising approaches in our pipeline to address the unmet needs of patients. With its well-established ability to target and eliminate eosinophils, Fasenra has helped transform treatment of severe asthma, and more recently has demonstrated a significant effect in eosinophilic granulomatosis with polyangiitis and hypereosinophilic syndrome.”

While RESOLUTE did not achieve statistical significance, the safety and tolerability profile of Fasenra was consistent with its established clinical profile. AstraZeneca will conduct a full data analysis to better understand the outcomes, and the results will be shared with the scientific community at a future date.

Fasenra is already approved as an add-on maintenance therapy for severe eosinophilic asthma (SEA) in more than 80 countries, including the US, EU, Japan and China, as well as for eosinophilic granulomatosis with polyangiitis (EGPA) in over 60 countries. It is also under review for hypereosinophilic syndrome (HES). COPD remains a major global health burden, affecting an estimated 391 million people worldwide and ranking among the leading causes of morbidity and mortality.