AstraZeneca’s Phase III RESOLUTE Trial of Fasenra in COPD Misses Primary Endpoint

AstraZeneca’s Phase III RESOLUTE Trial of Fasenra in COPD Misses Primary Endpoint

By, Admin 19 September 2025

AstraZeneca announced results from the RESOLUTE phase III trial of its biologic Fasenra (benralizumab) in patients with chronic obstructive pulmonary disease (COPD). While the study showed numerical improvements, it did not meet statistical significance for its primary endpoint.

Company Statement

Sharon Barr, EVP, Biopharmaceuticals R&D at AstraZeneca, commented:

“COPD remains a leading cause of death worldwide and is a complex, heterogeneous disease. We continue to advance other promising approaches in our pipeline to address unmet needs. With its ability to target and eliminate eosinophils, Fasenra has transformed treatment in severe asthma and shown benefit in other eosinophil-driven diseases.”

The safety and tolerability profile of Fasenra in RESOLUTE was consistent with its known safety record. AstraZeneca will conduct full data analyses and share results with the scientific community.

About the RESOLUTE Trial

  • Design: Randomised, double-blind, placebo-controlled phase III trial
  • Participants: 689 people with moderate-to-very severe COPD, frequent exacerbations, and blood eosinophil count ≥300 cells/μL
  • Intervention:
    - Fasenra 100 mg every 4 weeks for 3 doses, then every 8 weeks
    - Placebo solution
    - All patients remained on ICS/LABA/LAMA background therapy
  • Endpoints:
    - Primary: Annualised rate of moderate/severe exacerbations in patients with ≥3 exacerbations in the prior year
  • Key secondary endpoints:
    - Annualised rate of severe exacerbations
    - Change from baseline in SGRQ (St. George’s Respiratory Questionnaire) score
    - Change from baseline in pre-bronchodilator FEV1 at Week 56

Definitions used in RESOLUTE:

  • Moderate exacerbation: Symptomatic worsening requiring systemic corticosteroids (≥3 days) and antibiotics
  • Severe exacerbation: Hospitalisation or death due to COPD

The trial design was informed by findings from the prior GALATHEA and TERRANOVA phase III studies.

COPD Burden

  • COPD is a progressive, irreversible, and debilitating disease.
  • Exacerbations accelerate lung damage, hospitalisations, and mortality.
  • COPD affects 391 million people globally and is among the leading causes of morbidity and death.

Fasenra Approvals & Development

  • Approved indications:
    - Severe eosinophilic asthma (SEA): Add-on maintenance therapy in >80 countries, including the US, Japan, EU, and China
    - SEA in children (≥6 years): Approved in the US and Japan
    - Eosinophilic granulomatosis with polyangiitis (EGPA): Approved in >60 countries for adults
  • Under review: Hypereosinophilic syndrome (HES)
  • Patients: More than 150,000 patients worldwide currently on Fasenra

Other trial highlights:

  • NATRON phase III trial in HES met its primary endpoint, with Fasenra showing a statistically significant delay in time to first worsening/flare compared to placebo.
  • Fasenra is dosed monthly in a single injection.

Drug Origin & Company Focus

  • Fasenra was developed by AstraZeneca and in-licensed from BioWa, Inc., a subsidiary of Kyowa Kirin (Japan).
  • Respiratory & Immunology is a growth driver for AstraZeneca, with a 50-year legacy in respiratory care.
  • The company is expanding a pipeline of biologics, inhaled medicines, and new modalities with the aim to:
    - Eliminate COPD as a leading cause of death
    - Eliminate asthma attacks
    - Achieve clinical remission in immune-mediated diseases

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