Today, we are looking at the MATINEE study, a phase III clinical trial investigating GlaxoSmithKline's Nucala (mepolizumab) in adults with chronic obstructive pulmonary disease (COPD). Nucala is a monoclonal antibody that targets interleukin-5 (IL-5) and was initially approved by the FDA in 2015 for severe asthma with an eosinophilic phenotype. Since then, it has been approved as an add-on maintenance treatment for chronic rhinosinusitis with nasal polyps (CRSwNP) and the treatment of eosinophilic granulomatosis with polyangiitis (EGPA) in adult patients.

According to the World Health Organization, COPD is the fourth leading cause of death worldwide, claiming 3.5 million lives in 2021. Tobacco smoking is the leading cause of COPD in high-income countries, while household air pollution is a significant risk factor in low- and middle-income countries.

While COPD is not curable, symptoms can be managed through lifestyle changes, vaccinations, medications, oxygen therapy, and pulmonary rehabilitation. Additional therapies are crucial in improving the quality of life for individuals with COPD.

The MATINEE trial enrolled COPD patients with chronic bronchitis and/or emphysema who were already receiving optimized inhaled maintenance therapy. Participants also had evidence of type 2 inflammation characterized by elevated eosinophil counts. The study successfully met its primary endpoint, demonstrating that the addition of Nucala to inhaled maintenance therapy led to a significant reduction in the rate of moderate/severe exacerbations compared to a placebo over a 104-week treatment period.

Here is a brief overview of the study:

Mepolizumab as Add-on Treatment IN Participants With COPD Characterized by Frequent Exacerbations and Eosinophil Level (MATINEE)

Study Details | Source

  • Sponsor: GlaxoSmithKline
  • This is a multi-center, randomized, placebo-controlled, double-blind, parallel group study designed to confirm the benefits of mepolizumab treatment on moderate or severe exacerbations in chronic obstructive pulmonary disease (COPD) participants given as an add on to their optimized maintenance COPD therapy. The maximum duration of participant participation is approximately 109 weeks, consisting of 2 screening visits (up to 3 weeks), a run-in period (up to 2 weeks), and an intervention period of at least 52 weeks and up to 104 weeks. 800 participants will be randomized in a 1:1 ratio to receive mepolizumab 100 milligrams (mg) or placebo every 4 weeks for at least 13 doses (52 weeks treatment period) up to a maximum of 26 doses (104 weeks treatment period). The number of randomized participants may increase up to approximately 1400.
  • Interventions:
    • Drug: Placebo
    • Biological: Mepolizumab
  • Primary Outcomes Measures:
    • Annualized rate of moderate or severe exacerbations
      • Moderate exacerbations are defined as clinically significant exacerbations that require treatment with oral or systemic corticosteroids and/or antibiotics. Severe exacerbations are defined as clinically significant exacerbations that require in-patient hospitalization (>=24 hours) or result in death. The frequency of moderate or severe exacerbations expressed as an annualized exacerbation rate will be evaluated.
      • Time Frame - Up to Week 104

On December 9, 2024, the Food and Drug Administration accepted for review the Biologics License Application (BLA) for mepolizumab as an add-on maintenance treatment for chronic obstructive pulmonary disease (COPD) with an eosinophilic phenotype. The Prescription Drug User Fee Act (PDUFA) date for a decision has been set for May 7, 2025. It will be intriguing to observe whether Nucala will be approved as a treatment option for COPD.

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