Dupixent Becomes First Biologic to Demonstrate Significant Benefit in COPD in Pivotal Phase 3 BOREAS Trial

On March 23, Regeneron/Sanofi jointly announced the success of the pivotal Phase III BOREAS study of Dupixent (dupilumab) for the treatment of chronic obstructive pulmonary disease (COPD). This also marks Dupixent (dupilumab) as the first biologic to significantly improve lung function in patients with COPD.

COPD is a very common chronic airway disease with no cure currently available, and symptoms can only be alleviated through medication. For patients with less severe COPD, using a single bronchodilator (β2 agonists, anticholinergics, or theophylline drugs) may achieve the treatment goal; however, patients with more severe conditions often require the combination of two or more medications to improve their symptoms.

BOREAS is a randomized, double-blind, placebo-controlled Phase III study designed to evaluate the efficacy, safety, and tolerability of Dupixent in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD) associated with type 2 inflammation in the airways. The study enrolled 939 patients aged 40 to 80 with moderate-to-severe COPD, who were randomly assigned to receive Dupixent or placebo every two weeks, in addition to triple therapy with inhaled corticosteroids (ICS), long-acting beta-agonists (LABA), and long-acting muscarinic antagonists (LAMA). If ICS treatment was not tolerated, dual maintenance therapy (LABA+LAMA) was used.

The primary endpoint of the BOREAS study was the rate of acute exacerbations of moderate to severe COPD within 52 weeks. Key secondary endpoints included baseline changes in lung function at 12 and 52 weeks (assessed by pre-bronchodilator FEV1), changes in the total score of the St. George's Respiratory Questionnaire (SGRQ) at week 52, the proportion of patients with an SGRQ improvement ≥4 points at week 52, and changes in symptom scores on the ERS: COPD scale at week 52.

Data showed that the BOREAS study met the primary endpoint, with a 30% reduction in acute exacerbations of moderate to severe COPD within 52 weeks (p=0.0005). Meanwhile, at week 12, patients in the Dupixent treatment group experienced a 160mL improvement in FEV1 from baseline, compared to 77mL in the placebo group (p<0.0001). Additionally, the BOREAS study achieved all secondary endpoints, including improvements in quality of life as measured by SGRQ and reductions in the severity of COPD respiratory symptoms as assessed by the ERS: COPD scale.

In terms of safety, the BOREAS study data is generally consistent with the safety data of Dupixent's approved indications. The total incidence of adverse events (AE) in the Dupixent treatment group was 77%, compared to 76% in the placebo group.

In addition, the second Phase III NOTUS study of Dupixent for the treatment of COPD is also underway, with data expected in 2024.

Regeneron President and Chief Scientific Officer George D. Yancopoulos said, "COPD is a global health issue. Due to the variability among individuals, COPD is very difficult to treat, and no new treatments have been approved for over a decade. In this landmark Phase III study, Dupixent significantly improved disease symptoms and quality of life in COPD patients. We look forward to discussing these exciting results with regulatory authorities."

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