On November 27, the 2nd Phase III NOTUS study of Dupixent for chronic obstructive pulmonary disease (COPD) met its primary endpoint and was able to reduce acute exacerbations in patients with moderate-to-severe COPD by 34%, further confirming the positive results of the first Phase III BOREAS study (First! successful Phase III study of Dupixent in COPD). Regenergen and Sanofi plan to submit a marketing application for this indication by the end of 2023.
COPD is a very common chronic airway disease for which there are currently no new treatments available in the last decade, and only medications are available to relieve symptoms. For patients with less severe COPD, only one bronchodilator (β2 agonist, anticholinergic, theophylline) can be used. However, patients with severe disease usually need a combination of two or more medications to improve their symptoms.
The NOTUS study is the 2nd Phase III clinical trial conducted by Regenerative Elements/Sanofi of Dupixent for the treatment of moderate-to-severe COPD and is designed to evaluate the efficacy, safety, and tolerability of Dupixent in adult COPD patients currently receiving maximal standard inhalation therapy (triple therapy) with concomitant type 2 inflammation (blood eosinophils ≥300 cells/μL). The study included 935 patients with an age distribution of 40-85 years and current or former smokers.
Results showed a 34% reduction in acute exacerbations of moderate-to-severe COPD in the Dupixent treatment group over 52 weeks (p=0.0002), meeting the primary endpoint. Meanwhile, at week 12, patients in the Dupixent-treated group showed an improvement in lung function (lung function assessed by pre-bronchodilator FEV1) of 139mL from baseline compared to the corresponding value of 57mL in the placebo group (p=0.0001), with the benefit continuing through week 52 (115mL in the Dupixent group versus 54mL in the placebo group, p=0.0182).
With respect to safety, data from the NOTUS study were generally consistent with safety data for the approved indications for Dupixent.The overall incidence of adverse events (AEs) was 67% in the Dupixent treatment group and 66% in the placebo group.
Dr. Naimish Patel, Global Head of Development, Immunology and Inflammation, Sanofi: "This is the first and only COPD investigational biologic to show a significant and clinically meaningful reduction in exacerbations in two Phase III trials. We are pleased to be able to make Dupixent available more quickly to patients in need."