Sanofi and Regeneron’s Dupixent (dupilumab) has continued to show promise as an add-on maintenance treatment for chronic obstructive pulmonary disease (COPD), according to late-stage results presented at this year’s American Thoracic Society International Conference.
The phase 3 NOTUS trial has been evaluating the investigational use of Dupixent compared to placebo in adults with uncontrolled COPD who are on maximal standard-of-care inhaled therapy and have evidence of type 2 inflammation.
The trial met its primary endpoint, with Dupixent shown to reduce moderate or severe COPD exacerbations by 34% versus placebo over 52 weeks.
The results, simultaneously published in the New England Journal of Medicine, also showed that patients receiving Dupixent experienced a more than two-times improvement in lung function versus placebo at 12 weeks, with this benefit maintained at week 52.
Numerically greater improvements in health-related quality of life and reductions in respiratory symptom severity from baseline to 52 weeks were also observed in the Dupixent cohort, and safety results were generally consistent with the known safety profile of the therapy.
COPD is a chronic respiratory disease that causes progressive lung function decline. In the US, approximately 300,000 people live with uncontrolled COPD and evidence of type 2 inflammation.
Dupixent is a fully human monoclonal antibody that inhibits the signalling of the interleukin-4 and interleukin-13 pathways, shown in the Dupixent development programme to be central drivers of the type 2 inflammation that plays a major role in multiple related and often comorbid diseases.
The positive data from NOTUS builds on the previous results from the phase 3 BOREAS trial, in which Dupixent demonstrated a 30% reduction in moderate or severe acute COPD exacerbations in the same patient population.
A co-principal investigator of the confirmatory study, Surya Bhatt, the University of Alabama at Birmingham, said: “In NOTUS, [Dupixent] reduced exacerbations by a magnitude never seen before with an investigational biologic in a phase 3 COPD clinical study.
“These comprehensive results reinforce that, if approved, [Dupixent] could provide a first-of-its-kind medical advancement for the COPD community.”
Dupixent has already been granted priority review by the US Food and Drug Administration as an add-on maintenance treatment in certain adult patients with uncontrolled COPD and evidence of type 2 inflammation, with a target action date of 27 June 2024 set.
Regulatory submissions for use of the therapy in COPD are also under review in the EU and China, and discussions with other regulatory authorities around the world are ongoing.