Don Tracy, Associate Editor
Trial results expected to accelerate the potential of Dupixent to become the first FDA-approved treatment for chronic obstructive pulmonary disease.
Regeneron Pharmaceuticals and Sanofi have announced that a Phase 3 trial evaluating Dupixent (dupilumab) in the treatment of chronic obstructive pulmonary disease (COPD) showed the drug reduced exacerbations by 34%, reportedly confirming positive results from its earlier Phase 3 BOREAS trial. According to a Regeneron press release, the NOTUS trial also confirmed that treatment led to rapid and significant improvements in lung function by 12 weeks and were sustained at 52 weeks.
Back in May, the companies also announced the success of the aforementioned BOREAS trial for investigational use of Dupixent in adults currently on maximal standard-of-care inhaled therapy (triple therapy) with COPD and evidence of type 2 inflammation. Earlier this year, the drug was granted FDA Breakthrough Therapy designation as an add-on maintenance treatment in adult patients with uncontrolled COPD associated with a history of exacerbations and an eosinophilic phenotype.
“This is the first and only time an investigational biologic in COPD has shown a significant and clinically meaningful reduction in exacerbations in two Phase 3 trials and we are pleased that we can potentially deliver Dupixent faster to patients in need where no new advancements have been identified in over a decade,” said Naimish Patel, MD, head of global development, immunology and inflammation, Sanofi, in the aforementioned release. “These data validate our belief that Dupixent has the potential to transform the treatment of moderate-to-severe COPD and given the significant unmet needs for patients with uncontrolled COPD, we are not stopping with Dupixent. Our second program in COPD, itepekimab, continues with data expected in 2025. If positive, Dupixent and itepekimab could emerge as treatments for approximately 80% of those suffering from moderate-to-severe COPD with recurrent exacerbations.”
The NOTUS trial included 935 adult patients who were current or former smokers aged 40 to 85 years and randomly assigned to receive Dupixent or placebo, which was added to maximal standard-of-care inhaled therapy. Results indicated that patients on the drug experienced a 34% reduction in moderate to severe acute COPD over 52 weeks, and an improved lung function from baseline by 139 mL at 12 weeks compared to 57 mL for placebo. Previously, the BOREAS study found a 30% reduction in moderate or severe acute COPD exacerbations over 52 weeks, and improved lung function from baseline by 160 mL at 12 weeks compared to 77 mL for placebo.
The Boreas study also found a 9.7-point improvement in health-related quality of life from baseline at 52 weeks and a 2.7-point reduction in respiratory symptom severity.
“I've seen patients with uncontrolled chronic obstructive pulmonary disease struggle for far too long with the debilitating symptoms of this progressive disease – with limited, incremental improvement on current treatment options,” said Surya Bhatt, MD, MSPH, associate professor, University of Alabama at Birmingham Division of Pulmonary, Allergy, and Critical Care Medicine, and a co-principal investigator of the trial, in a company press release. “This trial showed that dupilumab has the potential to impact the vicious cycle of exacerbations and lung function decline in patients with uncontrolled COPD with type 2 inflammation, and significantly improve respiratory symptoms. Dupilumab also helped improve health-related quality of life measures, which, from my years of experience as a physician, are just as meaningful for patients as being able to breathe easier.”