Sanofi and Regeneron’s Dupixent appears to be closing in on an FDA nod to expand its label to chronic obstructive pulmonary disorder (COPD). Data presented Monday at the American Thoracic Society (strengthen the company’s case for an approval. (Sanofi)
At the American Thoracic Society international conference in San Diego, one of the major themes is the advance of new therapies for chronic obstructive pulmonary disease (COPD).
One day after AstraZeneca and Amgen presented midstage data on their biologic treatment Tezspire (tezepelumab) that missed the trial’s primary objective but still showed promise in certain groups of COPD patients, Sanofi and Regeneron chimed in with an update on their versatile biologic Dupixent (dupilumab), which is closing in on a potential COPD approval.
The NOTUS trial—the second of two phase 3 studies the companies have conducted in COPD—aced its primary objective, as Dupixent provided a 34% reduction versus placebo in moderate or severe exacerbations for patients on maximal standard-of-care treatment with a blood eosinophil count (BEC) of 300 cells or greater/µL (per microliter) and with type 2 inflammation. The figure matched that from interim analysis of the trial in November.
NOTUS also met key secondary endpoints, including a more than two-times improvement in lung function versus placebo at 12 weeks, with the edge maintained at Week 52. There also were improvements in health-related quality of life metrics from baseline to Week 52, as defined by the St. George’s Respiratory Questionnaire. Additionally, in another patient-reported outcomes measure, there were numerically greater reductions in respiratory system severity from baseline to Week 52.
“Too many patients” struggle with COPD exacerbations that lead to a loss of lung function and a rapidly declining quality of life,” co-principal investigator Surya Bhatt, M.D., said in a statement.
“In NOTUS, dupilumab reduced exacerbations by a magnitude never seen before with an investigational biologic in a phase 3 COPD clinical study,” said Bhatt, who is a professor in the pulmonary, allergy and critical care medicine division at the University of Alabama at Birmingham. “These comprehensive results reinforce that, if approved, dupilumab could provide a first-of-its-kind medical advancement for the COPD community.”
The results confirmed previous data from the 3 BOREAS trial in which Dupixent produced a 30% reduction in exacerbations in patients with the same disease profile.
In both trials, results backed up the safety profile of Dupixent in its approved indications—which include atopic dermatitis, asthma, rhinosinusitis, prurigo nodularis and eosinophilic esophagitis. Adverse events leading to deaths in NOTUS were 2.6% for Dupixent compared to 1.5% for placebo.