Regeneron Pharmaceuticals, Inc. and Sanofi presented late-breaking data from the NOTUS Phase 3 trial evaluating the investigational use of Dupixent® (dupilumab) as an add-on maintenance treatment in adults with uncontrolled COPD on maximal standard-of-care inhaled therapy (nearly all on triple therapy) and evidence of type 2 inflammation (i.e., blood eosinophils =300 cells per µL). The NOTUS trial confirmed the positive results demonstrated in the landmark Phase 3 BOREAS trial, with its data presented at a late-breaking session of the 2024 American Thoracic Society (ATS) International Conference and simultaneously published in the New England Journal of Medicine (NEJM). As presented and published, the NOTUS trial met its primary and key secondary endpoints.

All patients were on background maximal standard-of-care inhaled therapy (nearly all on triple therapy). Patients receiving Dupixent (n=470) experienced the following, compared to placebo (n=465): 34% reduction in moderate or severe COPD exacerbations over 52 weeks. More thantwo times greater improvement in lung function (pre-bronchodilator FEV1) from baseline at 12 weeks (139 mL vs.

57 mL; Numerically greater improvements in health-related quality of life from baseline at 52 weeks, a secondary endpoint, as defined by patient-reported outcomes (PRO) in the St. George?s Respiratory Questionnaire (SGRQ). Numerically greater reductions in respiratory symptom severity from baseline to 52 weeks, a secondary endpoint, as defined by PROs in Evaluating Respiratory Symptoms in COPD (E-RS).

The safety results were generally consistent with the known safety profile of Dupixent in its approved indications. Overall rates of adverse events (AE) were 67% for Dupixent and 66% for placebo. AEs more commonly observed with Dupixent than placebo included COVID-19 (9.4% Dupixent, 8.2% placebo), nasopharyngitis (6.2% Dupixent, 5.2% placebo), and headache (7.5% Dupixent, 6.5% placebo).

AEs more commonly observed with placebo than Dupixent included COPD (7.8% placebo, 4.9% Dupixent). AEs leading to deaths were 2.6% for Dupixent and 1.5% for placebo.