Sanofi, Regeneron report all primary endpoints met in LIBERTY-AFRS-AIMS study

Results from the pivotal LIBERTY-AFRS-AIMS phase 3 study evaluating the investigational use of Dupixent in adults and children aged 6 years and older with allergic fungal rhinosinusitis demonstrated significant improvements in signs and symptoms of disease across all primary and secondary endpoints, including reductions in sinus opacification, nasal congestion, and nasal polyps compared to placebo. These are the first-ever positive phase 3 results specifically in AFRS and will be shared today at the American College of Allergy, Asthma and Immunology 2025 Annual Scientific Meeting, Orlando, FL, US. Recently, the US Food and Drug Administration accepted for priority review the supplemental biologics license application for Dupixent in adults and children aged 6 years and older with AFRS. Priority review is granted by the FDA to regulatory applications seeking approval for therapies that have the potential to provide significant improvements in the treatment, diagnosis, or prevention of serious conditions. If approved, AFRS would represent the ninth FDA-approved indication for Dupixent. In the LIBERTY-AFRS-AIMS study, 62 adults and children aged 6 years and older with AFRS were randomized to receive an age- and weight-based dose of Dupixent every two or four weeks or placebo. The differences for Dupixent compared to placebo were as follows: Primary Endpoint: Sinus opacification scores improved by 50.0% in the Dupixent group versus 9.8% in the placebo group at 52 weeks; a significant reduction in sinus opacification scores was also observed at 24 weeks. Secondary Endpoints: Patient-reported nasal congestion/obstruction improved by 66.7% in the Dupixent group versus 25.3% in the placebo group at 24 weeks, with continued improvement at 52 weeks to 80.6% in the Dupixent group compared to 11.1% in the placebo group. Nasal polyp size reduced by 60.8% in the Dupixent group compared to 15.2% in the placebo group at 24 weeks, with continued reduction of 62.5% in the Dupixent group compared to 3.6% in the placebo group up to 52 weeks. 92% lower risk of systemic corticosteroid use and/or in need of surgery in the Dupixent group compared to placebo. over 52 weeks. The safety in the study was generally consistent with the known safety profile of Dupixent in its approved respiratory indications. The overall rates of adverse events were 70% with Dupixent and 79% with placebo. The most common treatment-emergent AEs occurring more frequently in Dupixent compared to placebo included COVID-19 and nosebleed. Serious AEs were reported in 0% and 7% of patients treated with Dupixent and placebo, respectively. Additionally, AEs leading to study treatment discontinuation were reported in 3% of Dupixent patients and 4% of placebo patients. The safety and efficacy of Dupixent in AFRS have not been fully evaluated by any regulatory authority.