Sanofi and Regeneron’s Dupixent (dupilumab) could be set for its ninth US approval after the drug met all the primary and secondary endpoints in a Phase III study in allergic fungal rhinosinusitis (AFRS).
In the pivotal LIBERTY-AFRS-AIMS trial (NCT04684524), sinus opacification scores improved by 50% in the Dupixent group compared to 9.8% in the placebo group at 52 weeks, meeting the trial's primary endpoint. Sinus opacification is a measure of nasal congestion as assessed by computed tomography (CT) scans.
Patient-reported nasal congestion/obstruction improved by 66.7% in the Dupixent group versus 25.3% in the placebo group at 24 weeks. Improvement continued 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.
Finally, there was a 92% lower risk of systemic corticosteroid use or need for surgery in the Dupixent group.
The safety profile of Dupixent was generally consistent with the known profile in approved respiratory indications.
Dr Amber Luong, professor and vice chair for academic affairs in the department of otorhinolaryngology at the McGovern Medical School of the University of Texas Health Science Center, said: “This study is significant as it is the first positive Phase III study for an investigational treatment specifically for AFRS. The ability of Dupixent to alleviate the hallmark signs and symptoms of AFRS, and to reduce the risk for surgery and corticosteroids by 92%, provides the strongest evidence to date that IL4 and IL13 are key drivers of the type 2 inflammation leading to this disease, as they seem to be for multiple other type 2 inflammatory diseases.”
The US Food and Drug Administration (FDA) has accepted priority review of the supplemental biologics license application (sBLA) for Dupixent in AFRS. If approved, AFRS would represent the ninth FDA-approved indication for Dupixent.
Dupixent is one of the top-selling drugs in the world, with 2024 sales of $14.15bn. GlobalData analysis predicts that sales of Dupixent will grow year-on-year, with a 2031 annual sales and consensus forecast of $25.42bn.
GlobalData is the parent company of Clinical Trials Arena.
AFRS, a subtype of chronic rhinosinusitis, is a chronic type 2 inflammatory disease of the sinuses caused by an intense allergic hypersensitivity to fungi, most usually aspergillus. The current standard-of-care (SoC) is surgery and prolonged courses of systemic steroids; however, disease recurrence can occur.
