Sanofi, Regeneron's Dupixent hits main goals of two late-stage studies for chronic rhinosinusitis with nasal polyps

Sanofi and Regeneron Pharmaceuticals said Tuesday that two late-stage studies of Dupixent (dupilumab) in adults with inadequately-controlled chronic rhinosinusitis with nasal polyps met all their primary and secondary endpoints. John Reed, global head of R&D at Sanofi, remarked "for the first time, we have Phase III data showing that a biologic can help address the underlying Type 2 or allergic inflammation that causes chronic rhinosinusitis with nasal polyps."

The trials, dubbed SINUS-24 and SINUS-52, enrolled 276 and 448 patients, respectively, who were 18 years or older with bilateral nasal polyps who, despite treatment with systemic corticosteroids in the previous two years or history of surgery, continued to have ongoing moderate or severe symptoms of nasal congestion, blockage, loss of smell or nasal discharge. Subjects were randomised to receive Dupixent when added to the corticosteroid mometasone furoate nasal spray (MFNS), compared to MFNS alone.

The studies had the same co-primary goals, which were change from baseline in nasal congestion/obstruction severity based on the patient's daily morning assessment, and change from baseline in nasal polyposis score after 24 weeks, as assessed by nasal endoscopy. The companies noted that an additional co-primary endpoint in Japan, which was a key secondary goal in other countries, was change from baseline in sinus opacification, as assessed by computed tomography scan.

Results showed that for both trials at 24 weeks, patients treated with Dupixent in addition to MFNS spray experienced a 51 percent and 57 percent improvement in their nasal congestion/obstruction severity compared to 15 percent and 19 percent improvement with nasal spray alone. Sanofi and Regeneron added that Dupixent treated patients had a 27 percent and 33 percent reduction in their nasal polyps score compared to a 4 percent and 7 percent increase for placebo.

The drugmakers noted that Dupixent also met all secondary endpoints in the trials, including demonstrating a significant reduction in the need for systemic corticosteroids or surgery, and improvements in smell and chronic rhinosinusitis symptoms. Sanofi and Regeneron indicated that detailed results from the trials will be submitted for presentation at future medical meetings, and will form part of regulatory submissions.

Dupixent, which blocks the IL-4 and IL-13 signalling pathways, is currently approved in the US, Europe and a number of other countries for the treatment of adults with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable. In addition, filings seeking clearance of Dupixent for the treatment of certain adults and adolescents with inadequately controlled moderate-to-severe asthma are currently under review, with the FDA set to make a decision on a marketing application by October 20.

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