The Lancet Publishes Positive Phase 3 Trial Results of Dupixent for Chronic Rhinosinusitis with Nasal Polyps and Comorbid Asthma

Recently, Regeneron Pharmaceuticals and Sanofi announced that Dupixent (dupilumab), a blockbuster drug jointly developed by the two companies, achieved positive results in two Phase 3 clinical trials for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients. The trial results have been published in the prestigious medical journal The Lancet. The trials primarily focused on adult patients who had previously undergone surgery or received systemic corticosteroid therapy.

Chronic rhinosinusitis with nasal polyps (CRSwNP) is a chronic type 2 allergic inflammatory condition that leads to the growth of nasal polyps, obstructing the sinuses and nasal cavity, and causing severe symptoms such as nasal congestion, rhinorrhea, facial pain, and impaired sense of smell and taste. Long-standing CRSwNP significantly impacts patients’ health and quality of life. To date, standard treatment options remain very limited; patients typically require intranasal and oral corticosteroids, and even surgery, yet recurrence rates are exceedingly high. Therefore, there is an urgent need for a safe, novel therapy to help patients restore their normal quality of life.

Dupixent is a humanized monoclonal antibody that specifically inhibits the overactive signaling of interleukin-4 (IL-4) and interleukin-13 (IL-13), two key proteins considered to be the primary drivers of type 2 allergic inflammation. Dupixent is the first biologic therapy approved by the FDA for patients with chronic rhinosinusitis with nasal polyps (CRSwNP) whose symptoms are not adequately controlled. Currently, Dupixent is approved for the treatment of three indications driven by type 2 inflammation, including moderate-to-severe eczema, moderate-to-severe asthma, and CRSwNP.

The two pivotal Phase 3 trials for which data were announced are LIBERTY NP SINUS-24 and LIBERTY NP SINUS-52, enrolling a total of 724 patients. The trials demonstrated that patients who received Dupixent in combination with standard therapy of intranasal corticosteroid sprays experienced reduced nasal polyp size and significantly decreased severity of nasal congestion, meeting the identical primary endpoints in both trials. Dupixent also alleviated other symptoms of chronic rhinosinusitis and improved patients’ sense of smell.

Furthermore, analysis of a prespecified set of patient subgroups demonstrated that, compared with placebo, Dupixent reduced the need for corticosteroid use by 74% and the need for surgery by 83%. Notably, in patients with comorbid asthma, Dupixent showed improvements in lung function and control of asthma exacerbations. Dupixent also exhibited a favorable safety profile.

“The results of these two trials demonstrate that Dupixent can improve all disease metrics in patients with chronic rhinosinusitis with nasal polyps (CRSwNP),” said Dr. Claus Bachert, Professor in the Department of Otorhinolaryngology at Ghent University and the principal investigator of the trial. “For CRSwNP patients with a history of asthma, Dupixent also showed excellent efficacy in improving asthma symptoms, lung function, asthma control, and upper airway outcomes. These patients often experience a substantial burden on their daily lives due to poor disease control. The positive results with Dupixent are therefore highly significant for this patient population.”

References:

[1] The Lancet Publishes Results from Two Positive Phase 3 Trials of Dupixent® (dupilumab) in Severe Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)，Retrieved September 20, 2019, from https://www.biospace.com/article/releases/the-lancet-publishes-results-from-two-positive-phase-3-trials-of-dupixent-dupilumab-in-severe-chronic-rhinosinusitis-with-nasal-polyps-crswnp-/

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