GSK's asthma biologic Nucala is one step closer to approval in key chronic rhinosinusitis population
Months after GSK’s Nucala cleared in a pivotal rare blood disorder study, the asthma biologic has scored in a late-stage trial in chronic rhinosinusitis patients with nasal polyps.
The British drugmaker on Friday disclosed data from the SYNAPSE study, which tested Nucala (also known as mepolizumab) against a placebo on top of standard-of-care in more than 400 patients, all of whom had a history of previous surgery (approximately one in three had ≥3 surgeries) and required surgery due to severe symptoms and bigger polyps.
Nucala met both the main goals demonstrating statistically significant improvements in both the size of nasal polyps (p<0.001) at week 52 and in nasal obstruction (p<0.001) during weeks 49 to 52. A key secondary endpoint, timed to first actual nasal surgery up to week 52, was also statistically significant — showing a reduction of 57% (p=0.003) versus placebo, GSK said.
“These results show mepolizumab represents a promising alternative for patients who are caught in a cycle of surgeries. Each surgery carries risks and can disable the patient for several weeks,” Claus Bachert, professor and Chief of Clinics ENT Department at Ghent University said in a statement.
GSK said it plans to submit applications to market the drug in the patient population later this year.
Chronic rhinosinusitis (CRS), characterized by inflammation of the nose and sinus cavities, is a common condition, affecting almost 12% of the global adult population. About a fifth of patients with CRS have nasal polyps, which are benign growths in the nasal cavities, according to the American Academy of Allergy, Asthma & Immunology.
First approved in 2015 for severe eosinophilic asthma, Nucala targets IL-5. The drug is believed to work by preventing IL-5 from binding to its receptor on the surface of eosinophils diminishing blood eosinophils, but not eradicating them altogether, according to GSK.
Last year, the FDA spurned GSK’s application to expand the drug’s use in patients with COPD, after it failed one late-stage test but cleared another. After an expert panel voted 16 to 3 against approval, the rejection was widely anticipated. In November, the monoclonal antibody helped patients with hypereosinophilic syndrome (HES) — a group of life-threatening inflammatory disorders characterized by a persistent overproduction of a type of white blood cell called eosinophils — in a 108-patient late-stage study.
Last year, Regeneron and Sanofi secured the first approval for chronic rhinosinusitis with nasal polyps with their flagship IL-4 and IL-13 biologic Dupixent. Novartis’ bestseller Xolair — which is engineered to immunoglobulin E — is expected to win approval in the patient population this year.