The late-stage trial met both the co-primary endpoints, with Nucala added to standard of care delivering statistically significant improvements in the size of nasal polyps at week 52 and also in nasal obstruction during weeks 49-52. The GSK anti-IL5 biologic was compared to placebo added to standard of care in the SYNAPSE trial.
Furthermore, the time to first actual nasal surgery up to week 52, which is the key secondary endpoint of the trial, was also significant statistically. Nucala, added to standard of care, showed a reduction of 57% compared to placebo added to standard of care.
Based on the data from the SYNAPSE trial, GSK will look to move ahead with regulatory submissions in 2020.
According to GSK, this is the first time for an anti-IL5 biologic to generate positive phase 3 data in CRSwNP. The company said that the trial results adds to the various eosinophil-driven diseases in which the drug has efficacious data.
GSK chief scientific officer and R&D president Hal Barron said: “Nasal polyps are a common condition impacting many activities that most people take for granted, such as sleeping, breathing and having a sense of smell and taste. These results show that Nucala can reduce symptoms and need for surgery in patients with nasal polyps, and we look forward to progressing this regulatory submission.”
SYNAPSE is the first trial to have assessed the benefit of biologic treatment for patients who all had a history of previous surgery and needed further surgery because of severe symptoms and increased size of their polyps, said GSK.
The phase 3 trial evaluated the efficacy and safety of the liquid formulation of Nucala 100mg added to standard of care in comparison to placebo added to standard of care in more than 400 adult patients having recurrent severe bilateral nasal polyps.
Mepolizumab, which was approved in 2015 for severe eosinophilic asthma (SEA), is a monoclonal antibody that targets IL-5. By stopping IL-5 from binding to its receptor on the surface of eosinophils, the drug reduces blood eosinophils to normal level, said GSK.