Phase III SYNAPSE study of Nucala meets endpoints in chronic rhinosinusitis with nasal polyps.- GlaxoSmithKline

GlaxoSmithKline announced positive results from the pivotal phase III SYNAPSE study of Nucala (mepolizumab) in patients suffering from chronic rhinosinusitis with nasal polyps (CRSwNP). This is the first time an anti-IL5 biologic has reported positive phase III data in CRSwNP, and adds to the range of eosinophil-driven diseases in which Nucala has efficacious data. SYNAPSE is the first study to evaluate the benefit of biologic treatment for patients all of whom had a history of previous surgery (approximately one in three had at least 3 surgeries) and were in need of further surgery due to severe symptoms and increased size of their polyps.

The study met both co-primary endpoints, with mepolizumab, added to standard of care, 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 49-52, compared to placebo added to standard of care. It showed a difference in median change from baseline for total endoscopic nasal polyps score: -0.73 (95% CI: -1.11, -0.34), and a difference in median change from baseline for nasal obstruction visual analogue scale score: -3.14 (95% CI: -4.09, -2.18). The key secondary endpoint of time to first actual nasal surgery up to week 52 was also statistically significant, with mepolizumab, added to standard of care, showing a reduction of 57% (p=0.003) versus placebo added to standard of care (hazard ratio [95% CI]: 0.43 [0.25, 0.76]). The safety results in the study were consistent with the known profile of mepolizumab. Based on these data, GSK plans to progress regulatory submissions in 2020.