Benralizumab: Phase IIb data

A double-blind, international Phase IIb trial in 606 patients with uncontrolled asthma and elevated baseline blood eosinophil levels showed that 100 mg subcutaneous benralizumab met the primary endpoint of reducing annual exacerbation rate at week 52 in eosinophil-positive patients (n=82) vs. placebo (n=80; 0.34 vs. 0.57, p=0.096). The threshold for significance was p<0.2, but after an interim analysis the threshold was adjusted to p<0.169. Benralizumab missed the primary endpoint at the 2 mg dose (0.65, p=0.781) and 20 mg dose (0.37, p=0.173) vs. placebo. In eosinophil-negative patients, 100 mg benralizumab led to an annual exacerbation rate of 0.43 vs. 0.56 for placebo (p=0.284). All 3 doses of benralizumab met the secondary endpoint of improving FEV1 from baseline to week 52 vs. placebo. A pre-specified subgroup analysis showed that the higher the baseline eosinophil count, the greater the response to benralizumab for both exacerbation rate and change from baseline in FEV1. The most common adverse events reported were nasopharyngitis, headache, upper respiratory tract infection, bronchitis, pharyngitis and influenza. Data were presented at the American Thoracic Society meeting in San Diego. ...