Tezepelumab is an investigational biologic for the potential treatment of severe, uncontrolled asthma.
Tezepelumab reduced exacerbation rates in patients with severe, uncontrolled asthma, according new results from the phase 3 NAVIGATOR clinical trial.
Tezepelumab is an investigational treatment in severe asthma that blocks the action of thymic stromal lymphopoietin, an epithelial cytokine that plays a key role across the spectrum of asthma inflammation. It is the only biologic to consistently and significantly reduce annualized asthma exacerbation rate (AAER) in a broad population of patients with severe asthma, irrespective of the baseline eosinophil counts across phase 2 and phase 3 trials.
The phase 3 NAVIGATOR trial included 1061 adults and adolescents with severe, uncontrolled asthma, who were receiving treatment with medium- or high-dose inhaled corticosteroid plus at least 1 controller medication with or without oral corticosteroids.
According to the findings, tezepelumab plus standard of care demonstrated a 56% reduction (p<0.001) in annualized asthma exacerbation rate (AAER) over 52 weeks in the overall patient population, compared with placebo and standard of care. Tezepelumab also achieved a statistically significant and clinically meaningful 41% reduction (p<0.001) in AAER in a pre-specified analysis of patients with baseline eosinophil counts less than 300 cells per microliter. Clinically meaningful reductions in AAE were also observed in 2 additional subgroups: a 39% reduction in patients with baseline eosinophil counts less than 150 cells per microliter and a 70% reduction in patients with greater than or equal to 300 cells per microliter.
Investigators noted additional clinically meaningful reductions in AAER compared with placebo in tezepelumab-treated patients irrespective of allergy status and fractional exhaled nitric oxide level. Statistically significant improvements were observed in every key secondary end point as well, including lung function measurements, asthma control, and health-related quality of life.
The most frequently reported adverse events with tezeplumab in the trial were nasopharyngitis, upper respiratory tract infection, and headache.
“These are ground-breaking results for the many patients with severe asthma who continue to face debilitating symptoms despite receiving standard of care inhaled medicines and currently approved biologics,” professor Andrew Menzies-Gow, director of the lung division, Royal Brompton Hospital, London, United Kingdom, said in a statement.
1. Tezepelumab Is The First Biologic To Significantly Reduce Exacerbations In Broad Population Of Patients With Severe, Uncontrolled Asthma. News release Amgen; February 25, 2021. Accessed February 26, 2021. https://www.amgen.com/newsroom/press-releases/2021/02/tezepelumab-is-the-first-biologic-to-significantly-reduce-exacerbations-in-broad-population-of-patients-with-severe-uncontrolled-asthma