Tezepelumab is the first biologic to consistently and significantly reduce exacerbations in a broad population of severe asthma patients.- AstraZeneca + Amgen

Positive full results from the pivotal NAVIGATOR Phase III trial showed AstraZeneca and Amgen’s tezepelumab demonstrated a statistically significant and clinically meaningful reduction in the annualised asthma exacerbation rate (AAER) in severe, uncontrolled asthma patients . The results were presented at the American Academy of Asthma Allergy & Immunology Virtual Annual Meeting. Tezepelumab, a potential first-in-class medicine, when added to standard of care (SoC) achieved a 56% reduction (p<0.001) in aaer over 52 weeks in the overall patient population, compared to placebo when added to soc. soc was medium- or high-dose inhaled corticosteroids (ics) plus at least one additional controller medication with or without oral corticosteroids (ocs). tezepelumab is the only biologic medicine to consistently and significantly reduce aaer in a broad population of severe asthma patients irrespective of baseline eosinophil count across phase ii and phase iii clinical trials. in a pre-planned subgroup analysis tezepelumab achieved a statistically significant and clinically meaningful 41% reduction (p><0.001) in aaer in patients with baseline eosinophil counts less than 300 cells per microlitre. importantly, clinically meaningful reductions in aaer were also observed in two additional subgroups: 39% in patients with baseline eosinophil counts less than 150 cells per microlitre and 70% in patients with greater than or equal to 300 cells per microlitre. additionally, clinically meaningful reductions in aaer compared to placebo were observed in the tezepelumab-treated patients irrespective of allergy status and fractional exhaled nitric oxide (feno) level, biomarkers used by clinicians to inform treatment options. professor andrew menzies-gow, director of the lung division, royal brompton hospital, london, uk, and principal investigator of the navigator phase iii trial, said: “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. tezepelumab has the potential to transform treatment for a broad population of patients with severe asthma regardless of their type of inflammation, including those with and without an eosinophilic phenotype.” t here were no clinically meaningful differences in safety results between the tezepelumab and placebo groups. the most frequently reported adverse events were nasopharyngitis, upper respiratory tract infection and headache. navigator is a pivotal phase iii trial that will form the basis of regulatory submission. tezepelumab blocks the action of thymic stromal lymphopoietin (tslp), an epithelial cytokine that plays a key role across the spectrum of asthma inflammation. navigator is the first phase iii trial to show benefit in severe asthma by targeting tslp. see-menzies-gow a, corre j, bourdin a, et al. "efficacy and safety of tezepelumab in adults and adolescents with severe, uncontrolled asthma: results from the phase iii navigator study ". l 46. aaaai poster. february 2021.>