Positive topline results were announced from a phase 3 trial evaluating tezepelumab (Amgen and AstraZeneca) in patients with severe asthma.

Tezepelumab is an investigational first-in-class human monoclonal antibody that works by blocking thymic stromal lymphopoietin, an epithelial cytokine that is involved in the initiation and persistence of airway inflammation. The double-blind, placebo-controlled NAVIGATOR trial included patients aged 12 to 80 years with severe, uncontrolled asthma who were receiving medium- or high-dose inhaled corticosteroid plus at least 1 additional controller medication with or without oral corticosteroid; the trial included patients with both high and low blood eosinophil counts.

Patients were randomized 1:1 to receive tezepelumab or placebo administered by subcutaneous injection. The primary end point of the study was the annualized asthma exacerbation rate during the 52-week treatment period.

Results showed that treatment with tezepelumab was associated with a statistically significant and clinically meaningful reduction in annualized asthma exacerbation rate in the overall patient population compared with placebo. Significant and clinically meaningful reductions in annualized asthma exacerbation rate were also observed in patients with baseline eosinophil counts less than 300 cells/µL and less than 150 cells/µL. Additionally, no clinically meaningful differences in safety were noted between the groups.

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“Due to the complex nature of severe asthma, many patients continue to face debilitating asthma despite receiving standard of care inhaled medicines and currently approved biologics,” said Professor Andrew Menzies-Gow, director of the Lung Division, Royal Brompton Hospital, London, UK, and principal investigator of the NAVIGATOR trial. “Today’s ground-breaking results show that tezepelumab has the potential to transform care for a broad population of severe asthma patients who are underserved today, including those without an eosinophilic phenotype.”

For more information visit amgen.com.


Tezepelumab NAVIGATOR phase 3 trial met primary endpoint of a statistically significant
and clinically meaningful reduction in exacerbations in a broad population of patients with
severe asthma. [press release]. Thousand Oaks, CA: Amgen; November 9, 2020.