Tezepelumab Reduces Exacerbations in Severe, Uncontrolled Asthma

Jennifer Barrett

Jennifer Barrett is the senior editor for Drug Topics® and Total Pharmacy®.

New data from a phase 3 clinical trial demonstrated promising results for tezepelumab in adults and adolescents with severe asthma.

Tezepelumab, an investigational therapy being evaluated in patients with severe asthma, demonstrated positive results in a recent phase 3 study.

New findings from the NAVIGATOR phase 3 trial were published in the New England Journal of Medicine and presented at the American Thoracic Society (ATC) 2021 International Conference.1,2

The study included 1061 patients aged 12 to 80 years who were randomly assigned to receive either tezepelumab (210 mg) or placebo subcutaneously every 4 weeks over a 52-week period. The primary end point was annualized asthma exacerbation rates (AEERs) over the study period. Tezepelumab, a human monoclonal antibody, blocks thymic stromal lymphopoietin, an epithelial-cell–derived cytokine implicated in the pathogenesis of asthma.1

Key Points1

  • Tezepelumab-treated patients demonstrated reductions in AAERs; AAER was 0.93 (95% CI, 0.80 to 1.07) with tezepelumab and 2.10 (95% CI, 1.84 to 2.39) with placebo (rate ratio, 0.44; 95% CI, 0.37 to 0.53; P<0.001).
  • Patients with elevated blood eosinophil counts (≥300 cells per microliter) and fractional exhaled nitric oxide (FeNO) levels (≥25 parts per billion) who were treated with tezepelumab achieved a clinically meaningful 77% reduction in the AAER, compared with placebo.
  • At week 52, tezepelumab-treated patients exhibited greater improvements compared with those treated with placebo, with respect to the prebronchodilator forced expiratory volume in 1 second (FEV1) and Asthma Control Questionnaire-6 and Asthma Symptom Diary scores.

Previous data from NAVIGATOR were presented in February 2021. Those findings showed a statistically significant and clinically meaningful reduction in the primary end point of AAER over 52 weeks in the overall patient population. Additionally, clinically meaningful reductions in AAER compared with placebo were observed in patients treated with tezepelumab irrespective of blood eosinophil counts, allergy status, or FeNO level.2

“Managing severe asthma is challenging with multiple inflammatory pathways often contributing to the complexity of a patient’s disease,” said principal investigator professor Andrew Menzies-Gow, director of the Lung Division, Royal Brompton Hospital, London, United Kingdom, in a statement.2 “These latest results underscore the potential of Tezepelumab to transform treatment for a broad population of severe asthma patients regardless of their type of inflammation.”

Further results from the tezepelumab PATHFINDER clinical trial program were also presented during the ATS conference, including the primary analyses from the SOURCE phase 3 and CASCADE phase 3 trials.2


  1. Menzies-Gow A, Corren J, Bourdin A, Chupp G, et al. Tezepelumab in adults and adolescents with severe, uncontrolled asthma. The New England Journal of Medicine. May 13, 2021. Doi: 10.1056/NEJMoa2034975
  2. New Tezepelumab Data Continue To Strengthen Profile For A Broad Population Of Severe Asthma Patients. News Release. Amgen; May 13, 2021. Accessed May 24, 2021. https://www.amgen.com/newsroom/press-releases/2021/05/new-tezepelumab-data-continue-to-strengthen-profile-for-a-broad-population-of-severe-asthma-patients