New data from the phase 3 NAVIGATOR trial demonstrate superior efficacy of tezepelumab to reduce asthma exacerbations in severe disease year round.
Adults and adolescents with severe uncontrolled asthma treated with the novel thymic stromal lymphopoietin (TSLP) inhibitor tezepelumab, experienced fewer asthma exacerbations year round, regardless of season, according to new data from the phase 3 NAVIGATOR trial announced by the American Academy of Allergy, Asthma & Immunology (AAAAI).
Tezepelumab was approved in late December 2021 by the US Food and Drug Administration (FDA) and is being marketed at Tezspire. The indication for the injectable monoclonal antibody is as an add-on maintenance treatment for severe asthma symptoms when used with a patient’s current asthma medication. Tezepelumab is the first treatment for severe asthma without biomarker or phenotype restrictions.
The multi-center, randomized, double-blind, placebo-controlled study NAVIGATOR study included 1059 patients aged 12 to 80 years. Participants were randomized 1:1 to receive either tezepelumab (528) or placebo (531) subcutaneously every 4 weeks over the course of 52 weeks.
The primary outcomes of interest to investigators were the annualized asthma exacerbation rate (AAER) as well as a number of patients without exacerbations during each season.
When compared to placebo, tezepelumab reduced the AAER by 63% in winter, 46% in spring, 62% in summer and 54% in fall. The researchers also report that patients who took tezepelumab vs placebo had fewer asthma exacerbations in winter (81.7% vs 66.6%), spring (84.3% vs 76.3%), summer (86.8% vs 73.1%) and fall (79.4% vs 66.6%). According to the AAAAI statement data from patients in the Southern Hemisphere was altered to align with Northern Hemisphere seasons for reasons of consistency.
“We know that different seasons can impact asthma severity and control,” said study primary author Flavia C. L. Hoyte, MD, associate professor and director, Allergy & Clinical Immunology Fellowship, in the department of medicine at National Jewish Health. “This promising data confirms that tezepelumab is effective not only regardless of asthma phenotype, but also regardless of the season. For patients with uncontrolled, severe asthma, it is vital to have effective medications that can improve symptoms at all times of year.”
More detailed findings from NAVIGATOR will be presented at the 2022 annual meeting of the American Academy of Allergy, Asthma & Immunology (AAAAI), February 25-28, 2022.