Tezepelumab Demonstrates 86% Reduction in Exacerbations in Severe Asthma Patients with Nasal Polyps in Latest NAVIGATOR Trial Analysis

Today, Amgen announced the latest data analysis from its pivotal Phase 3 NAVIGATOR clinical trial of tezepelumab, a potential "first-in-class" antibody therapy. The analysis results showed that in patients with severe, uncontrolled asthma accompanied by nasal polyps, adding tezepelumab to standard of care reduced the exacerbation rate by 86% compared with placebo.

Tezepelumab, co-developed by Amgen and AstraZeneca, is a potential "first-in-class" drug that blocks the action of thymic stromal lymphopoietin (TSLP). TSLP is an epithelial cytokine positioned at the top of multiple inflammatory cascades, initiating excessive immune responses that drive allergic, eosinophilic, and other types of airway inflammation associated with severe asthma. Currently, its New Drug Application (NDA) has been granted Priority Review designation by the U.S. FDA and is under FDA review.

▲TSLP influences immune responses in multiple immune cells (Image source: Reference [2])

Prespecified exploratory analysis showed that tezepelumab reduced the annualized asthma exacerbation rate (AAER) by 86% (95% CI: 70, 93) in patients with severe asthma and nasal polyps; in patients with severe asthma without nasal polyps, the reduction was 52% (95% CI: 42, 61).

Tezepelumab improved lung function in both patient groups, increasing pre-bronchodilator forced expiratory volume in 1 second (FEV1) by 0.20 L (with nasal polyps) and 0.13 L (without nasal polyps) at Week 52. Additionally, it provided clinically meaningful improvements in nasal polyp symptoms.

References:

[1] New Tezepelumab Data Show 86% Reduction In Exacerbations In Patients With Severe Asthma And Comorbid Nasal Polyps. Retrieved September 5, 2021, from https://www.prnewswire.com/news-releases/new-tezepelumab-data-show-86-reduction-in-exacerbations-in-patients-with-severe-asthma-and-comorbid-nasal-polyps-301368866.html

[2] Comeau & Ziegler. (2009). The influence of TSLP on the allergic response. Mucosal Immunology, https://doi.org/10.1038/mi.2009.134

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