Tezepelumab reduces exacerbations by 86 percent in severe asthma patients: Study
USA: Tezepelumab reduced exacerbations and improved lung function and nasal symptoms in patients with severe, uncontrolled asthma and comorbid nasal polyps, according to new data from the NAVIGATOR Phase 3 trial.
Tezepelumab is a potential first-in-class treatment that acts at the top of the inflammatory cascade by targeting thymic stromal lymphopoietin (TSLP), an epithelial cytokine, and has the potential to treat a broad population of patients with severe asthma. Tezepelumab is being developed by Amgen in collaboration with AstraZeneca.
Results from the exploratory analysis of the NAVIGATOR Phase 3 Trial were presented at European Respiratory Society (ERS) International Congress 2021 held from September 5-8, 2021.
The pre-specified exploratory analysis evaluated the effect of tezepelumab in NAVIGATOR patients with or without reported nasal polyps (NP+ or NP−) in the past two years. The analysis showed tezepelumab achieved an 86% reduction in the annualized asthma exacerbation rate (AAER) in NP+ patients and 52% in NP− patients over 52 weeks, compared to placebo when added to standard of care (SoC).
Tezepelumab improved lung function at week 52 in both groups of patients with an increase in pre-bronchodilator forced expiratory volume in one second (FEV1) of 0.20 L and 0.13 L versus placebo in NP+ and NP− patients, respectively. Tezepelumab also achieved a clinically relevant improvement in nasal polyp symptoms at week 52, as measured by the Sinonasal Outcome Test (SNOT-22), reducing the SNOT-22 score in NP+ patients by 9.6 points versus placebo. The adjusted mean score reductions from baseline for tezepelumab and placebo were 20.10 points and 10.55 points. The baseline mean SNOT-22 score was 49.4 and 47.8 for tezepelumab and placebo, respectively.
"This new analysis from NAVIGATOR is exciting for up to one in five severe asthma patients who have comorbid nasal polyps," said Professor Andrew Menzies-Gow, director of the Lung Division, Royal Brompton Hospital, London, UK, the principal investigator of the NAVIGATOR trial. "The analysis shows tezepelumab's ability to reduce exacerbations, improve lung function and reduce the symptoms of nasal polyps in this comorbid population who are typically more prone to asthma attacks, have an increased likelihood of airway obstruction and may have a worse quality of life."
"We're thrilled to see significant reductions in exacerbations experienced by patients with severe asthma and comorbid nasal polyps as noted within the latest analysis of NAVIGATOR data," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "These results further strengthen our confidence in tezepelumab's potential to address a significant unmet need across a broad population of patients with severe asthma, including those with comorbid nasal polyps. We look forward to bringing this potentially transformative treatment to patients soon."
There were no clinically meaningful differences in safety results between the tezepelumab and placebo groups in the NAVIGATOR trial. The most frequently reported adverse events with tezepelumab were nasopharyngitis, upper respiratory tract infection, and headache.5
Results from the NAVIGATOR Phase 3 trial were published in the New England Journal of Medicine in May 2021.5 A Phase 3 clinical trial, WAYPOINT has been initiated to explore the efficacy and safety of tezepelumab in adults with severe, chronic rhinosinusitis with nasal polyps.6
