Amgen has reported the latest data from the pivotal Phase III NAVIGATOR clinical trial where tezepelumab reduced exacerbations and boosted lung function and nasal symptoms in severe, uncontrolled asthma and comorbid nasal polyps patients.
Being developed by Amgen in partnership with AstraZeneca , tezepelumab is a potential therapy that works at the top of the inflammatory cascade.
It acts on an epithelial cytokine called thymic stromal lymphopoietin (TSLP) and can potentially treat a wide population of severe asthma patients.
Part of the Phase III PATHFINDER programme, the NAVIGATOR trial is a randomised, double-blinded, placebo-controlled trial assessing 210mg tezepelumab over placebo.
It enrolled 1,061 adults aged 18 to 80 years and adolescents aged 12 to 17 years with severe, uncontrolled asthma.
These subjects were already receiving medium- or high-dose inhaled corticosteroids (ICS) along with a minimum of one additional controller medication with or without oral corticosteroids (OCS).
The pre-specified exploratory analysis assessed the tezepelumab’s impact on subjects with or without reported nasal polyps (NP+ or NP−) in the last two years.
Data showed that the drug plus standard of care (SoC) offered an 86% decline in the annualised asthma exacerbation rate (AAER) in NP+ patients and 52% in NP− patients, respectively, over 52 weeks.
Furthermore, tezepelumab boosted lung function in NP+ and NP− patients at week 52 with a rise in pre-bronchodilator forced expiratory volume in one second (FEV1) of 0.20L and 0.13L, respectively, versus placebo.
At week 52, tezepelumab provided a clinically significant improvement in nasal polyp symptoms, as assessed by the Sinonasal Outcome Test (SNOT-22), decreasing the SNOT-22 score in NP+ patients by 9.6 points as against placebo.
In addition, no clinically meaningful differences in safety data between the tezepelumab and placebo arm were reported, with nasopharyngitis, upper respiratory tract infection and headache being the most commonly reported adverse events.
Amgen Research and Development executive vice-president David Reese said: “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.
“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.”
In March 2021, AstraZeneca reported positive full results from the Phase III NAVIGATOR trial of tezepelumab, which showed a reduction in exacerbation rate in severe, uncontrolled asthma patients.