Tezepelumab significantly reduced exacerbations in severe asthma: NAVIGATOR trial
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AstraZeneca announced positive results from the NAVIGATOR phase 3 trial of tezepelumab, demonstrating a statistically significant and clinically meaningful reduction in exacerbations in patients with severe, uncontrolled asthma.
Tezepelumab is a potential first-in-class medicine to block thymic stromal lymphopoietin, an epithelial cytokine that plays an important role across asthma inflammation, according to a company press release.
“Today’s groundbreaking results show that tezepelumab has the potential to transform care for a broad population of severe asthma patients who are underserved today, including those without an eosinophilic phenotype,” Andrew Menzies-Gow, MD, principal investigator of the NAVIGATOR phase 3 trial and director of the lung division at Royal Brompton Hospital, London, said in the release.
In the NAVIGATOR phase 3, randomized, double-blind, placebo-controlled trial, tezepelumab plus standard of care met the primary endpoint of reduction in annualized asthma exacerbation rate over 52 weeks in adults (aged 18-80 years) and adolescents (aged 12-17 years) compared with placebo, according to the release. Patients had severe, uncontrolled asthma and were receiving treatment with medium- or high-dose inhaled corticosteroids plus a controller modification with or without oral corticosteroids.
The trial cohort included patients with high (300 cells/L or more) and low (less than 300 cells/L) blood eosinophil counts, the release stated. All participants received their prescribed controller medications without change during the trial period.
Tezepelumab was well tolerated in the cohort, and there were no clinically meaningful differences in safety results between tezepelumab and placebo.
“Building on the broad efficacy previously seen with tezepelumab, these are exciting data that bring us one step closer to delivering a medicine to severe asthma patients, including those with low eosinophil counts,” Mene Pangalos, executive vice president of biopharmaceuticals research and development for AstraZeneca, said in the release.
Tezepelumab was granted FDA breakthrough therapy designation in 2018 for patients with severe asthma without an eosinophilic phenotype. Results from the NAVIGATOR trial will be presented at a future medical meeting, according to the release.