Blood eosinophil counts and FeNO levels are 2 key inflammatory biomarkers used by clinicians to inform treatment options and were defined as blood eosinophil count and FeNO.
Detailed results from the pivotal NAVIGATOR phase 3 trial for Tezepelumab, a potential first-in-class treatment, demonstrated superiority across every primary and key secondary endpoint in a broad population of patients with severe asthma compared to placebo when added to standard of care (SoC), according to a press release.
Reductions in annualized asthma exacerbation rates were observed over 52 weeks in tezepelumab-treated patients compared to placebo when added to SoC across 4 patient subgroups based on blood eosinophil count and fractional exhaled nitric oxide (FeNO) levels. Blood eosinophil counts and FeNO levels are 2 key inflammatory biomarkers used by clinicians to inform treatment options and were defined as blood eosinophil count and FeNO.
In patients with elevated baseline blood eosinophil counts and FeNO levels, tezepelumab achieved a clinically meaningful 77% reduction in the AAER compared to placebo. Further, in a separate exploratory analysis of exacerbations requiring hospitalizations, tezepelumab showed an 85% reduction over 52 weeks compared to placebo when added to SoC, according to the study.
Tezepelumab demonstrated statistically significant improvements in key secondary endpoints compared to placebo in lung function, asthma control, and health-related quality of life. Improvements were observed in tezepelumab-treated patients as early as week 2 of treatment or the first time point assessment and were sustained throughout the treatment period.
These results further support the NAVIGATOR data presented in February 2021, which showed a statistically significant and clinically meaningful reduction in the primary endpoint of AAER over 52 weeks in the overall patient population. Clinically meaningful reductions in AAER compared to placebo were observed in the tezepelumab-treated patients irrespective of blood eosinophil counts, allergy status, or FeNO level, according to the study.
"Managing severe asthma is challenging with multiple inflammatory pathways often contributing to the complexity of a patient's disease. These latest results underscore the potential of tezepelumab to transform treatment for a broad population of severe asthma patients regardless of their type of inflammation," said principal investigator of the NAVIGATOR phase 3 trial, professor Andrew Menzies-Gow, director of the Lung Division, Royal Brompton Hospital, London, UK, in the press release.
David M. Reese, MD, executive vice president of Research and Development at Amgen, noted that severe uncontrolled asthma is debilitating, with patients experiencing frequent exacerbations that lead to hospitalization.
“For this reason, we were incredibly pleased to see that patients who received tezepelumab during the trial had a reduction in both ER visits and hospitalizations," Reese said in the press release. "Advancing the science to address unmet patient needs such as these has been the driving force behind Amgen's inflammation research for more than two decades. Along with our partner AstraZeneca, we are incredibly proud of these results and tezepelumab's potential for a broad population of patients with asthma."
New Tezepelumab Data Continue To Strengthen Profile For A Broad Population Of Severe Asthma Patients. Amgen. Published May 13, 2021. Accessed May 14, 2021. https://www.amgen.com/newsroom/press-releases/2021/05/new-tezepelumab-data-continue-to-strengthen-profile-for-a-broad-population-of-severe-asthma-patients