The study results support the role of tezepelumab-ekko as a first-in-class treatment for a broad population of patients with severe asthma, regardless of biomarker levels.
New results from a pooled post-hoc analysis of the pivotal Phase 3 NAVIGATOR and Phase 2b PATHWAY trials showed that tezepelumab-ekko (Tezspire; Amgen) reduced the annualized asthma exacerbation rate (AAER) in biomarker subgroups of patients with severe asthma.
According to the researchers, these results support the role of tezepelumab-ekko as a first-in-class treatment for a large population of patients with severe asthma, regardless of biomarker levels. Tezepelumab-ekko is indicated for the adjunctive maintenance treatment of adult and pediatric patients 12 years of age and older with severe asthma, although it is not indicated for the relief of acute bronchospasm or asthma. of asthmatic illness.
“The majority of severe asthma patients have multiple inflammatory factors, triggered by allergens, viral and bacterial infections, and air pollution, all of which can contribute to ongoing exacerbations,” said Jonathan Corren, MD, principal investigator of the PATHWAY trial, in a press release. “These new results highlight the potential of Tezspire to reduce severe asthma exacerbations in patients, regardless of biomarker levels and seasonal triggers.”
The PATHFINDER clinical trial program included the Phase 2b PATHWAY and Phase 3 NAVIGATOR trials, as well as an oral corticosteroid-sparing trial, a mechanistic trial, and a long-term safety trial. The PATHWAY trial evaluated the efficacy and safety of 3 dosing regimens of tezepelumab-ekko, 70 mg and 210 mg every 4 weeks versus 280 mg every 2 weeks. The NAVIGATOR trial population included approximately equal proportions of patients with high and low blood eosinophils. The trial included a 5-6 week screening period, a 52 week treatment period and a 12 week post-treatment follow-up period.
In the pooled analysis, adding tezepelumab-ekko to standard of care reduced asthma exacerbations in patients regardless of baseline blood eosinophil count. This treatment has also demonstrated consistent efficacy with a 71% (≥300 cells per microliter), 48% (
In the same data analysis, treatment with tezepelumab-ekko also resulted in improvements in AAER in patients regardless of fractional exhaled nitric oxide (FeNO) levels and allergic status over 52 weeks, compared to to the placebo.
Additionally, in a predefined NAVIGATOR exploratory analysis, tezepelumab-ekko demonstrated consistent efficacy throughout the year, regardless of season. Study data revealed that the treatment reduced AAER by 63% in winter, 46% in spring, 62% in summer, and 52% in fall compared to placebo. Across seasons, the proportion of patients with an exacerbation was lower in the tezepelumab-ekko group than in the placebo group, according to study data.
“We are excited to continue to see patients experience fewer asthma attacks after treatment with Tezspire based on the results of the latest analyzes from the NAVIGATOR and PATHWAY trials,” said David M. Reese, MD, Executive Vice President of research and development at Amgen, in the press release. “These results further reinforce our belief that Tezspire has the potential to be a transformative medicine for people with severe asthma, regardless of the season or their specific type of severe asthma.”
New data further support the efficacy of Tezspire (Tezepelumab-ekko) in a large population of patients with severe asthma. Press release. Amgen; February 26, 2022. Accessed March 1, 2022. https://wwwext.amgen.com/newsroom/press-releases/2022/02/new-data-further-reinforce-efficacy-of-tezspire-tezepelumabekko-in-a- large-population-of-severe-asthmatic-patients