Study findings support the role of tezepelumab-ekko as a first-in-class treatment for a broad population of patients living with severe asthma, irrespective of biomarker levels.
New results from a pooled post-hoc analysis of the pivotal NAVIGATOR phase 3 and PATHWAY phase 2b trials showed that tezepelumab-ekko (Tezspire; Amgen) reduced the annualized asthma exacerbation rate (AAER) across biomarker subgroups of patients with severe asthma.
According to the investigators, these findings support the role of tezepelumab-ekko as a first-in-class treatment for a broad population of patients living with severe asthma, irrespective of biomarker levels. Tezepelumab-ekko is indicated for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma, although it is not indicated for the relief of acute bronchospasm or status asthmaticus.
“The majority of severe asthma patients have multiple drivers of inflammation, 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 Tezspire’s potential to reduce severe asthma exacerbations in patients irrespective of biomarker levels and seasonal triggers.”
The PATHFINDER clinical trial program included the phase 2b PATHWAY and the 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 dose 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 eosinophil counts. The trial was comprised of a 5- to 6-week screening period, a 52-week treatment period, and a 12-week post-treatment follow-up period.
In the pooled analysis, the addition of tezepelumab-ekko to standard of care reduced asthma exacerbations in patients irrespective of baseline blood eosinophil counts. This treatment also demonstrated consistent efficacy with a 71% (≥300 cells per microliter), 48% (<300 cells per microliter), and 48% (<150 cells per microliter) reduction in the AAER over 52 weeks, compared to treatment with placebo and standard of care.
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 allergy status over 52 weeks, compared to placebo.
Furthermore, in a pre-specified exploratory analysis from NAVIGATOR, tezepelumab-ekko demonstrated consistent efficacy throughout the year regardless of the season. Study data found that the treatment reduced the AAER by 63% in the winter, 46% in the spring, 62% in the summer, and 54% in the fall compared to placebo. Across all seasons, the proportion of patients with an exacerbation was lower in the tezepelumab-ekko group than in the placebo group, according to the study data.
“We’re thrilled to continue seeing patients experience fewer asthma attacks following treatment with Tezspire based on results from the latest analyses in 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 strengthen our belief that Tezspire has the potential to be a transformative medicine for people living with severe asthma regardless of the season or their specific type of severe asthma.”
New Data Further Reinforce Efficacy of Tezspire (Tezepelumab-ekko) in a Broad Population of Severe Asthma Patients. News 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-broad-population-of-severe-asthma-patients