NAVIGATOR trial: Tezepelumab improves multiple asthma symptoms
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In patients with severe and uncontrolled asthma, tezepelumab reduced exacerbations regardless of initial blood eosinophil count, improved lung function, provided asthma control and enhanced users’ health-related quality of life, data show.
The phase 3 data were published in an online supplement to The Journal of Allergy and Clinical Immunology on Feb. 1 and presented during the American Academy of Allergy, Asthma and Immunology Virtual Annual Meeting, held virtually.
Tezepelumab is a human monoclonal antibody being developed by AstraZeneca and manufactured by Amgen that targets thymic stromal lymphopoietin, or TSLP, according to Andrew Menzies‐Gow, BSc, MBBS, PhD, FRCP, director of the lung division and deputy medical director of Royal Brompton and Harefield Hospitals in London, England.
Menzies-Gow and colleagues randomly assigned 1,061 patients aged 12 to 80 years from multiple centers in an approximate 1:1 ratio to receive either 210 mg of tezepelumab subcutaneously or placebo every 4 weeks for 52 weeks.
According to the researchers, tezepelumab reduced the annual asthma exacerbation rate vs. placebo by 56% (95% CI, 47-63) in the entire trial population; by 70% (95% CI, 60-78) in patients with baseline blood eosinophil counts of 300 cells/mL or more; by 41% (95% CI, 25-54) in patients with baseline blood eosinophil counts of less than 300 cells/mL; and by 39% (95% CI, 12-58) in patients with baseline blood eosinophil counts of less than 150 cells/mL.
In addition, tezepelumab significantly improved Asthma Control Questionnaire-6, Asthma Control Questionnaire-12 and FEV1 scores vs. placebo over 52 weeks (P < 0.001 for all). The investigators did not discuss specific adverse events, but reported that “safety findings were similar between treatments.”
“The results of the NAVIGATOR study are very important for the many patients with severe asthma who continue to be poorly controlled despite receiving standard of care asthma therapies,” Menzies-Gow told Healio Primary Care. “By targeting upstream inflammation mediated by TSLP, tezepelumab has the potential to improve asthma outcomes for a broad population of patients with severe asthma regardless of their inflammatory phenotype.”
Tezepelumab was granted FDA breakthrough therapy designation in 2018 for patients with severe asthma without an eosinophilic phenotype. Additional trials investigating tezepelumab are ongoing, including a long‐term extension study known as DESTINATION, according to Menzies-Gow.
Perspective
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Sumita B. Khatri, MD, MS, FCCP
Asthma symptoms arise from various reasons and determining what makes an individual’s asthma become uncontrolled is essential.
The best way to manage asthma is to reduce triggers and manage the inflammation that occurs. Recently, we have seen a broad range of biologics that help reduce inflammation from various pathophysiologic causes. We have biologics for allergy‐related asthma and biologics for eosinophilic asthma. However, for other subtypes of severe asthma, which can often require oral steroids to control, our biologic options are limited.
As a pulmonologist, I am a staunch advocate of having choices and options for patients with asthma in order to personalize and tailor their treatment plan. That is why I am enthusiastically awaiting further details on the Menzies-Gow study and willing to see how it distinguishes itself from other therapies I have currently available.
However, areas that I find important when determining whether to move forward with therapy include some of the promising results highlighted, such as how tezepelumab reduced the annual asthma exacerbation rate by 56% and how it improved patient‐reported asthma control and quality of life. Another important finding is that regardless of eosinophil levels, tezepelumab suggests a significantly improved asthma exacerbation rate, even in asthmatic individuals with fewer eosinophils. Importantly, we do not know what the exacerbation rates at the beginning and end of the trial were, and I am looking forward to reviewing those results.
We realize that patients will be satisfied and more productive in their daily lives if they feel better. My role will always be to determine what treatments will get them there.
Director, Cleveland Clinic Asthma Center
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