American Academy of Allergy, Asthma & Immunology Annual Meeting

American Academy of Allergy, Asthma & Immunology Annual Meeting

Source: Menzies-Gow A, et al. Abstract L46. Presented at: American Academy of Allergy and Immunology Annual Meeting; February 26 - March 1, 2021 (virtual meeting).

Disclosures: Healio Primary Care could not confirm Menzies-Gow's relevant financial disclosures at the time of publication.
February 26, 2021
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NAVIGATOR trial: Tezepelumab improves multiple asthma symptoms

Source: Menzies-Gow A, et al. Abstract L46. Presented at: American Academy of Allergy and Immunology Annual Meeting; February 26 - March 1, 2021 (virtual meeting).

Disclosures: Healio Primary Care could not confirm Menzies-Gow's relevant financial disclosures at the time of publication.
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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.

Woman getting injection in arm
Investigators presented positive phase 3 trial results tezepelumab during the American Academy of Allergy, Asthma and Immunology Virtual Annual Meeting. Photo source: Adobe Stock.

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.

Andrew Menzies-Gow

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.