Efficacy and Safety of Tezepelumab in Adults and Adolescents with Severe, Uncontrolled Asthma: Results from the Phase 3 NAVIGATOR Study

Tezepelumab is a human monoclonal antibody that targets thymic stromal lymphopoietin (TSLP). NAVIGATOR evaluated the efficacy and safety of tezepelumab in adults adolescents with severe, uncontrolled asthma. was phase 3, multicenter, randomized, double-blind, placebo-controlled study (NCT03347279). Patients (12-80 years old) asthma were randomized 1:1 to receive 210mg subcutaneously or placebo every 4 weeks for 52 weeks. The primary endpoint annualized exacerbation rate (AAER) over overall population. This also assessed by baseline blood eosinophil count (≥300, <300 <150 cells/μL). Key secondary endpoints included change from week forced expiratory volume 1 second (FEV1), Asthma Control Questionnaire-6 (ACQ-6) score Quality Life Questionnaire (standardized) patients aged 12 older (AQLQ[S]+12) score. assessed. Overall, 1061 (tezepelumab 210mg, n=529; placebo, n=532). reduced AAER versus 56% (95% CI, 47-63; p<0.001) population, 70% 60-78), 41% 25-54; 39% 12-58) counts ≥300, cells/μL, respectively. significantly improved FEV1 ACQ-6 AQLQ(S)+12 scores (all p<0.001). Safety findings similar between treatments. exacerbations, irrespective count, lung function, control health-related quality life broad population