Lugogo N, et al. Breakthroughs in Pediatric and Adult Asthma Clinical Trials. Presented at: American Thoracic Society International Conference; May 13-18, 2022; San Francisco (hybrid meeting).
Disclosures: This study was supported by Amgen and AstraZeneca. Lugogo reports receiving consultant fees from Amgen, AstraZeneca, Genentech, GlaxoSmithKline, Novartis, Regeneron, Sanofi and Teva; received honoraria from AstraZeneca and GlaxoSmithKline; received travel support from AstraZeneca; and received research support from Amgen , AstraZeneca, Avillion, Genentech, GlaxoSmithKline, Gossamer Bio, Regeneron, Sanofi and Teva.
SAN FRANCISCO — A higher proportion of patients with severe, uncontrolled asthma treated with tezepelumab achieved on-treatment clinical response compared with patients treated with placebo, according to a new NAVIGATOR study analysis.
Nearly half of patients achieved complete response to treatment across measures of asthma exacerbation reduction, asthma control, lung function and clinician assessment, Njira L. Lugogo, MD, associate professor of internal medicine, medical director of the Michigan Clinical Research Unit and director of the asthma program in the division of pulmonary and critical care medicine at University of Michigan, and colleagues reported at the American Thoracic Society International Conference.
Healio previously reported results from NAVIGATOR, a phase 3, multicenter, randomized, double-blind, placebo-controlled study of patients aged 12 to 80 years with severe, uncontrolled asthma. Participants were randomly assigned to tezepelumab 210 mg or placebo and were followed for 52 weeks. In the overall study, tezepelumab (Tezspire, Amgen/AstraZeneca) — a human monoclonal antibody that targets thymic stromal lymphopoietin — significantly improved exacerbations, lung function, asthma control and health-related quality of life compared with placebo.
Lugogo presented results of a prespecified on-treatment analysis of clinical responses in the NAVIGATOR study. The analysis included 471 patients who received tezepelumab and 449 patients who received placebo and completed the on-treatment period.
Treatment response was defined as a reduction in exacerbations of at least 50% compared with the previous year; improvement in Asthma Control Questionnaire (ACQ)-6 score of at least 0.5; improvement in prebronchodilator FEV1 of at least 100 mL or at least 5%; and a Clinical Global Impression of Change score of minimally improved, much improved or very much improved. Participants who met all four criteria were considered complete responders.
In the on-treatment population, the proportion of patients meeting clinical response criteria were higher with tezepelumab compared with placebo at 52 weeks: ACQ-6 total score (OR = 1.99; 95% CI, 1.38-2.87), achieving lung function changes based on prebronchodilator FEV1 (OR = 1.52; 95% CI, 1.15-2.01), achieving exacerbation outcomes (OR = 2.73; 95% CI, 1.98-3.77) and achieving clinician-related response to therapy outcomes (OR = 2.25; 95% CI, 1.61- 3.14). Forty-six percent of patients assigned tezepelumab were considered complete responders compared with 24% assigned placebo (OR = 2.83; 95% CI, 2.1-3.82).
In the intent-to-treat population, the proportion of patients meeting clinical response criteria were also higher with tezepelumab at 52 weeks: ACQ-6 total score (OR = 1.82; 95% CI, 1.38-2.4), achieving lung function changes based on prebronchodilator FEV1 (OR = 1.64; 95% CI, 1.28-2.09), achieving exacerbation outcomes (OR = 2.46; 95% CI, 1.86-3.27) and achieving clinician-related response to therapy outcomes (OR = 2.07; 95% CI, 1.59- 2.71). Forty percent of patients assigned tezepelumab were considered complete responders compared with 20% assigned placebo (OR = 2.76; 95% CI, 2.09-3.65).
“These data further support the efficacy of tezepelumab in a broad population of patients with severe, uncontrolled asthma,” Lugogo said.