NAVIGATOR data show half of patients with sev

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session: B93, Breakthrough in clinical trials of pediatric and adult asthma
Date and time: 3:25 pm PT, Monday, May 16, 2022
position: Room 3006/3008 (West Building, Level 3), Moscone Center

ATS 2022, San Francisco, California – According to a study presented at the ATS 2022 International Conference, the majority of patients with severe uncontrolled asthma showed a more significant clinical response to tezepermab than placebo. This study showed that nearly half of the enrolled patients achieved a complete response to treatment throughout the measurement of exacerbation reduction, asthma control, lung function, and clinician assessment.

This study is a pre-specified intratreatment analysis of the response to tezepermab using data from the completed Phase 3 double-blind, placebo-controlled NAVIGATOR study (NCT03347279).The result of the trial is Announced at ATS2021 It was published in a peer-reviewed medical journal.

“Overall, these results are consistent with the NAVIGATOR results reported at ATS 2021 and add an important patient-level perspective to key study results,” said Associate Professor of Internal Medicine and Medical Director of Michigan Clinical. The presenter, Dr. Njira Lugogo, said. University of Michigan Ann Arbor School of Lung and Critical Care Medicine Asthma Program Research Unit and Director. “In each measurement, recipients of tezepermab were more likely to respond. The biggest difference observed was a reduction in exacerbations. In addition, 48% of patients receiving tezepermab showed a complete response. , Achieved clinically significant improvements in all four response measurements. “

Patients with both tesepermab and placebo continued to take medium- or high-dose corticosteroid inhalers and at least one other asthma control drug during the study.

417 patients who received teseperumab and 449 patients who received placebo completed the treatment period and were included in the analysis. Overall, the proportion of respondents was higher with tezepermab than with placebo (85.4% vs. 67.5%) in terms of mitigation of exacerbations. Asthma Control Questionnaire (ACQ)-6 Total Score (86.9% vs. 76.6%); Baseline bronchodilator pre-existing improvement forced exhalation volume per second (FEV)1) (60.3% vs. 49.9%); and the Clinical Global Impression of Change (CGI-C) score (81.5% vs. 67.7%). The proportion of complete respondents (those who achieved significant improvement in all measurements) was higher in the tezepermab group than in the placebo cohort (48.2% vs. 25.3%).

Tezepermab is a biopharmacy and a treatment made from living cells.

Dr. Lugogo said: “The response to biopharmacy in asthma is heterogeneous, and the impact of biopharmacy on major asthma outcomes may vary from patient to patient. Reduce exacerbations, improve symptoms and lung function, and clinically. I was interested in determining the effect of tezepermab on the four most interesting clinical outcomes, including the treatment clinician’s impression of whether improvement had occurred. Patients with severe asthma with biopharmacy There is growing interest in defining the response of each measurement. This study identified both responses for each measurement and the response for the overall combination. “

She also stated that these results could be used for shared decision-making when discussing the initiation of tezepermab therapy. She said, “Patients are always interested in understanding potential outcomes after the start of treatment, and our results inform clinicians about the possibility of both individual and complete responses to treatment. Helps. “

This study was supported by AstraZeneca and Amgen.

Dr. Lugogo has served as an advisory board for AstraZeneca and Amgen, and as a consultant for AstraZeneca. She uses her content to give lectures hosted by AstraZeneca.

View summary

You may be interested in other newsworthy summaries of asthma treatment. Denali (Safety of albuterol in mild to moderate asthma) and Mandala (Safety of salbutamol in children and adolescents) Study.

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Kelly Malcolm

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