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  • Tagrisso data from ADAURA Phase III trial presente...

Tagrisso data from ADAURA Phase III trial presented at WCLC showed patients with epidermal growth factor receptor-mutated NSCLC (EGFR) maintained their quality of life based on patient-reported outcomes.-AstraZeneca .

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Published:30th Jan 2021
Results from an exploratory analysis of the positive ADAURA Phase III trial showed AstraZeneca’s Tagrisso (osimertinib) extended disease-free survival (DFS) in patients with epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) regardless of prior adjuvant chemotherapy treatment or stage of disease, building on the unprecedented primary DFS results for Tagrisso in the adjuvant setting announced last year. Results from ADAURA were presented during the 2020 World Conference on Lung Cancer (WCLC) hosted by the International Association for the Study of Lung Cancer (IASLC) and featured in the Press Programme. In this exploratory analysis of the overall trial population, adjuvant Tagrisso reduced the risk of disease recurrence or death by 84% in patients who had been treated with prior adjuvant chemotherapy (based on a hazard ratio [HR] of 0.16, 95% confidence interval [CI] 0.10-0.26) and by 77% in patients who had not (HR 0.23; 95% CI 0.13-0.40). DFS benefits were similar across each stage of disease. In addition, a separate exploratory post-hoc analysis of patient-reported outcomes in ADAURA showed that patients treated with Tagrisso maintained their quality of life, with no clinically meaningful differences in physical or mental health measures in the Tagrisso and placebo arms. In the ADAURA Phase III trial, chemotherapy use was balanced across the two treatment arms, with 60% of patients receiving prior adjuvant chemotherapy. In line with uptake observed in prior studies and clinical practice, younger patients (<70 years) and those with more advanced disease were more likely to have prior adjuvant chemotherapy. treatment with chemotherapy did not vary according to a patient’s performance status. the safety and tolerability of?tagrisso?was consistent with previous trials in the metastatic egfrm nsclc setting. adverse events at grade 3 or higher from all causes occurred in 20% of patients in the tagrisso arm versus 13% in the placebo arm as assessed by investigators. primary results of adaura, which were published in the new england journal of medicine in september 2020, showed adjuvant treatment with tagrisso reduced the risk of disease recurrence or death by 83% (hr 0.17; 95% ci 0.12-0.23; p><0.0001) among patients with stage ii and iiia egfrm nsclc and, as shown in a prespecified exploratory analysis, demonstrated a clinically meaningful improvement in central nervous system (cns) dfs compared to placebo.>
Condition: NSCLC / EGFR
Type: drug

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