Tagrisso拿下术后辅助

ADAURA is the first global trial for an EGFR inhibitor to show statistically significant and clinically meaningful benefit in adjuvant treatment of lung cancer

Plans for regulatory submission already underway

ADAURA是首个在肺癌的术后辅助中中证明了EGFR抑制剂有着显著差异和临床获益的研究，计划向监管机构提交上市申请。

在ADAURA临床3期研究旨在对比Tagrisso对比安慰剂用于EGFR敏感突变的IB-IIIA期NSCLC患者在肿瘤完整切除后的辅助治疗，一旦IDMC发现了疗效diao爆了随即进入揭盲状态。

入组标准：Ex19del 或L858R之一 ，可以同时携带T790M突变

主要终点DFS

次要终点

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The ADAURA Phase III trial for Tagrisso (osimertinib) in the adjuvant treatment of patients with Stage IB, II and IIIA epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) with complete tumour resection will be unblinded early following a recommendation from an Independent Data Monitoring Committee (IDMC) based on its determination of overwhelming efficacy.

José Baselga, Executive Vice President, Oncology R&D, said: "We are thrilled by the recommendation to unblind the Phase III ADAURA trial much earlier than expected and are incredibly excited with these unprecedented results in patients with early-stage EGFR-mutated non-small cell lung cancer. Lung cancer is a devastating diagnosis and for the first time an EGFR-targeted medicine can now provide the hope of cure."

The primary endpoint of the Phase III ADAURA trial is disease-free survival (DFS). Tagrisso was assessed against placebo for a treatment duration of up to three years. The trial will continue to assess the secondary endpoint of overall survival. In its communication to AstraZeneca, the IDMC did not raise any new safety concerns. The data will be presented at a forthcoming medical meeting.