CPhI Online

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AstraZeneca "incredibly excited" by lung cancer treatment trial

13 Apr 2020

Independent Data Monitoring Committee (IDMC) recommends unblind Phase III trial of Tagrisso 2 years ahead of schedule.

AstraZeneca has cause for celebration after the Phase III trial for Tagrisso (osimertinib) in the adjuvant treatment of postsurgery patients with epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) will be unblinded early following a recommendation from an IDMC based on its determination of overwhelming efficacy.

In a Phase III trial named ADAURA, Tagrisso was pitted against placebo for a treatment duration of up to 3 years, during which investigators measured disease-free survival (DFS).

José Baselga, AstraZeneca's Executive Vice President, Oncology R&D said they were "incredibly excited with the unprecedented results" in patients with early-stage EGFRm NSCLC.

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.

José Baselga said: "We are thrilled by the recommendation to unblind the Phase III ADAURA trial much earlier than expected. Lung cancer is a devastating diagnosis and for the first time an EGFR-targeted medicine can now provide the hope of cure."

The company has said it will present the data at a forthcoming medical meeting.

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