AstraZeneca (AZN.L,AZN) Tuesday announced that Tagrisso (osimertinib) Phase III ADAURA trial will be unblinded early after overwhelming efficacy in the adjuvant treatment of patients with EGFR-mutated lung cancer. The company noted that its plans for regulatory submission are already underway.
Separately, AstraZeneca said it will initiate a randomised, global clinical trial to assess the potential of Calquence (acalabrutinib) in the treatment of the exaggerated immune response or cytokine storm associated with COVID-19 infection in severely ill patients.
Regarding Tagrisso trial, the company noted that the ADAURA trial for Tagrisso (osimertinib) in the adjuvant treatment of patients with Stage IB, II and IIIA epidermal growth factor receptor-mutated non-small cell lung cancer with complete tumour resection will be unblinded early. The decision follows a recommendation from an Independent Data Monitoring Committee based on its determination of overwhelming efficacy.
ADAURA is the first global trial for an EGFR inhibitor to show statistically significant and clinically meaningful benefit in adjuvant treatment of lung cancer.
Tagrisso (osimertinib) is a third-generation, irreversible EGFR-TKI designed to inhibit both EGFR-sensitising and EGFR T790M-resistance mutations, with clinical activity against CNS metastases.
The primary endpoint of the Phase III ADAURA trial is disease-free survival. 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.
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