Astra Zeneca reports results of AZD 9291 in AURA trial for EGFRm NSCLC T790 mutation.

AstraZeneca has announced latest data from the ongoing AURA study of AZD 9291 in patients with advanced epidermal growth factor receptor mutation positive (EGFRm) non-small cell lung cancer (NSCLC), who also have the T790M resistance mutation. The data demonstrated a median progression free survival (PFS) of 13.5 months (95% confidence interval (CI) 8.3 months to not calculable (NC)). These PFS findings relate to independently reviewed data from 63 patients with T790M tumours treated with AZD 9291 at a dose of 80mg per day, and are based on only 38% of patients having tumour progression. The updated data also show an overall response rate with AZD 9291 80mg of 54% (95% CI 41% to 67%) and a median duration of response of 12.4 months (95% CI 8.3 months to NC).

Comment: AZD 9291 had breakthrough therapy designation at the FDA for patients with metastatic EGFR T 790M mutation .

Comment: AstraZeneca competes with Clovis Oncology with its CO 1686 drug with its latest 57% response rate, to be first to file in the US for this condition.

Comment: Astra Zeneca is combining with Roche to devise a diagnostic test for the EGFR T 790 mutation to negate teh need for repeat biopsies. There are no treatments approved for the EGFR 790 mutation of NSCLC.