Positive results with AZD 9291 in NSCLC presented at ASCO - AstraZeneca

Data from the ongoing Phase I AURA study in patients with epidermal growth factor receptor mutation positive (EGFRm+), advanced Non-Small Cell Lung Cancer (NSCLC), demonstrate that following treatment with the investigational drug AZD 9291, from AstraZeneca, the overall disease control rate was 94 percent for patients with EGFR T790M+ tumours, meaning that their tumours shrank or became stable. Results from the AURA study show that, amongst the 205 evaluable patients, the overall response rate (ORR) was 53 percent (unconfirmed + confirmed). The ORR was higher (64 percent confirmed and unconfirmed) in the 107 evaluable patients whose tumours were T790M+ compared to the 50 patients whose tumours were T790M- (22 percent confirmed and unconfirmed).

In total, 94 percent (101/107) of patients whose tumours were T790M+ had their tumours shrink or become stable. The most common AEs, reported in at least 10 percent of patients regardless of dose and mostly Grade 1 or 2, were: diarrhoea, rash and nausea. The development programme for AZD9291 includes AURA Phase II (the expansion portion of the current AURA Phase I/II study), AURA 2 (a separate Phase II) and a Phase III study. The Phase III study in patients with T790M+ NSCLC is planned to commence later this year. The company anticipates filing for regulatory approval in the United States for AZD9291 in the second half of 2015 or potentially as early as the first quarter. Data were presented at ASCO.