Data in the first-line setting demonstrated that in 60 patients who received AZD9291 once daily 72% (95% confidence interval (CI) 58% to 82%) were progression free (PFS) at 12 months. Confirmed overall response rate (ORR) was 75% (95% CI 62% to 85%). The longest duration of response (DoR) was ongoing at 18 months.
Data on two AURA Phase II studies (AURA extension and AURA2) in previously treated patients with EGFR T790M mutation were also presented. While still preliminary, these studies showed an efficacy and tolerability profile for AZD9291 consistent with previously reported data. In AURA extension (n=201), ORR was 61% (95% CI 54% to 68%); median DoR and median PFS were not calculable (NC). Consistent results were observed in AURA2 (n=210), ORR was 71% (95% CI 64% to 77%); median DoR was 7.8 months (95% CI 7.1 months to NC) and median PFS was 8.6 months (95% CI 8.3 months to 9.7 months).
The safety profile of AZD9291 in these studies was in line with that reported earlier in the year. In the AURA first-line cohort, the most common all-cause adverse events (AE) of any grade across different dose groups included rash (grouped terms) (77% all grades, 2% Grade greater-than or equal to 3) and diarrhea (73% all grades, 3% Grade greater-than or equal to 3). These AEs were also reported as the most common in the two AURA Phase II studies (AURA extension, rash 40% all grades, 1% Grade greater-than or equal to 3, diarrhea 45% all grades, 1% Grade greater-than or equal to 3; AURA 2, rash 42% all grades, 1% Grade greater-than or equal to 3, diarrhea 39% all grades, 1% Grade greater-than or equal to 3).
