AZ reports detailed first-line NSCLC data from Phase III FLAURA trial of Tagrisso

AstraZeneca plc (LSE:AZN; NYSE:AZN) reported additional data from the Phase III FLAURA trial in 556 previously untreated patients with locally advanced or metastatic EGFR mutation-positive non-small cell lung cancer (NSCLC) showing that first-line treatment with once-daily 80 mg oral Tagrisso osimertinib (AZD9291) led to a median progression-free survival (PFS), the primary endpoint, of 18.9 months, vs. 10.2 months for standard of care (SOC) with Tarceva erlotinib or Iressa gefitinib (HR=0.46, 95% CI: 0.37, 0.57, p<0.0001). Median duration of response was 17.2 months for Tagrisso vs. 8.5 months for SOC. Additionally, Tagrisso led to an objective response rate (ORR) of 80% vs. 76% for SOC (p=0.2335).

Furthermore, a preliminary analysis of the secondary overall survival (OS) endpoint at 25% maturity showed an OS hazard ratio of 0.63 favoring Tagrisso (95% CI: 0.45, 0.88, p=0.0068). AZ said the p-value of 0.0068 was not below the threshold of 0.0015 required for significance at the current level of maturity. A final OS analysis is planned at a later stage. Data were presented at the European Society for Medical Oncology meeting in Madrid...