New lung cancer trial data revealed at ESMO Asia 2017

AstraZeneca presented new data from a subgroup analysis of the Phase III FLAURA trial, which explored Tagrisso (osimertinib) as 1st-line therapy in patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC). Results showed that patients with central nervous system (CNS) metastases at baseline had a higher objective response rate with their brain metastasis and suggest a lower risk of CNS progression when treated with osimertinib, a third-generation, irreversible EGFR tyrosine kinase inhibitor (TKI), versus current standard-of-care EGFR-TKIs (erlotinib or gefitinib).

In this pre-specified subgroup analysis, osimertinib demonstrated a nominally statistically significant improvement in CNS progression-free survival (PFS) compared with current standard of care, reducing the risk of CNS disease progression or death by more than half. In addition, fewer patients in the osimertinib arm experienced disease progression due to the development of new CNS lesions, compared with patients in the comparator arm (12% vs. 30%). The CNS objective response rate (a measurement of tumour shrinkage) was also higher in patients treated with osimertinib at 66% vs. 43% for patients in the comparator arm.

The analysis included patients with at least 1 measurable and/or non-measurable CNS lesion present on baseline scan (as assessed by blinded independent central review), accounting for 23% of the total FLAURA patient population (128 of 556 patients; 61 patients enrolled in the osimertinib arm and 67 patients in the comparator arm). The FLAURA safety data for osimertinib were in line with those observed in prior clinical trials. Data were presented at the ESMO Asia 2017 Congress in Singapore.