The phase III FLAURA trial showed a statistically-significant and clinically-meaningful progression-free survival (PFS) benefit with osimertinib compared to current 1st-line standard-of-care treatment (erlotinib or gefitinib) in previously-untreated patients with locally advanced or metastatic epidermal growth factor receptor mutation-positive (EGFRm) non-small cell lung cancer (NSCLC).

The efficacy, safety and tolerability profiles for osimertinib, erlotinib and gefitinib were consistent with current knowledge.

A full evaluation of the FLAURA data is ongoing.

The primary endpoint of the trial was progression-free survival (PFS), and secondary endpoints included overall survival, objective response rate, duration of response, disease control rate, safety and measures of health-related quality of life (HRQoL).

Further results will be presented at a forthcoming medical meeting.

Osimertinib is a third generation, irreversible EGFR tyrosine kinase inhibitor (TKI) designed to inhibit both EGFR sensitising and EGFR T790M resistance mutations, with clinical activity against central nervous system (CNS) metastases.

40mg and 80mg once-daily oral tablets have been approved in more than 50 countries, including the US, EU, Japan and China, for patients with epidermal growth factor receptor (EGFR) T790M mutation-positive advanced non-small cell lung cancer (NSCLC).

Eligibility for treatment with osimertinib is dependent on confirmation that the EGFR T790M mutation is present in the tumour.

Osimertinib is also being investigated in the adjuvant and metastatic first-line settings, including in patients with and without CNS metastases, in leptomeningeal metastases, and in combination with other treatments.

Osimertinib once-daily tablets are approved for the treatment of patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test, whose disease has progressed on or after an EGFR tyrosine kinase inhibitor (TKI) therapy.

Source: BusinessWire