Osimertinib demonstrated clinical activity, with a manageable safety profile, among patients with EGFR T790M mutation-positive non-small cell lung cancer (NSCLC) who had disease progression with an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, according to study findings published in The Lancet Oncology.1

Osimertinib is an oral, potent, irreversible EGFR kinase inhibitor approved by the U.S. Food and Drug Administration for the treatment of patients with metastatic EGFR T790M mutation-positive NSCLC. Approval was based on preliminary data from the phase 2 AURA extension and AURA2 trials.

For the single-arm, open-label, AURA2 study (ClinicalTrials.gov Identifier: NCT02094261), investigators enrolled 199 patients with centrally confirmed EGFR T790M-positive locally advanced or metastatic NSCLC who progressed on previous EGFR kinase inhibitor therapy. All patients received osimertinib orally once daily until disease progression or unacceptable toxicity; patients were eligible to continue osimertinib beyond progression if the investigator observed a clinical benefit.

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At a median follow-up of 13.0 months, 70% (95% CI, 64-77) achieved an objective response per blinded independent central review, with 3% achieving complete responses and 67% having partial responses.

The most common grade 3 to 4 adverse events were embolism, QT interval prolongation, neutropenia, anemia, dyspnea, hyponatremia, elevated alanine transaminase (ALT), and thrombocytopenia.

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One-quarter of patients experienced serious adverse events, of which 5% were deemed potentially related to osimertinib treatment. One patient died due possibly treatment-related interstitial lung disease.

The findings support the use of osimertinib in patients with EGFR T790M mutation-positive disease who have progressed on prior therapy with an EGFR kinase inhibitor.              


  1. Goss G, Tsai C-M, Shepherd FA, et al. Osimertinib for pretreated EGFR Thr790Met-positive advanced non-small-cell lung cancer (AURA2): a multicentre, open-label, single-arm, phase 2 study. Lancet Oncol. 2016 Oct 14. doi: 10.1016/S1470-2045(16)30508-3 [Epub ahead of print]