Osimertinib confers a high overall response rate and encouraging progression-free survival among patients with T790M-positive, advanced non-small cell lung cancer (NSCLC) who progress after epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) treatment, according to a study published in the Journal of Clinical Oncology.1

The phase 2 extension component of the multicenter, open-label, phase 1/2 AURA trial (ClinicalTrials.gov Identifier: NCT01802632) enrolled 201 patients with EGFR-TKI-pretreated T790M mutation-positive NSCLC, including those with asymptomatic, stable central nervous system metastases that did not require corticosteroids. All participants received oral osimertinib at a dose of 80 mg once daily.

Results showed that 62% (95% CI, 54-68) of the 198 evaluable patients achieved an objective response with a median duration of response of 15.2 months (95% CI, 11.3-not calculable) in responding patients. Ninety percent (95% CI, 85-94) achieved disease control.

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Median progression-free survival was 12.3 months (95% CI, 9.5-13.8). Those who received osimertinib as second-line and third-line or more had a median progression-free survival of 11.0 months (95% CI, 6.7-not calculable) and 12.4 months (95% CI, 9.5-15.5), respectively. Median overall survival was not reached (95% CI, 16.4-not calculable).

The most common adverse events potentially related to osimertinib were diarrhea in 43% and rash in 40%. Eight patients developed interstitial lung disease, including 3 fatal cases.

RELATED: NSCLC: No Overall Survival Difference Between Afatinib and Gefitinib

Osimertinib is an irreversible EGFR-TKI selective for both EGFR-TKI sensitizing mutations and T790M resistance mutations. It is approved by the U.S. Food and Drug Administration for the treatment of patients with metastatic EGFR T790M mutation-positive NSCLC who progress on or after EGFR-TKI therapy.


  1. Yang JC, Ahn MJ, Kim DW, et al. Osimertinib in pretreated T790M-positive advanced non–small-cell lung cancer: AURA study phase II extension component. J Clin Oncol. 2017 Feb 21. doi: 10.1200/JCO.2016.70.3223 [Epub ahead of print]