What is the role of osimertinib in the treatment of non–small cell lung cancer (NSCLC)?

Updated: Jun 05, 2020
  • Author: Winston W Tan, MD, FACP; Chief Editor: Nagla Abdel Karim, MD, PhD  more...
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Answer

Osimertinib is a kinase inhibitor of EGFR that binds irreversibly to certain mutant forms of EGFR (T790M, L858R, and exon 19 deletion). It was approved in November 2015 for metastatic EGFR T790M mutation–positive NSCLC, as detected by an FDA-approved test, in patients who have progressed on or after EGFR TKI therapy. Approval was based on data from two AURA phase II studies (AURA extension and AURA2), which demonstrated efficacy in 411 patients whose disease had progressed on or after an EGFR TKI. In those trials, overall objective response rate (ORR) was 59% (95% CI: 54% to 64%). [188] A confirmatory phase III trial (AURA3) is ongoing.

Osimertinib appears to improve outcome in patients with leptomeningeal metastases. In addition, in a phase III trial, osimertinib showed efficacy superior to that of standard EGFR-TKIs in the first-line treatment of EGFR mutation-positive advanced NSCLC, with a similar safety profile and lower rates of serious adverse events. [166]


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