Osimertinib in Japanese patients with EGFR T790M mutation-positive advanced non-small-cell lung cancer: AURA3 trial

• Akamatsu, Hiroaki

  Third Department of Internal Medicine, Wakayama Medical University

• Katakami, Nobuyuki

  Institute of Biomedical Research and Innovation, Kobe

• Okamoto, Isamu

  Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University

• Kato, Terufumi

  Kanagawa Cardiovascular and Respiratory Center

• Kim, Young Hak

  Graduate School of Medicine, Kyoto University

• Imamura, Fumio

  Osaka International Cancer Institute

• Shinkai, Masaharu

  Yokohama City University Medical Center

• Hodge, Rachel A.

  AstraZeneca Royston

• Uchida, Hirohiko

  AstraZeneca Osaka

• Hida, Toyoaki

  Aichi Cancer Center Hospital

Abstract

Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) are the first‐line treatment for patients with EGFR mutant non‐small‐cell lung cancer (NSCLC). However, most patients become resistant to these drugs, so their disease progresses. Osimertinib, a third‐generation EGFR‐TKI that can inhibit the kinase even when the common resistance‐conferring Thr790Met (T790M) mutation is present, is a promising therapeutic option for patients whose disease has progressed after first‐line EGFR‐TKI treatment. AURA3 was a randomized (2:1), open‐label, phase III study comparing the efficacy of osimertinib (80 mg/d) with platinum‐based therapy plus pemetrexed (500 mg/m²) in 419 patients with advanced NSCLC with the EGFR T790M mutation in whom disease had progressed after first‐line EGFR‐TKI treatment. This subanalysis evaluated the safety and efficacy of osimertinib specifically in 63 Japanese patients enrolled in AURA3. The primary end‐point was progression‐free survival (PFS) based on investigator assessment. Improvement in PFS was clinically meaningful in the osimertinib group (n = 41) vs the platinum‐pemetrexed group (n = 22; hazard ratio 0.27; 95% confidence interval, 0.13‐0.56). The median PFS was 12.5 and 4.3 months in the osimertinib and platinum‐pemetrexed groups, respectively. Grade ≥3 adverse events determined to be related to treatment occurred in 5 patients (12.2%) treated with osimertinib and 12 patients (54.5%) treated with platinum‐pemetrexed. The safety and efficacy results in this subanalysis are consistent with the results of the overall AURA3 study, and support the use of osimertinib in Japanese patients with EGFR T790M mutation‐positive NSCLC whose disease has progressed following first‐line EGFR‐TKI treatment. (ClinicalTrials.gov trial registration no. NCT02151981.)

Journal

• Cancer science

  Cancer science 109 (6), 1930-1938, 2018-06

  Wiley

Keywords

• epidermal growth factor receptor
• Japanese
• mutation
• non‐small‐cell lung cancer
• tyrosine kinase

Details

• CRID: 1050845760790484864
• NII Article ID: 120006496875
• ISSN: 13479032
• HANDLE: 2433/233105
• Web Site: https://search.jamas.or.jp/link/ui/2019267435
• Text Lang: en
• Article Type: journal article
• Data Source:
  • IRDB
  • CiNii Articles