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Osimertinib in Japanese patients with EGFR T790M mutation‐positive advanced non‐small‐cell lung cancer: AURA 3 trial

2018; Wiley; Volume: 109; Issue: 6 Linguagem: Inglês

10.1111/cas.13623

1349-7006

Hiroaki Akamatsu, Nobuyuki Katakami, Isamu Okamoto, Terufumi Kato, Young Hak Kim, Fumio Imamura, Masaharu Shinkai, Rachel Hodge, Hirohiko Uchida, Toyoaki Hida,

Cancer therapeutics and mechanisms

Epidermal growth factor receptor ( EGFR ) tyrosine kinase inhibitors ( TKI s) 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. AURA 3 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/m 2 ) 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 AURA 3. 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 AURA 3 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. NCT 02151981.)