Introduction: Here we report efficacy and safety data of an Asian subset of the phase III FLAURA trial (NCT02296125), which compares osimertinib with standard of care (SoC) EGFR tyrosine kinase inhibitors (TKIs) in patients with previously untreated advanced NSCLC with tumors harboring exon 19 deletion (Ex19del)/L858R EGFR TKI–sensitizing mutations. Methods: Eligible Asian patients (enrolled at Asian sites) who were at least 18 years of age (≥20 years in Japan) and had untreated EGFR‐mutated advanced NSCLC were randomized 1:1 to receive osimertinib (80 mg, orally once daily) or an SoC EGFR TKI (gefitinib, 250 mg, or erlotinib, 150 mg, orally once daily). The primary end point was investigator‐assessed progression‐free survival (PFS). The key secondary end points were overall survival, objective response rate, central nervous system efficacy, and safety. Results: The median PFS was 16.5 versus 11.0 months for the osimertinib and SoC EGFR TKI groups, respectively (hazard ratio = 0.54, 95% confidence interval: 0.41–0.72, p < 0.0001). The overall survival data were immature (24% maturity). The objective response rates were 80% for osimertinib and 75% for an SoC EGFR TKI. The median central nervous system PFS was not calculable for the osimertinib group and was 13.8 months for the SoC EGFR TKI group (hazard ratio = 0.55, 95% confidence interval: 0.25–1.17, p = 0.118). Fewer adverse events of grade 3 or higher (40% versus 48%) and fewer adverse events leading to treatment discontinuation (15% versus 21%) were reported with osimertinib versus with an SoC EGFR TKI, respectively. Conclusion: In this Asian population, first‐line osimertinib demonstrated a clinically meaningful improvement in PFS over an SoC EGFR TKI, with a safety profile consistent with that for the overall FLAURA study population.

中文翻译：

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奥希替尼与标准护理 EGFR-TKI 作为 EGFRm 晚期 NSCLC 患者的一线治疗：FLAURA 亚洲亚组

介绍：我们在此报告了 III 期 FLAURA 试验 (NCT02296125) 亚洲子集的疗效和安全性数据，该试验将奥希替尼与标准护理 (SoC) EGFR 酪氨酸激酶抑制剂 (TKI) 用于既往未经治疗且携带肿瘤的晚期 NSCLC 患者的疗效和安全性数据。外显子 19 缺失 (Ex19del)/L858R EGFR TKI 致敏突变。方法：符合条件的年龄在 18 岁以上（日本≥20 岁）且未经治疗的 EGFR 突变晚期 NSCLC 的合格亚洲患者（在亚洲站点招募）以 1:1 的比例随机接受奥希替尼（80 mg，每天口服一次）或 SoC EGFR TKI（吉非替尼，250 毫克，或厄洛替尼，150 毫克，每天口服一次）。主要终点是研究者评估的无进展生存期（PFS）。关键次要终点是总生存期、客观缓解率、中枢神经系统疗效、和安全。结果：奥希替尼和 SoC EGFR TKI 组的中位 PFS 分别为 16.5 个月和 11.0 个月（风险比 = 0.54，95% 置信区间：0.41–0.72，p < 0.0001）。总体生存数据尚不成熟（成熟度为 24%）。奥希替尼的客观缓解率为 80%，SoC EGFR TKI 的客观缓解率为 75%。奥希替尼组的中位中枢神经系统 PFS 无法计算，SoC EGFR TKI 组为 13.8 个月（风险比 = 0.55，95% 置信区间：0.25–1.17，p = 0.118）。与 SoC EGFR TKI 相比，奥希替尼报告的 3 级或更高级别的不良事件更少（40% 对 48%）和导致治疗中断的不良事件更少（15% 对 21%）。结论：在这个亚洲人群中，