OBJECTIVES The J-ALEX study compared the efficacy and safety of alectinib with crizotinib in Japanese patients with advanced ALK-positive non-small-cell lung cancer (NSCLC). Superiority in independent review facility (IRF)-assessed progression-free survival (PFS) was demonstrated for alectinib at the second pre-planned interim PFS analysis (data cutoff: December 3, 2015; hazard ratio [HR] 0.34, 99.7 % confidence interval [CI]: 0.17-0.71, P < 0.0001). We report final PFS data and the second pre-planned interim analysis of overall survival (OS) and safety (data cutoff: June 30, 2018). METHODS Patients aged ≥20 years who were ALK inhibitor-naïve and chemotherapy-naïve, or had received one prior chemotherapy regimen, were randomized to receive alectinib 300 mg (n = 103) or crizotinib 250 mg (n = 104) twice daily. The primary end point was IRF-assessed PFS. Secondary end points included OS and safety. All patients entered survival follow-up in July 2018. RESULTS Median follow-up was 42.4 months for alectinib and 42.2 months for crizotinib. Sustained improvement in IRF-assessed PFS with alectinib was shown (HR 0.37, 95 % CI: 0.26-0.52; median PFS 34.1 months vs 10.2 months crizotinib). At the second interim OS analysis, superiority of alectinib to crizotinib could not be concluded (stratified HR 0.80, 99.8799 % CI: 0.35-1.82, stratified log-rank P = 0.3860; median OS not reached alectinib vs 43.7 months crizotinib). Fewer alectinib-treated patients experienced grade ≥3 adverse events (36.9 % vs 60.6 % crizotinib). CONCLUSIONS At the final PFS analysis, alectinib continued to demonstrate superiority in IRF-assessed PFS versus crizotinib in ALK-inhibitor-naïve ALK-positive NSCLC, with a favorable safety profile. OS follow-up continues.

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最终的无进展生存期来自Alectinib与crizotinib在ALK阳性非小细胞肺癌中的J-ALEX研究。

目的J-ALEX研究比较了艾来替尼和克唑替尼在日本晚期ALK阳性非小细胞肺癌（NSCLC）患者中的疗效和安全性。在第二个预先计划的中期PFS分析中显示了艾来替尼在独立审查设施（IRF）评估的无进展生存期（PFS）方面的优势（数据截止日期：2015年12月3日；危险比[HR] 0.34，99.7％置信区间[CI]：0.17-0.71，P ＜0.0001）。我们报告了最终的PFS数据以及总生存期（OS）和安全性的第二个预先计划的中期分析（数据截止日期：2018年6月30日）。方法年龄≥20岁，未接受过ALK抑制剂和未接受过化疗或已接受过一种化疗方案的患者，随机接受每天两次两次接受alectinib 300 mg（n = 103）或crizotinib 250 mg（n = 104）的治疗。主要终点是IRF评估的PFS。次要终点包括操作系统和安全性。所有患者均于2018年7月接受了生存期随访。结果艾乐替尼的中位随访时间为42.4个月，克唑替尼的中位随访时间为42.2个月。使用依乐替尼的IRF评估的PFS持续改善（HR 0.37，95％CI：0.26-0.52； PFS中位数为34.1个月，而crizotinib则为10.2个月）。在第二次中期OS分析中，尚不能得出alectinib优于crizotinib的优势（分层HR 0.80，99.8799％CI：0.35-1.82，分层对数秩P = 0.3860；中位OS尚未达到alectinib与crizotinib的43.7个月）。接受艾乐替尼治疗的患者发生≥3级不良事件的发生率更低（36.9％vs克唑替尼60.6％）。结论在最终的PFS分析中，在未接受ALK抑制剂的ALK阳性NSCLC患者中，alectinib在IRF评估的PFS中继续显示优于crizotinib的优越性，并具有良好的安全性。操作系统跟进继续。