Introduction: The efficacy and safety of atezolizumab versus the efficacy and safety of docetaxel as second‐ or third‐line treatment in patients with advanced NSCLC in the primary (n = 850) and secondary (n = 1225) efficacy populations of the randomized phase III OAK study (respectively referred to as the intention‐to‐treat [ITT] 850 [ITT850] and ITT1225) at an updated data cutoff were assessed. Methods: Patients received atezolizumab, 1200 mg, or docetaxel, 75 mg/m2, intravenously every 3 weeks until loss of clinical benefit or disease progression, respectively. The primary end point was overall survival (OS) in the ITT population and programmed death‐ligand 1–expressing subgroup. A sensitivity analysis was conducted to evaluate the impact of subsequent immunotherapy use in the docetaxel arm on the observed survival benefit with atezolizumab. Results: Atezolizumab demonstrated an OS benefit versus docetaxel in the updated ITT850 (hazard ratio [HR] = 0.75, 95% confidence interval: 0.64–0.89, p = 0.0006) and the ITT1225 (HR = 0.80, 95% confidence interval: 0.70–0.92, p = 0.0012) after minimum follow‐up times of 26 and 21 months, respectively. Improved survival with atezolizumab was observed across programmed death‐ligand 1 and histological subgroups. In the immunotherapy sensitivity analysis, the relative OS benefit with atezolizumab was slightly greater in the ITT850 (HR = 0.69) and ITT1225 (HR = 0.74) than the conventional OS estimate. Fewer patients receiving atezolizumab experienced grade 3 or 4 treatment‐related adverse events (14.9%) than did patients receiving docetaxel (42.4%); no grade 5 adverse events related to atezolizumab were observed. Conclusions: The results of the updated ITT850 and initial ITT1225 analyses were consistent with those of the primary efficacy analysis demonstrating survival benefit with atezolizumab versus with docetaxel. Atezolizumab continued to demonstrate a favorable safety profile after longer treatment exposure and follow‐up.

中文翻译：

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更新的疗效分析，包括 OAK 的次要人群结果：atezolizumab 与多西他赛在既往接受过治疗的晚期非小细胞肺癌患者中的随机 III 期研究

简介：在随机 III 期的主要 (n = 850) 和次要 (n = 1225) 疗效人群中，阿特珠单抗作为二线或三线治疗晚期 NSCLC 患者的疗效和安全性对比多西他赛的疗效和安全性评估了更新数据截止点的 OAK 研究（分别称为意向治疗 [ITT] 850 [ITT850] 和 ITT1225）。方法：患者每 3 周接受一次静脉注射阿特珠单抗 1200 mg 或多西他赛 75 mg/m2，直至分别失去临床获益或疾病进展。主要终点是 ITT 人群和程序性死亡配体 1 表达亚组的总生存期 (OS)。进行了敏感性分析以评估在多西他赛组中使用后续免疫治疗对观察到的阿特珠单抗生存获益的影响。结果：在更新的 ITT850（风险比 [HR] = 0.75，95% 置信区间：0.64–0.89，p = 0.0006）和 ITT1225（HR = 0.80，95% 置信区间：0.70– 0.92, p = 0.0012) 在最短随访时间分别为 26 和 21 个月后。在程序性死亡配体 1 和组织学亚组中观察到使用 atezolizumab 提高了生存率。在免疫治疗敏感性分析中，在 ITT850 (HR = 0.69) 和 ITT1225 (HR = 0.74) 中，atezolizumab 的相对 OS 获益略高于常规 OS 估计值。与接受多西他赛的患者 (42.4%) 相比，接受阿特珠单抗治疗的患者发生 3 级或 4 级治疗相关不良事件的患者 (14.9%) 更少；未观察到与阿特珠单抗相关的 5 级不良事件。结论：更新的 ITT850 和初始 ITT1225 分析的结果与主要疗效分析的结果一致，证明了阿特珠单抗与多西他赛相比的生存获益。Atezolizumab 在长期治疗暴露和随访后继续表现出良好的安全性。