avelumab 对比多西他赛用于铂类化疗后晚期非小细胞肺癌患者：JAVELIN Lung 200 期 3 研究 2 年随访结果
Avelumab Versus Docetaxel in Patients With Platinum-Treated Advanced NSCLC: 2-Year Follow-Up From the JAVELIN Lung 200 Phase 3 Trial.
机构信息
Division of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
Division of Medical Oncology, Department of Internal Medicine, Cerrahpaşa Medical Faculty, Istanbul University-Cerrahpaşa, Istanbul, Turkey.
出版信息
J Thorac Oncol. 2021 Aug;16(8):1369-1378. doi: 10.1016/j.jtho.2021.03.009. Epub 2021 Apr 9.
INTRODUCTION
In the JAVELIN Lung 200 trial, avelumab (anti-programmed death-ligand 1 [PD-L1] antibody) did not significantly prolong overall survival (OS) versus docetaxel in patients with platinum-treated PD-L1+ NSCLC. We report greater than 2-year follow-up data.
METHODS
Patients with stage IIIB or IV or recurrent NSCLC with disease progression after platinum-doublet chemotherapy were randomized 1:1 to avelumab 10 mg/kg every 2 weeks or docetaxel 75 mg/m every 3 weeks. The primary end point was OS in patients with PD-L1+ tumors (greater than or equal to 1% tumor cell expression; IHC 73-10 pharmDx assay).
RESULTS
Of 792 patients, 529 had PD-L1+ tumors (264 versus 265 in the avelumab versus docetaxel arms, respectively). As of March 4, 2019, median duration of follow-up for OS in the PD-L1+ population was 35.4 months in the avelumab arm and 34.7 months in the docetaxel arm; study treatment was ongoing in 25 (9.5%) versus 0 patients, respectively. In the PD-L1+ population, 2-year OS rates (95% confidence interval [CI]) with avelumab versus docetaxel were 29.9% (24.5%-35.5%) versus 20.5% (15.6%-25.8%); in greater than or equal to 50% PD-L1+ subgroups, 2-year OS rates were 36.4% (29.1%-43.7%) versus 17.7% (11.8%-24.7%) and in the greater than or equal to 80% subgroup were 40.2% (31.3%-49.0%) versus 20.3% (12.9%-28.8%), respectively. Median duration of response (investigator assessed) was 19.1 months (95% CI: 10.8-34.8) versus 5.7 months (95% CI: 4.1-8.3). Safety profiles for both arms were consistent with the primary analysis.
CONCLUSIONS
Although the JAVELIN Lung 200 primary analysis (reported previously) revealed that avelumab did not significantly prolong OS versus docetaxel in patients with platinum-treated PD-L1+ NSCLC, posthoc analyses at 2 years of follow-up revealed that 2-year OS rates were doubled with avelumab in subgroups with higher PD-L1 expression (greater than or equal to 50% and greater than or equal to 80%).
简介
在 JAVELIN Lung 200 试验中，avelumab（抗程序性死亡配体 1 [PD-L1] 抗体）与多西他赛相比并未显著延长铂类治疗后 PD-L1+ NSCLC 患者的总生存期（OS）。我们报告了超过 2 年的随访数据。
方法
铂类化疗后疾病进展的 IIIB 或 IV 期或复发性 NSCLC 患者按 1:1 随机分配至avelumab 10mg/kg，每 2 周一次或多西他赛 75mg/m，每 3 周一次。主要终点是 PD-L1+肿瘤患者的 OS（肿瘤细胞表达大于或等于 1%；IHC 73-10 pharmDx 检测）。
结果
在 792 名患者中，529 名患者有 PD-L1+肿瘤（avelumab 组和多西他赛组分别为 264 名和 265 名）。截至 2019 年 3 月 4 日，PD-L1+人群的 OS 中位随访时间为avelumab 组 35.4 个月，多西他赛组 34.7 个月；分别有 25 名（9.5%）和 0 名患者正在接受研究治疗。在 PD-L1+人群中，avelumab 与多西他赛相比的 2 年 OS 率（95%置信区间[CI]）为 29.9%（24.5%-35.5%）和 20.5%（15.6%-25.8%）；在 PD-L1+大于或等于 50%亚组中，2 年 OS 率分别为 36.4%（29.1%-43.7%）和 17.7%（11.8%-24.7%），在 PD-L1+大于或等于 80%亚组中，2 年 OS 率分别为 40.2%（31.3%-49.0%）和 20.3%（12.9%-28.8%）。（研究者评估的）中位缓解持续时间为 19.1 个月（95%CI：10.8-34.8）和 5.7 个月（95%CI：4.1-8.3）。两个治疗组的安全性特征与主要分析一致。
结论
尽管 JAVELIN Lung 200 主要分析（之前报道过）显示，avelumab 与多西他赛相比并未显著延长铂类治疗后 PD-L1+ NSCLC 患者的 OS，但 2 年随访的事后分析显示，高 PD-L1 表达（大于或等于 50%和大于或等于 80%）亚组中avelumab 的 2 年 OS 率增加了一倍。
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