Division of Medical Oncology, The Ohio State University James Cancer Hospital, Columbus, Ohio, USA
Department of Medical Oncology, CHU Sart Tilman Liege and Liege University, Liege, Belgium.
J Immunother Cancer. 2020 Sep;8(2). doi: 10.1136/jitc-2020-001064.
Avelumab, an antiprogrammed death ligand-1 antibody, is approved as a monotherapy for treatment of metastatic Merkel cell carcinoma and advanced urothelial carcinoma, and in combination with axitinib for advanced renal cell carcinoma. We report the efficacy and safety of first-line avelumab in advanced non-small cell lung cancer (NSCLC).
In a phase I expansion cohort of the JAVELIN Solid Tumor trial, patients with treatment-naive, metastatic, or recurrent NSCLC received 10 mg/kg avelumab intravenously every 2 weeks. Endpoints included best overall response, duration of response (DOR), progression-free survival (PFS), overall survival (OS), and safety.
Overall, 156 patients were enrolled and treated. Median duration of follow-up was 18.6 months (range, 15 to 23 months). The objective response rate was 19.9% (95% CI, 13.9 to 27.0), including complete response in 3 (1.9%) and partial response in 28 (17.9%). Median DOR was 12.0 months (95% CI, 6.9 to not estimable). Median PFS was 4.0 months (95% CI, 2.7 to 5.4) and the 6-month PFS rate was 38.5% (95% CI, 30.7 to 46.3). Median OS was 14.1 months (95% CI, 11.3 to 16.9) and the 12-month OS rate was 56.6% (95% CI, 48.2 to 64.1). Treatment-related adverse events (TRAEs) occurred in 107 patients (68.6%), including grade ≥3 TRAEs in 19 (12.2%). Immune-related adverse events and infusion-related reactions occurred in 31 (19.9%) and 40 patients (25.6%), respectively. No treatment-related deaths occurred.
Avelumab showed antitumor activity with a tolerable safety profile as a first-line treatment in patients with advanced NSCLC. These data support further investigation of avelumab in the phase III JAVELIN Lung 100 study.
ClinicalTrials.gov NCT01772004; registered January 21, 2013.
avelumab 是一种抗程序性死亡配体-1 抗体，已被批准用于治疗转移性默克尔细胞癌和晚期尿路上皮癌的单药治疗，以及与 axitinib 联合用于治疗晚期肾细胞癌。我们报告了一线avelumab 在晚期非小细胞肺癌（NSCLC）中的疗效和安全性。
在 JAVELIN 实体瘤试验的 I 期扩展队列中，未经治疗、转移性或复发性 NSCLC 患者接受avelumab 10 mg/kg 每 2 周静脉输注一次。终点包括最佳总体缓解率、缓解持续时间（DOR）、无进展生存期（PFS）、总生存期（OS）和安全性。
共有 156 名患者入组并接受了治疗。中位随访时间为 18.6 个月（范围为 15 至 23 个月）。客观缓解率为 19.9%（95%CI，13.9 至 27.0），包括完全缓解 3 例（1.9%）和部分缓解 28 例（17.9%）。中位 DOR 为 12.0 个月（95%CI，6.9 至无法估计）。中位 PFS 为 4.0 个月（95%CI，2.7 至 5.4），6 个月 PFS 率为 38.5%（95%CI，30.7 至 46.3）。中位 OS 为 14.1 个月（95%CI，11.3 至 16.9），12 个月 OS 率为 56.6%（95%CI，48.2 至 64.1）。107 名患者（68.6%）发生了与治疗相关的不良事件（TRAEs），包括 19 名（12.2%）患者发生了≥3 级 TRAEs。31 名（19.9%）和 40 名（25.6%）患者分别发生了免疫相关不良事件和输液相关反应。无治疗相关死亡。
avelumab 作为晚期 NSCLC 患者的一线治疗药物，具有可耐受的安全性，显示出抗肿瘤活性。这些数据支持在 JAVELIN Lung 100 三期研究中进一步研究 avelumab。
ClinicalTrials.gov NCT01772004；注册于 2013 年 1 月 21 日。
