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avelumab，一种抗 PD-L1 抗体，用于局部晚期或转移性乳腺癌患者：JAVELIN 固体肿瘤研究 1b 期。

Avelumab, an anti-PD-L1 antibody, in patients with locally advanced or metastatic breast cancer: a phase 1b JAVELIN Solid Tumor study.

机构信息

Sint Augustinus-University of Antwerp, Antwerp, Belgium.

Semmelweis University, Budapest, Hungary.

出版信息

Breast Cancer Res Treat. 2018 Feb;167(3):671-686. doi: 10.1007/s10549-017-4537-5. Epub 2017 Oct 23.

DOI:10.1007/s10549-017-4537-5
PMID:29063313
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5807460/
Abstract

PURPOSE: Agents targeting programmed death receptor 1 (PD-1) or its ligand (PD-L1) have shown antitumor activity in the treatment of metastatic breast cancer (MBC). The aim of this study was to assess the activity of avelumab, a PD-L1 inhibitor, in patients with MBC. METHODS: In a phase 1 trial (JAVELIN Solid Tumor; NCT01772004), patients with MBC refractory to or progressing after standard-of-care therapy received avelumab intravenously 10 mg/kg every 2 weeks. Tumors were assessed every 6 weeks by RECIST v1.1. Adverse events (AEs) were graded by NCI-CTCAE v4.0. Membrane PD-L1 expression was assessed by immunohistochemistry (Dako PD-L1 IHC 73-10 pharmDx). RESULTS: A total of 168 patients with MBC, including 58 patients with triple-negative breast cancer (TNBC), were treated with avelumab for 2-50 weeks and followed for 6-15 months. Patients were heavily pretreated with a median of three prior therapies for metastatic or locally advanced disease. Grade ≥ 3 treatment-related AEs occurred in 13.7% of patients, including two treatment-related deaths. The confirmed objective response rate (ORR) was 3.0% overall (one complete response and four partial responses) and 5.2% in patients with TNBC. A trend toward a higher ORR was seen in patients with PD-L1+ versus PD-L1- tumor-associated immune cells in the overall population (16.7% vs. 1.6%) and in the TNBC subgroup (22.2% vs. 2.6%). CONCLUSION: Avelumab showed an acceptable safety profile and clinical activity in a subset of patients with MBC. PD-L1 expression in tumor-associated immune cells may be associated with a higher probability of clinical response to avelumab in MBC.

摘要

目的：靶向程序性死亡受体 1（PD-1）或其配体（PD-L1）的药物在转移性乳腺癌（MBC）的治疗中显示出抗肿瘤活性。本研究旨在评估 PD-L1 抑制剂avelumab 在 MBC 患者中的活性。

方法：在一项 I 期试验（JAVELIN Solid Tumor；NCT01772004）中，对标准治疗后进展或耐药的 MBC 患者静脉注射avelumab，剂量为 10mg/kg，每 2 周 1 次。每 6 周通过 RECIST v1.1 评估肿瘤。不良事件（AE）根据 NCI-CTCAE v4.0 分级。通过免疫组化（Dako PD-L1 IHC 73-10 pharmDx）评估膜 PD-L1 表达。

结果：共 168 例 MBC 患者接受 avelumab 治疗，其中 58 例为三阴性乳腺癌（TNBC）患者，治疗时间为 2-50 周，随访时间为 6-15 个月。患者在转移性或局部晚期疾病中接受了中位数为三种的前期治疗。13.7%的患者发生了≥3 级治疗相关的 AE，包括 2 例治疗相关死亡。总体客观缓解率（ORR）为 3.0%（1 例完全缓解和 4 例部分缓解），TNBC 患者为 5.2%。在总体人群中，PD-L1+肿瘤相关免疫细胞患者的 ORR 较高（16.7%比 1.6%），在 TNBC 亚组中，ORR 较高（22.2%比 2.6%）。

结论：avelumab 在 MBC 的部分患者中显示出可接受的安全性和临床活性。肿瘤相关免疫细胞中的 PD-L1 表达可能与 MBC 患者对 avelumab 更高的临床反应概率相关。

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本文引用的文献

[1]
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Lancet Oncol. 2017-5

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