Phase II study of ERC1671 plus bevacizumab versus bevacizumab plus placebo in recurrent glioblastoma: interim results and correlations with CD4⁺ T-lymphocyte counts.

Q1 Medicine

CNS Oncology Pub Date : 2018-07-01 Epub Date: 2018-08-29 DOI:10.2217/cns-2018-0009

Daniela A Bota, Jinah Chung, Manisha Dandekar, Jose A Carrillo, Xiao-Tang Kong, Beverly D Fu, Frank Pk Hsu, Axel H Schönthal, Florence M Hofman, Thomas C Chen, Raphael Zidovetzki, Chrystel Pretto, Ankie Strik, Virgil Ejc Schijns, Apostolos Stathopoulos

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引用次数: 42

Abstract

Aim: ERC1671 is an allogeneic/autologous therapeutic glioblastoma (GBM) vaccine - composed of whole, inactivated tumor cells mixed with tumor cell lysates derived from the patient and three GBM donors.

Methods: In this double-blinded, randomized, Phase II study bevacizumab-naive patients with recurrent GBM were randomized to receive either ERC1671 in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF) (Leukine^® or sargramostim) and cyclophosphamide plus bevacizumab, or placebo plus bevacizumab. Interim results: Median overall survival (OS) of patients treated with ERC1671 plus bevacizumab was 12 months. In the placebo plus bevacizumab group, median OS was 7.5 months. The maximal CD4⁺ T-lymphocyte count correlated with OS in the ERC1671 but not in the placebo group.

Conclusion: The addition of ERC1671/GM-CSF/cyclophosphamide to bevacizumab resulted in a clinically meaningful survival benefit with minimal additional toxicity.

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ERC1671联合贝伐单抗与贝伐单抗联合安慰剂治疗复发性胶质母细胞瘤的II期研究:中期结果和与CD4+ t淋巴细胞计数的相关性

目的:ERC1671是一种同种异体/自体治疗性胶质母细胞瘤(GBM)疫苗，由全灭活肿瘤细胞与来自患者和三位GBM供体的肿瘤细胞裂解液混合而成。方法:在这项双盲、随机、II期研究中，贝伐单抗治疗的复发性GBM患者随机接受ERC1671联合粒细胞-巨噬细胞集落刺激因子(GM-CSF) (Leukine®或sargramostim)和环磷酰胺加贝伐单抗治疗，或安慰剂加贝伐单抗治疗。中期结果:ERC1671联合贝伐单抗治疗的患者中位总生存期(OS)为12个月。在安慰剂加贝伐单抗组中，中位生存期为7.5个月。ERC1671组的最大CD4+ t淋巴细胞计数与OS相关，而安慰剂组没有。结论:在贝伐单抗中加入ERC1671/GM-CSF/环磷酰胺可获得具有临床意义的生存获益，且毒性最小。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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