用于治疗非小细胞肺癌的拉考珠单抗-明矾疫苗。

Racotumomab-alum vaccine for the treatment of non-small-cell lung cancer.

作者信息

Hernández Ana María, Vázquez Ana María

机构信息

Center for Molecular Immunology - Tumor Biology, 15th Ave and 217 Street, Atabey, Playa, Habana, Cuba.

出版信息

Expert Rev Vaccines. 2015 Jan;14(1):9-20. doi: 10.1586/14760584.2015.984691. Epub 2014 Nov 25.

Abstract

Racotumomab-alum vaccine is an anti-idiotypic vaccine able to mimic the tumor-associated antigen NeuGcGM3. Different Phase I clinical trials and compassionate use studies demonstrated its low toxicity and capacity to induce a strong anti-NeuGcGM3 response, able to bind and directly kill tumor cells expressing the antigen. A Phase II/III randomized double-blind clinical trial in advanced non-small cell lung cancer patients showed a significant improvement in overall survival and progression-free survival for racotumomab-alum versus placebo. Patients who developed anti-NeuGcGM3 antibodies capable of binding and killing NeuGcGM3 expressing tumor cells showed significantly longer median survival times. The impact of using racotumomab-alum as switch maintenance followed by second-line therapy is currently being explored in a new randomized, multinational Phase III study.

摘要

拉科妥单抗-明矾疫苗是一种能够模拟肿瘤相关抗原NeuGcGM3的抗独特型疫苗。不同的I期临床试验和同情用药研究证明了其低毒性以及诱导强烈抗NeuGcGM3反应的能力,该反应能够结合并直接杀死表达该抗原的肿瘤细胞。一项针对晚期非小细胞肺癌患者的II/III期随机双盲临床试验表明,与安慰剂相比,拉科妥单抗-明矾疫苗在总生存期和无进展生存期方面有显著改善。产生能够结合并杀死表达NeuGcGM3的肿瘤细胞的抗NeuGcGM3抗体的患者,其平均生存期显著更长。目前正在一项新的随机、多国III期研究中探索使用拉科妥单抗-明矾疫苗作为转换维持治疗随后进行二线治疗的影响。

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