Safety, immunogenicity and preliminary efficacy of multiple-site vaccination with an Epidermal Growth Factor (EGF) based cancer vaccine in advanced non small cell lung cancer (NSCLC) patients.

Pedro C Rodriguez, Elia Neninger, Beatriz García, Xitlally Popa, Carmen Viada, Patricia Luaces, Gisela González, Agustin Lage, Enrique Montero, Tania Crombet
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引用次数: 24

Abstract

The prognosis of patients with advanced non small cell lung (NSCLC) cancer remains dismal. Epidermal Growth Factor Receptor is over-expressed in many epithelial derived tumors and its role in the development and progression of NSCLC is widely documented. CimaVax-EGF is a therapeutic cancer vaccine composed by human recombinant Epidermal Growth Factor (EGF) conjugated to a carrier protein, P64K from Neisseria Meningitides. The vaccine is intended to induce antibodies against self EGF that would block EGF-EGFR interaction. CimaVax-EGF has been evaluated so far in more than 1000 advanced NSCLC patients, as second line therapy. Two separate studies were compared to assess the impact of high dose vaccination at multiple anatomic sites in terms of immunogenicity, safety and preliminary efficacy in stage IIIb/IV NSCLC patients. In both clinical trials, patients started vaccination 1 month after finishing first line chemotherapy. Vaccination at 4 sites with 2.4 mg of EGF (high dose) was very safe. The most frequent adverse events were grade 1 or 2 injection site reactions, fever, headache and vomiting. Patients had a trend toward higher antibody response. The percent of very good responders significantly augmented and there was a faster decrease of circulating EGF. All vaccinated patients and those classified as good responders immunized with high dose at 4 sites, had a large tendency to improved survival.

Abstract Image

基于表皮生长因子(EGF)的癌症疫苗在晚期非小细胞肺癌(NSCLC)患者多部位接种的安全性、免疫原性和初步疗效
晚期非小细胞肺癌(NSCLC)患者的预后仍然令人沮丧。表皮生长因子受体在许多上皮源性肿瘤中过表达,其在非小细胞肺癌发生发展中的作用已被广泛报道。CimaVax-EGF是一种治疗性癌症疫苗,由人重组表皮生长因子(EGF)结合来自脑膜炎奈瑟菌的载体蛋白P64K组成。该疫苗旨在诱导针对自身EGF的抗体,从而阻断EGF- egfr相互作用。迄今为止,CimaVax-EGF已在超过1000名晚期NSCLC患者中作为二线治疗进行了评估。比较了两项独立的研究,以评估在多个解剖部位接种高剂量疫苗对IIIb/IV期NSCLC患者的免疫原性、安全性和初步疗效的影响。在两项临床试验中,患者在完成一线化疗后1个月开始接种疫苗。在4个地点接种2.4 mg EGF(高剂量)是非常安全的。最常见的不良事件为1级或2级注射部位反应、发热、头痛和呕吐。患者有抗体反应增高的趋势。非常好的应答者的百分比显著增加,循环EGF下降更快。所有接种疫苗的患者和在4个地点接种高剂量疫苗的良好应答者有很大的生存率提高趋势。
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