Inovio的INO-5401联合PD-1单抗cemiplimab治疗多形胶质母细胞瘤的2期研究,显示出80%的6个月无进展生存率

2019-11-06 不详 MedSci原创

Inovio制药公司宣布2期研究(NCT03491683)的阳性结果,在新诊断的胶质母细胞瘤患者中,将INO -5401(编码T细胞活化的三种肿瘤相关抗原酶(hTERT,WT1,和PSMA)),和INO-9012(编码IL-12),与赛诺菲开发的PD-1单抗Libtayo(cemiplimab)联合的药效结果。

Inovio制药公司宣布2期研究(NCT03491683)的阳性结果,在新诊断的胶质母细胞瘤患者中,将INO -5401(编码T细胞活化的三种肿瘤相关抗原酶(hTERT,WT1,和PSMA)),和INO-9012(编码IL-12),与赛诺菲开发的PD-1单抗Libtayo(cemiplimab)联合的药效结果。

这项来自52名患者的临床试验数据显示,六个月内,MGMT基因启动子甲基化患者中有80%(20个中的16个)和未甲基化患者中75%(32个中的24个)无进展生存期(PFS6)远远超过了历史护理标准数据。

这种与PD-1检查点抑制剂结合的免疫疗法还显示出安全性、耐受性和免疫原性数据,并提出了与Libtayo和Inovio平台技术一致的可接受的安全性。测试的大多数患者对由INO-5401编码的一种或多种肿瘤相关抗原具有T细胞免疫反应应答。在这项研究中证明了对所有三种肿瘤相关抗原的免疫反应。Inovio计划在明年报告12个月和18个月的总体生存数据。

这项研究的首席研究员兼Dana-Farber癌症研究所神经肿瘤临床主任David Reardon博士说:"这项创新性试验提供了令人鼓舞的信息,即INO-5401与INO-9012的组合,促进T细胞的疗法与检查点抑制剂Libtayo的结合可能在难以治疗的疾病中提供临床上有意义的益处。"

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    2019-12-25 snf701207
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    2020-06-05 zlawrance
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