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在检查点抑制剂治疗的黑色素瘤中,RNA疫苗驱动免疫力

Ugur Sahin^1,2,3,4, Petra Oehm⁵, Evelyna Derhovanessian⁵

¹BioNTech, Mainz, Germany. ugur.sahin@biontech.de.

|July 31, 2020

概括

在先前用检查点抑制剂治疗的晚期黑色素瘤患者中,新型癌症疫苗FixVac显示出持久的反应. 这种RNA-LPX疫苗刺激强烈,持久的免疫反应, 为难以治疗的癌症提供新的希望.

科学领域:

癌症学
免疫学
疫苗开发

背景情况:

癌症疫苗旨在刺激向性免疫反应,但在晚期治疗不耐药的瘤中表现出有限的成功.
晚期黑色素瘤患者,特别是那些在检查点抑制剂上进展的患者,代表着重要的未满足的医疗需求.

研究的目的:

评估黑色素瘤FixVac (BNT111) 疫苗的安全性和有效性,该疫苗是RNA- 脂质体纳米粒子 (RNA- LPX) 疫苗,用于晚期黑色素瘤患者.
评估黑色素瘤FixVac诱导的免疫反应,单独或与PD1阻塞结合,在检查点抑制剂 (CPI) 经验的患者.

主要方法:

一个正在进行的,首次在人体上进行的,剂量升级的第一阶段试验 (Lipo- MERIT) 正在评估黑色素瘤FixVac在晚期黑色素瘤患者中.
这项研究涉及静脉注射RNA-LPX疫苗,针对四种流行,非突变的瘤相关抗原.
一项探索性临时分析包括之前接受过检查点抑制剂治疗的患者.

主要成果:

黑色素瘤FixVac,单独或与PD1阻塞结合,在CPI经验丰富的黑色素瘤患者中显示出持久的客观反应.
临床反应与强大的CD4+和CD8+T细胞免疫对疫苗抗原的诱导有关.
对抗原特异性细胞毒性T细胞的反应达到与采用T细胞治疗相当的程度,并且持久.

结论:

在CPI患有黑色素瘤的患者中,RNA- 脂质体纳米颗粒 (RNA- LPX) 疫苗是有效的免疫疗法.
这些发现表明非突变共享瘤抗原是开发有效癌症疫苗的可行目标.
黑色素瘤FixVac有望改善晚期黑色素瘤的治疗结果,特别是在对当前疗法的耐药性患者中.

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