III期临床试验证实Keytruda联用阿西替尼显著降低晚期肾癌的死亡率

2019-02-19 不详 MedSci原创

III期KEYNOTE-426试验证实,与晚期肾细胞癌(RCC)的一线治疗药物舒尼替尼相比,MSD的抗PD-1疗法Keytruda(pembrolizumab)和辉瑞的酪氨酸激酶抑制剂Inlyta(阿西替尼)的联用可以将患者的死亡风险降低近一半。

III期KEYNOTE-426试验证实,与晚期肾细胞癌(RCC)的一线治疗药物舒尼替尼相比,MSD的抗PD-1疗法Keytruda(pembrolizumab)和辉瑞的酪氨酸激酶抑制剂Inlyta(阿西替尼)的联用可以将患者的死亡风险降低近一半。

该研究的双重终点是总体存活率(OS)和无进展存活期(PFS),次要终点包括客观反应率(ORR)、安全性、反应持续时间、12、18和24个月的PFS以及12、18和24个月的OS。

首次中期分析的结果显示,该药物组合使死亡风险降低了47%,而且将接受该组合药物治疗的患者ORR达到59.3%。

美国食品和药物管理局(FDA)目前已经对Keytruda的补充生物制剂许可申请(sBLA)进行了优先审查,从而与Inlyta联用作为晚期RCC患者的一线治疗。

KEYNOTE-426的首席研究员Thomas Powles博士说:"晚期RCC患者的五年生存率不到10%。考虑到这种疾病的侵略性和长期预后不良,Keytruda联合阿西替尼将为晚期肾细胞癌患者提供一种新的治疗方案。"

肾细胞癌是迄今为止最常见的肾癌类型,大约十分之九的肾癌是RCC,这种疾病在男性中的发病率大约是女性中的两倍。

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    2019-12-31 juliusluan78
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  5. 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  6. 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  7. 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    2019-02-19 医者仁心5538

    学习了

    0

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