默沙东的Keytruda治疗小细胞肺癌的III期临床,未能明显改善患者的总体生存率

2020-01-08 不详 MedSci原创

来自III期KEYNOTE-604试验的最新数据显示,默沙东的PD-1单抗Keytruda(派姆单抗)的结果好坏参半。与单独化疗相比,Keytruda联合化疗用作一线治疗可显着改善小细胞肺癌(SCLC)患者的无进展生存期(PFS)。

来自III期KEYNOTE-604试验的最新数据显示,默沙东的PD-1单抗Keytruda(派姆单抗)的结果好坏参半。与单独化疗相比,Keytruda联合化疗用作一线治疗可显着改善小细胞肺癌(SCLC)患者的无进展生存期(PFS)。

但是Keytruda在总体生存率(OS)的 "结果未达到预先设定的研究计划的统计意义",未达到主要终点。

该试验招募了453例新诊断的广泛期SCLC患者,这些患者先前未曾接受过全身治疗,被随机分配接受Keytruda或安慰剂治疗,与依托泊苷和其他铂类化疗相联合。

去年,美国食品药品监督管理局(FDA)批准将罗氏的抗PD-L1单抗Tecentriq(atezolizumab)与化学药物联合用于广泛期的SCLC患者,使其成为该适应症中首个获准使用的癌症免疫疗法。

早在去年11月,欧洲委员会就已批准该疗法用作转移性或不可切除的复发性头颈部鳞状细胞癌(HNSCC)患者一线治疗的单一疗法或作为组合疗法的一部分。

肺癌是全球癌症死亡的主要原因,每年死于肺癌的人数超过了结肠癌乳腺癌的总和。SCLC约占所有肺癌的10%至15%。

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    2020-01-10 yese
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当地时间9月4日,默沙东宣布欧盟委员会已批准抗PD-1疗法Keytruda联合酪氨酸激酶抑制剂Inlyta一线治疗晚期肾细胞癌(RCC),该批准适用于国际转移性肾癌数据库联盟(IMDC)全部风险类别。此次批准也使Keytruda成为欧洲批准的首个用于组合方案治疗IMDC全部风险类别患者的抗PD-1疗法。此次批准基于关键III期研究KEYNOTE-426的结果。

前高管携大量研发机密跳槽辉瑞,后知后觉的默沙东能否跑赢这场疫苗大战?

默沙东和辉瑞在下一代肺炎球菌疫苗的研发已经是一场公开的竞赛,但是并非所有的竞赛都能做到公平公正。近日,FiercePharma公开一份内幕,默沙东声明,其一名前高层员工带着大量商业秘密跳槽到了辉瑞,这给辉瑞增加不少不公平竞争的优势。