强生双抗组合疗法获欧盟批准:一线治疗肺癌,风险降30%

智通财经
22 Jan

1月22日,强生公司今日宣布,欧盟委员会已批准Lazcluze(lazertinib)与Rybrevant(amivantamab)联用,一线治疗携带表皮生长因子受体(EGFR)第19号外显子缺失(ex19del)或第21号外显子L858R突变的晚期非小细胞肺癌(NSCLC)成年患者。欧盟委员会的批准基于3期临床试验MARIPOSA的结果。该研究评估了Lazcluze联合Rybrevant,与活性对照osimertinib相比,一线治疗携带上述EGFR变异的NSCLC患者的疗效。分析显示,Rybrevant与Lazcluze联用,与活性对照药物相比,可将疾病进展或死亡风险降低30%。

联合疗法与活性对照药物组患者的中位无进展生存期(PFS)分别为23.7个月与16.6个月。此外,联合疗法组的中位缓解持续时间(DOR)比活性对照药物长9个月(25.8个月比16.7个月)。2025年1月7日,强生公司宣布了积极的总生存期(OS)顶线结果,显示Lazcluze联合Rybrevant达到了预先设定的次要终点,与现有标准治疗相比,为OS提供了统计显著并具有临床意义的改善。这些具有里程碑意义的OS数据将于即将召开的医学会议上发布。

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