智通财经APP获悉，强生公司(JNJ.US)今日宣布其3期MARIPOSA研究的顶线结果。分析显示，与当前标准治疗相比，其双特异性抗体Rybrevant(amivantamab)联合第三代表皮生长因子受体(EGFR)酪氨酸激酶抑制剂(TKI)口服药物Lazcluze(lazertinib)，作为一线疗法治疗带有EGFR外显子19缺失(ex19del)或外显子21中L858R替代突变的局部晚期或转移性非小细胞肺癌(NSCLC)成年患者时，可在临床与统计学上显著改善患者的总生存期(OS)。
MARIPOSA是一项随机3期研究，共招募1074名患者。评估Rybrevant与Lazcluze联用，与活性对照奥希替尼(osimertinib)相比的疗效和安全性。研究的主要终点为根据RECIST v1.1标准、经独立盲法中央评审(BICR)评估的无进展生存期(PFS)。次要终点包括OS、客观缓解率(ORR)、缓解持续时间(DOR)、第二次无进展生存期(PFS2)以及颅内PFS。之前试验结果显示，与活性对照药物相比，Rybrevant与Lazcluze联合疗法可降低患者疾病进展或死亡风险达30%。美国FDA在去年8月根据该试验的PFS结果，批准此联合疗法用于治疗相应的患者群体。
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