本次适应证获批是基于CROWN III期研究的结果。在2020年欧洲肿瘤内科学会(ESMO)年会上,该研究公布了结果。这项III期研究纳入了296例初治的ALK重排阳性晚期NSCLC患者,一线使用劳拉替尼或克唑替尼进行治疗。主要研究终点为盲化独立评审委员会(BIRC)评估的中位无进展生存期(PFS)。CROWN研究设计图结果显示,根据BIRC评估,相比克唑替尼,劳拉替尼显著性延长了中位PFS(未达到 vs 9.3个月),降低了72%的疾病进展或死亡风险(HR 0.28,P<0.001)。根据研究者评估的结果,劳拉替尼同样显著延长了中位PFS(未达到 vs 9.1个月,HR 0.21)。PFS结果此外,劳拉替尼的全身客观缓解率(ORR)为76%,而克唑替尼组为58%。值得注意的是,劳拉替尼治疗的颅内ORR达到82%,显著优于克唑替尼组的23%。其中,有71%(12例)具有可测量脑转移病灶的患者使用劳拉替尼后达到颅内病灶完全缓解(CR),充分印证了劳拉替尼的入脑能力。颅内疗效在安全性方面,劳拉替尼和克唑替尼组出现3/4级不良反应的发生率分别为72% vs 56%。
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