Evidence from 1 phase III, randomized, open-label, sponsor-blind, multicenter, global study (HIMALAYA; N = 1,324, including 393 patients in the tremelimumab in combination with durvalumab group, and 389 patients in the sorafenib group) demonstrated that treatment with tremelimumab in combination with durvalumab resulted in added clinical benefit in adult patients with unresectable肝细胞癌。喜马拉雅山的研究表明,与杜瓦卢马布(Durvalumab)结合使用tremelimumab的治疗与统计学意义和临床上有意义的总生存率(OS)相关,其中位OS的中位数为16.4个月(95%CI,14.2至19.6)(tremelimumab与Durvalumab组结合16.8个月)(95%CI)(95%CI),与165%CI相比,tremelimumab与165%CI的联合(95%)相关。 (危险比[HR] = 0.78; 96.02%CI,0.65至0.93; P = 0.0035)。与Durvalumab组结合使用,在Tremelimumab中,36个月的OS率为30.7%(95%CI,25.8至35.7),索拉非尼尼布组为20.2%(95%CI,15.8至25.1)。喜马拉雅试验表明,与Durvalumab组相结合的Tremelimumab的客观反应率(ORR)为20.1%,索拉非尼组为5.1%(优势比[OR] = 4.69; 95%CI,2.85至8.04)。与durvalumab组结合使用,从随机分组开始反应的中位时间为2.2个月(四分位间范围[IQR] 1.8至4.0个月),而索拉非尼组中的3.8个月(IQR,1.9至8.4个月)(IQR,1.9至8.4个月)。与Durvalumab结合使用的Tremelimumab的安全性与其他免疫肿瘤检查点抑制剂的已知安全性相一致,被认为是可管理的。Tremelimumab与Durvalumab结合使用,这是针对无法切除的HCC患者的未满足需求,而HCC患者的出血风险较高,而出血的风险较高,他们没有资格与Bevacizumab结合使用Atezolizumab。
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