信达生物公布信迪利单抗联合贝伐珠单抗一线治疗肝癌III期临床研究结果

2020-11-23 生物探索 生物探索

达伯舒®联合达攸同®疗法有望为无法切除或转移性肝癌患者一线治疗提供新的选择。

2020年11月21日,信达生物制药(香港联交所股票代码:01801)在2020年欧洲肿瘤内科学会亚洲年会(ESMO ASIA)线上会议以优选口头报告形式公布了ORIENT-32的临床研究结果,旗下达伯舒?联合达攸同?能够显着延长肝癌患者总生存期(OS)和无进展生存期(PFS)。

肝癌是全世界范围内常见的消化系统恶性肿瘤,中国的肝癌患者占全球数量的一半左右,肝癌严重地威胁着我国人民的生命和健康。肝癌的病理类型主要是肝细胞癌(HCC),占85%~90%;还有少数为肝内胆管癌(ICC)和HCC-ICC 混合型等。在我国,HCC主要由乙型肝炎病毒和/或丙型肝炎病毒感染引起。

ORIENT-32是一项比较达伯舒?联合达攸同?与索拉非尼在晚期肝癌一线治疗中的疗效和安全性的随机、对照、开放的多中心III期临床研究(ClinicalTrials.gov, NCT 03794440),也是全球首个达到主要研究终点的PD-1抑制剂联合治疗用于晚期以乙型肝炎病毒(HBV)相关肝癌为主要人群的一线治疗随机、开放、多中心III期研究。

在该研究中,共入组571例受试者,按照2:1随机入组,分别接受达伯舒?联合达攸同?或索拉非尼进行治疗。主要研究终点是OS和由独立影像学评审委员会(IRRC)根据RECIST v1.1标准评估的无进展生存期PFS。

基于独立数据监察委员会(IDMC)进行的期中分析,达伯舒?(信迪利单抗注射液)联合达攸同?(贝伐珠单抗注射液)对比索拉非尼单药治疗,显着延长了总生存期(OS)和无进展生存期(PFS),达到预设的优效性标准。

与索拉非尼组相比,达伯舒?联合达攸同?组死亡风险下降43.1% (HR 0.569, 95%CI: 0.431-0.751, P<0.0001);达伯舒?联合达攸同?组中位OS尚未达到,索拉非尼组中位OS为10.4个月。由独立影像委员会(IRRC)基于RECIST 1.1评估的疾病进展风险下降43.5%,达伯舒?联合达攸同?组中位PFS为4.6个月,索拉非尼组中位PFS为2.8个月。亚组分析结果显示所有亚组联合治疗组均获益。

联合治疗方案具有可接受的安全性,无新的安全性信号。达伯舒?联合达攸同?疗法有望为无法切除或转移性肝癌患者一线治疗提供新的选择。

信达生物制药集团医学科学与战略肿瘤部副总裁周辉博士表示:“我们非常高兴地看到研究证实了达伯舒?联合达攸同?在中国晚期肝癌一线治疗的人群中显着延长了OS和PFS。我们将尽快向国家药品监督管理局申请达伯舒?联合达攸同?的新适应症上市,让这一治疗方案惠及更多肝癌患者。”

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  5. 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topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20201120/5008534db22c474a844fbd107ff83af2/d3e20fc133b542208ff15e7f2b575329.jpg, createdBy=c7015311102, createdName=Jessie Zhang, createdTime=Thu Nov 26 15:18:36 CST 2020, time=2020-11-26, status=1, ipAttribution=)]
    2020-12-12 juliusluan78
  6. 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  7. 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topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20201120/5008534db22c474a844fbd107ff83af2/d3e20fc133b542208ff15e7f2b575329.jpg, createdBy=c7015311102, createdName=Jessie Zhang, createdTime=Thu Nov 26 15:18:36 CST 2020, time=2020-11-26, status=1, ipAttribution=)]
    2020-12-27 oo902

    ORIENT-32

    0

  8. 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topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20201120/5008534db22c474a844fbd107ff83af2/d3e20fc133b542208ff15e7f2b575329.jpg, createdBy=c7015311102, createdName=Jessie Zhang, createdTime=Thu Nov 26 15:18:36 CST 2020, time=2020-11-26, status=1, ipAttribution=)]
    2020-12-27 oo902

    信迪利单抗联合贝伐珠单抗

    0

  9. 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    2020-11-26 Jessie Zhang

    肝癌是全世界范围内常见的消化系统恶性肿瘤,中国的肝癌患者占全球数量的一半左右,肝癌严重地威胁着我国人民的生命和健康。提到肿瘤就莫名的恐惧。。。

    0

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肝细胞癌(HCC)作为全球癌症相关死亡的主要原因之一,HCC患者的5年生存率仅为15%,超过80%的HCC患者确诊时已为晚期且伴随着不良的预后。越来越多的证据表明,肝癌的发生不仅与遗传和基因组的改变相

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我们常常说,得了癌症并不意味着死亡,很多癌症即便是晚期也是可以被治愈的,然而很多患者却在听到自己患癌后便一蹶不振,整日陷入到无尽的悲观情绪中,这样也不利于病情的控制和身体的恢复。

全球肝癌患者中,中国人占一半!4种治疗方式,可以提高生存率

“我大伯上星期被查出来肝癌,是初期,但我们还是比较担心,医生说要尽早治疗,否则很容易发展成晚期,都说到了晚期神仙都治不了,那么,肝癌从初期到晚期要多少时间呢?