卡瑞利珠单抗创造肺癌最长总生存期

2020-12-20 恒瑞医药 恒瑞医药

卡瑞利珠单抗联合化疗一线治疗晚期非鳞非小细胞肺癌中位总生存期长达27.9个月。这一数据是截止目前,全球同类肺癌免疫治疗临床研究中最长的生存获益数据,成功突破了2年大关。

12月19日,全球顶尖学术期刊《柳叶刀-呼吸医学》(《THE LANCET Respiratory Medicine》)全文在线发表“卡瑞利珠单抗联合卡铂和培美曲塞对比单纯化疗一线治疗晚期非鳞非小细胞肺癌的随机、开放、多中心、III期临床试验(CameL研究)”的研究成果。

更新的生存数据显示,卡瑞利珠单抗联合化疗一线治疗晚期非鳞非小细胞肺癌中位总生存期长达27.9个月。这一数据是截止目前,全球同类肺癌免疫治疗临床研究中最长的生存获益数据,成功突破了2年大关。

为庆祝这一历史性的成就,当日下午,由同济大学附属上海市肺科医院、江苏恒瑞医药股份有限公司联合举办的卡瑞利珠单抗肺癌领域研究成果新闻发布会暨微电影《云端微光》首映式在同济大学附属上海市肺科医院隆重举行。

上海市肺科医院党委书记张雷教授、院长艾开兴教授、肿瘤科主任周彩存教授,恒瑞医药副总经理兼首席医学官邹建军女士、肿瘤事业部总经理王行远先生,《人间世》栏目组总导演秦博先生等重量级嘉宾出席。

Ø 见证——CameL研究引领免疫治疗最长生存获益

卡瑞利珠单抗CameL研究由上海市肺科医院担任牵头单位,数十家中心共同参与。对于CameL研究取得的历史性突破,艾开兴院长致以热烈祝贺。

艾开兴院长表示,上海市肺科医院作为全国领先的现代化三甲肺癌专科医院,始终积极支持我国民族创新药的研发事业,致力于高水平临床研究的设计与开展,引领肺癌诊疗的前沿进展。卡瑞利珠单抗CameL研究取得历史性的总生存数据,标志着我国肺癌免疫治疗足以比肩国际领先水平。肺科医院将与恒瑞医药等民族药企继续携手,推动更多新药、好药早日上市,让更多患者从中受益。

周彩存教授作为卡瑞利珠单抗CameL研究的leading PI向与会嘉宾介绍了该项研究的最终情况。CameL研究是一项随机、开放标签、多中心的III期临床试验,旨在中国患者人群中比较卡瑞利珠单抗联合化疗对比单纯化疗一线治疗EGFR和ALK突变阴性晚期非鳞非小细胞肺癌的疗效。

数据显示,除高达27.9个月的中位总生存期(mOS)外,卡瑞利珠单抗联合化疗一线治疗驱动基因阴性晚期非鳞非小细胞肺癌还取得了高达60.5%的客观缓解率(ORR)和长达11.3个月的中位无进展生存期(mPFS)。

周彩存教授表示,所有研究数据均表明,CameL研究的各项临床疗效评价指标均完胜当前的标准一线化疗方案,令人鼓舞。同时,CameL研究的成功也为中国专家和中国原研的合作创新提供了可借鉴的优秀案例,有助于提升中国专家做原研创新研究的信心。

Ø 绽放——卡瑞利珠单抗晚期肺鳞癌研究再传捷报

继CameL研究取得“全垒打式”成功后,卡瑞利珠单抗在更广泛肺癌患者中的探索也在继续前行,捷报频传。

会上,邹建军女士进一步介绍了卡瑞利珠单抗的另一项重磅研究——卡瑞利珠单抗联合化疗用于晚期或转移性鳞状NSCLC患者一线治疗的III期临床研究(SHR-1210-III-307)的主要研究终点结果已达到方案预设的优效标准,可显著延长患者的无进展生存期。

据悉,该研究同样由周彩存教授担任leading PI,全国54家中心共同参与。研究共入组390例受试者,按照1:1随机入组,分别接受卡瑞利珠单抗或安慰剂联合紫杉醇和卡铂,每3周给药1次,完成4或6个周期联合治疗后,进入卡瑞利珠单抗或安慰剂维持治疗,直至疾病进展、毒性不可耐受或其他需要终止治疗的情况。主要研究终点是由盲态独立中心审阅委员会(BIRC)根据RECIST v1.1标准评估的PFS。次要研究终点包括OS、研究者评估的PFS、ORR和安全性等。

此次SHR-1210-III-307研究取得阳性结果,对于广大晚期鳞状NSCLC患者来说无疑又是一大喜讯。据邹建军女士介绍,恒瑞医药已经计划于近期向NMPA药品审评中心递交上市前沟通交流申请,卡瑞利珠单抗有望成为首个覆盖鳞癌和非鳞癌非小细胞肺癌患者的国产PD-1抑制剂。

Ø 大爱——与艾携手同行,让微光照进患者的生活

伴随着CameL研究突破性结果的发布,医患纪录片《云端微光》也于现场进行首映。据悉,该片由CSCO中国临床肿瘤学会与上海电视台纪录片频道共同发起,恒瑞医药支持,《人间世》拍摄组原班人马打造,聚焦肿瘤患者的治疗与生活。同济大学附属东方医院李进教授代表CSCO基金会向影片的成功首映表示祝贺。

值得注意的是,《云端微光》其中一名患者正在上海市肺科医院进行治疗,这也让影片于肺科医院举行的首映仪式增添了别样的意义。影片以患者与癌症抗争的真实事迹为素材,演绎从患病的阴霾到与艾同行,迎接微光的感人故事,旨在通过正能量的患者故事传递,鼓励更多的癌症患者及其家庭,用原研之光点亮生命的希望。

据介绍,《云端微光》自2019年8月18日开机,历时一年时间持续跟踪拍摄。正如现场恒瑞医药肿瘤事业部总经理王行远先生,以及《人间世》栏目组总导演秦博先生所言,纪录片与新药研发虽然从事着迥异的工作,但是都怀有共同的初心——为患者谋福祉,从身体和心理两方面治疗、抚慰肿瘤患者的因疾病而造成的伤痛。

同时,与会嘉宾也呼吁全社会更多人关注肿瘤患者的治疗与生活,用各种方式帮助改善肿瘤患者的生活水平。相信通过全社会的共同努力,癌症将变得不再可怕,每一位患者都能获得幸福的人生。

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    2020-12-21 爱读书的大丽子

    卡瑞利珠单抗创造肺癌最长总生存期

    0

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    2020-12-20 jyzxjiangqin

    好文章!

    0

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