欧狄沃辅助治疗肌层浸润性尿路上皮癌延长患者无病生存期近2倍

2021-02-09 MedSci MedSci

2021年2月8日,百时美施贵宝(NYSE: BMY) 公布了III期临床研究CheckMate -274的临床研究结果:欧狄沃(纳武利尤单抗)辅助治疗高复发风险肌层浸润性尿路上皮癌术后患者,在所有随

202128日,百时美施贵宝(NYSE: BMY 公布了III期临床研究CheckMate -274的临床研究结果:欧狄沃(纳武利尤单抗)辅助治疗高复发风险肌层浸润性尿路上皮癌术后患者,在所有随机人群和PD-L1表达≥1%患者中均达到主要研究终点,可显著改善患者无病生存期(DFS)。CheckMate -274 研究是首个评估免疫治疗作为肌层浸润性尿路上皮癌辅助治疗,并取得阳性结果的III期临床研究。

在所有随机人群中,接受欧狄沃的治疗组中位DFS[21.0个月]与安慰剂对照组中位DFS [10.9个月]相比延长近一倍;风险降低30%(风险比[HR]0.7098.31%可信区间[CI]0.540.89p<0.001)。在PD-L1表达≥1%的患者中,欧狄沃将疾病复发或死亡风险降低47%,欧狄沃治疗组与安慰剂对照组的中位DFS分别为未达到和10.8个月(风险比[HR] 0.5398.87%可信区间[CI]0.340.84p<0.001)。该研究数据将于美国东部标准时间20212121636-1646在美国临床肿瘤学会生殖泌尿系统肿瘤研讨会(ASCO-GU)上进行口头报告(摘要号#391)。

肌层浸润性尿路上皮癌患者通常需要接受膀胱切除术以挽救生命,但仍有约50%的患者会面临术后复发。纪念斯隆凯特琳癌症中心生殖泌尿肿瘤学家、医学博士Dean Bajorin表示,根据CheckMate -274 临床研究,经纳武利尤单抗治疗的患者无病生存期几乎是安慰剂组的两倍。该结果具有重大临床意义,有望改变肌层浸润性尿路上皮癌的现有治疗方式,以满足患者对术后治疗有效性与耐受性的迫切需求。

此外,欧狄沃在关键次要研究终点也显示出了疗效改善,包括非尿路上皮无复发生存期(NUTRFS 即:患者在膀胱、输尿管或肾盂以外无疾病复发的生存时间)。在所有随机人群中,经欧狄沃治疗的患者中位NUTRFS超过两年[24.6个月],安慰剂组为13.7个月(风险比[HR] 0.7295%可信区间[CI] 0.580.89)。在PD-L1表达≥1%的患者中,欧狄沃治疗组与安慰剂对照组的中位NUTRFS分别为未达到和10.9个月(风险比[HR]0.5495%可信区间[CI]0.380.77)。

在此项研究中,欧狄沃的安全性特征与其既往在其他实体瘤临床研究报道的安全性特征一致。接受欧狄沃或安慰剂治疗的患者中发生与治疗相关的不良事件(TRAEs)的比例分别为77.5%55.5%3级或4TRAEs的发生率分别为17.9%7.2%

通过将免疫治疗的应用前移至癌症早期阶段,我们将有机会干预疾病进程、减少肿瘤复发,并为患者带来更好的治疗效果,百时美施贵宝生殖泌尿肿瘤开发项目负责人,医学博士Dana Walker表示,以欧狄沃为基础的辅助治疗方案目前不仅在尿路上皮癌中显示出获益,同时还被证实可为早期黑色素瘤、食管癌和肺癌患者带来生存获益。我们非常高兴看到CheckMate -274 研究结果为肿瘤患者带来临床获益,也非常感谢所有参与试验的患者和研究人员。我们期待与全球各卫生主管部门协作,希望将该治疗方案惠及更多患者。

关于CheckMate-274

CheckMate -274是一项随机、双盲、多中心III期临床研究,旨在评估欧狄沃对比安慰剂用于根治手术后高复发风险肌层浸润性尿路上皮癌患者的疗效与安全性。患者无论术前有无接受过新辅助治疗均可入组,参与者是否接受顺铂新辅助治疗是该研究的一个分层因素。共709名患者按1:1比例进行随机分组,分别接受至多一年的每两周240mg 欧狄沃或安慰剂治疗。该研究的主要终点是所有随机患者(即意向治疗人群)和肿瘤表达PD-L1≥1%患者的无病生存期(DFS)。关键的次要终点包括总生存期(OS)、非尿路上皮无复发生存期(NUTRFS)和疾病特异性生存期(DSS)。

关于尿路上皮癌

尿路上皮癌通常起源于膀胱,是全球第十大常见肿瘤,全球每年约有55万新确诊病例。除膀胱外,尿路上皮癌还可以发生在泌尿系统的其他部位,包括输尿管和肾盂。大多数尿路上皮癌在早期即可确诊,但疾病复发率和进展率高,超过50%接受根治性切除的浸润性尿路上皮癌患者术后将面临疾病复发。复发为转移性尿路上皮癌患者预后较差,经系统治疗后的中位总生存期约为12~14个月。

关于欧狄沃

欧狄沃于20147月获批成为全球首个PD-1抑制剂,目前已在66个国家和地区获批共11个瘤种[1],涵盖肺癌、头颈癌、胃癌、食管癌、肝癌、肾癌、结直肠癌、尿路上皮癌、黑色素瘤、霍奇金淋巴瘤、胸膜肿瘤,惠及超过590,000名全球患者。

欧狄沃是中国首个获批上市的免疫肿瘤药物,目前在中国获批以下3项适应证,除此以外其他适应证尚未获批:

1 用于治疗表皮生长因子受体(EGFR)基因突变阴性和间变性淋巴瘤激酶(ALK)阴性、既往接受过含铂方案化疗后疾病进展或不可耐受的局部晚期或转移性非小细胞肺癌(NSCLC)的成人患者;

2 用于接受含铂类方案治疗期间或之后出现疾病进展且肿瘤PD-L1表达阳性(表达PD-L1的肿瘤细胞≥1%)的复发性或转移性头颈部鳞状细胞癌(SCCHN)患者;

3 用于治疗既往接受过两种或两种以上全身性治疗方案的晚期或复发性胃或胃食管连接部腺癌患者。

欧狄沃是唯一由诺贝尔生理学或医学奖得主直接参与开发的PD-1抑制剂。百时美施贵宝拥有本庶佑博士的PD-1专利独家使用权。

1:欧狄沃为基础的免疫单药治疗及免疫联合治疗方案

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  4. [GetPortalCommentsPageByObjectIdResponse(id=1376947, encodeId=e13c13e6947dc, content=<a href='/topic/show?id=4df06311110' target=_blank style='color:#2F92EE;'>#欧狄沃#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=63111, encryptionId=4df06311110, topicName=欧狄沃)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=62a7397, createdName=charl1234567, createdTime=Wed Feb 10 13:51:00 CST 2021, time=2021-02-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1378277, encodeId=d95813e8277f7, content=<a href='/topic/show?id=c29b69004f9' target=_blank style='color:#2F92EE;'>#生存期#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=18, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=69004, encryptionId=c29b69004f9, topicName=生存期)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e68e415, createdName=juliusluan78, createdTime=Wed Feb 10 13:51:00 CST 2021, time=2021-02-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1539377, encodeId=664815393e7b9, content=<a href='/topic/show?id=0e802002e45' target=_blank style='color:#2F92EE;'>#上皮癌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=20, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=20027, encryptionId=0e802002e45, topicName=上皮癌)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=866a13134648, createdName=mashirong, createdTime=Wed Feb 10 13:51:00 CST 2021, time=2021-02-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=923841, encodeId=84b6923841a3, content=与标准疗法(化疗联合西妥昔单抗)相比,durvalumab单药治疗未达到延长患者总生存期(OS)的主要终点。而联合治疗组也未显示出OS获益(次要终点)。, beContent=null, objectType=article, channel=null, level=null, likeNumber=89, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210208/c3dc2580e0ac4c8191eae47c717138a5/1e85aea19cb54b3da3746e58584795cf.jpg, createdBy=a3975411105, createdName=Half, createdTime=Tue Feb 09 08:25:39 CST 2021, time=2021-02-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=923835, encodeId=709c92383504, content=好软件,好学习途径, beContent=null, objectType=article, channel=null, level=null, likeNumber=73, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210209/9f9d94fc353a4ce9b0d9d481fc5697f8/03d0a0b2a0df4155b68722487e41e387.jpg, createdBy=9d0a1863255, createdName=ms511280326648876, createdTime=Tue Feb 09 05:45:41 CST 2021, time=2021-02-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=923816, encodeId=deed923816b3, content=不幸的消息!, beContent=null, objectType=article, channel=null, level=null, likeNumber=76, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6bed2482428, createdName=国基然, createdTime=Tue Feb 09 00:46:05 CST 2021, time=2021-02-09, status=1, ipAttribution=)]
    2021-02-09 Half

    与标准疗法(化疗联合西妥昔单抗)相比,durvalumab单药治疗未达到延长患者总生存期(OS)的主要终点。而联合治疗组也未显示出OS获益(次要终点)。

    0

  5. [GetPortalCommentsPageByObjectIdResponse(id=1376947, encodeId=e13c13e6947dc, content=<a href='/topic/show?id=4df06311110' target=_blank style='color:#2F92EE;'>#欧狄沃#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=63111, encryptionId=4df06311110, topicName=欧狄沃)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=62a7397, createdName=charl1234567, createdTime=Wed Feb 10 13:51:00 CST 2021, time=2021-02-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1378277, encodeId=d95813e8277f7, content=<a href='/topic/show?id=c29b69004f9' target=_blank style='color:#2F92EE;'>#生存期#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=18, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=69004, encryptionId=c29b69004f9, topicName=生存期)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e68e415, createdName=juliusluan78, createdTime=Wed Feb 10 13:51:00 CST 2021, time=2021-02-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1539377, encodeId=664815393e7b9, content=<a href='/topic/show?id=0e802002e45' target=_blank style='color:#2F92EE;'>#上皮癌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=20, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=20027, encryptionId=0e802002e45, topicName=上皮癌)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=866a13134648, createdName=mashirong, createdTime=Wed Feb 10 13:51:00 CST 2021, time=2021-02-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=923841, encodeId=84b6923841a3, content=与标准疗法(化疗联合西妥昔单抗)相比,durvalumab单药治疗未达到延长患者总生存期(OS)的主要终点。而联合治疗组也未显示出OS获益(次要终点)。, beContent=null, objectType=article, channel=null, level=null, likeNumber=89, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210208/c3dc2580e0ac4c8191eae47c717138a5/1e85aea19cb54b3da3746e58584795cf.jpg, createdBy=a3975411105, createdName=Half, createdTime=Tue Feb 09 08:25:39 CST 2021, time=2021-02-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=923835, encodeId=709c92383504, content=好软件,好学习途径, beContent=null, objectType=article, channel=null, level=null, likeNumber=73, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210209/9f9d94fc353a4ce9b0d9d481fc5697f8/03d0a0b2a0df4155b68722487e41e387.jpg, createdBy=9d0a1863255, createdName=ms511280326648876, createdTime=Tue Feb 09 05:45:41 CST 2021, time=2021-02-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=923816, encodeId=deed923816b3, content=不幸的消息!, beContent=null, objectType=article, channel=null, level=null, likeNumber=76, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6bed2482428, createdName=国基然, createdTime=Tue Feb 09 00:46:05 CST 2021, time=2021-02-09, status=1, ipAttribution=)]
    2021-02-09 ms511280326648876

    好软件,好学习途径

    0

  6. [GetPortalCommentsPageByObjectIdResponse(id=1376947, encodeId=e13c13e6947dc, content=<a href='/topic/show?id=4df06311110' target=_blank style='color:#2F92EE;'>#欧狄沃#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=63111, encryptionId=4df06311110, topicName=欧狄沃)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=62a7397, createdName=charl1234567, createdTime=Wed Feb 10 13:51:00 CST 2021, time=2021-02-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1378277, encodeId=d95813e8277f7, content=<a href='/topic/show?id=c29b69004f9' target=_blank style='color:#2F92EE;'>#生存期#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=18, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=69004, encryptionId=c29b69004f9, topicName=生存期)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e68e415, createdName=juliusluan78, createdTime=Wed Feb 10 13:51:00 CST 2021, time=2021-02-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1539377, encodeId=664815393e7b9, content=<a href='/topic/show?id=0e802002e45' target=_blank style='color:#2F92EE;'>#上皮癌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=20, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=20027, encryptionId=0e802002e45, topicName=上皮癌)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=866a13134648, createdName=mashirong, createdTime=Wed Feb 10 13:51:00 CST 2021, time=2021-02-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=923841, encodeId=84b6923841a3, content=与标准疗法(化疗联合西妥昔单抗)相比,durvalumab单药治疗未达到延长患者总生存期(OS)的主要终点。而联合治疗组也未显示出OS获益(次要终点)。, beContent=null, objectType=article, channel=null, level=null, likeNumber=89, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210208/c3dc2580e0ac4c8191eae47c717138a5/1e85aea19cb54b3da3746e58584795cf.jpg, createdBy=a3975411105, createdName=Half, createdTime=Tue Feb 09 08:25:39 CST 2021, time=2021-02-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=923835, encodeId=709c92383504, content=好软件,好学习途径, beContent=null, objectType=article, channel=null, level=null, likeNumber=73, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210209/9f9d94fc353a4ce9b0d9d481fc5697f8/03d0a0b2a0df4155b68722487e41e387.jpg, createdBy=9d0a1863255, createdName=ms511280326648876, createdTime=Tue Feb 09 05:45:41 CST 2021, time=2021-02-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=923816, encodeId=deed923816b3, content=不幸的消息!, beContent=null, objectType=article, channel=null, level=null, likeNumber=76, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6bed2482428, createdName=国基然, createdTime=Tue Feb 09 00:46:05 CST 2021, time=2021-02-09, status=1, ipAttribution=)]
    2021-02-09 国基然

    不幸的消息!

    0

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