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nivolumab黑色素瘤三期临床疗效明显提前终止

2014-06-27 佚名 不详

今天施贵宝宣布其PD-1抑制剂nivolumab在一个黑色素瘤的三期临床因明显改进总生存期而被提前终止。Nivolumab已获得FDA突破性药物地位,所以其审批、上市过程会相对通畅。施贵宝称将会和药监部门沟通这个结果,其股票因此上扬2%。 三期临床实验提前终止要么是非常好的消息,要么是非常坏的消息,因为除非疗效或安全性显着与预测值不同,实验得完成才能看出到底有效无效,因为实验时间就是根据预期

今天施贵宝宣布其PD-1抑制剂nivolumab在一个黑色素瘤的三期临床因明显改进总生存期而被提前终止。Nivolumab已获得FDA突破性药物地位,所以其审批、上市过程会相对通畅。施贵宝称将会和药监部门沟通这个结果,其股票因此上扬2%。

三期临床实验提前终止要么是非常好的消息,要么是非常坏的消息,因为除非疗效或安全性显着与预测值不同,实验得完成才能看出到底有效无效,因为实验时间就是根据预期疗效设定的。多数情况下临床实验提前终止是不利的消息,但今天是个例外。这无论对施贵宝还是黑色素瘤患者都是非常鼓舞人心的。施贵宝正在和默克进行一场史无前例的竞争,两个公司可以说都倾其所有争取第一个上市PD-1抑制剂。默克已经提交了滚动申请,FDA定于10月给予评审。Nivolumab的这个实验结果如果象公司宣布这样,这个产品也极有可能今年上市。

黑色素瘤是个相对小的适应症,虽然nivolumab是在晚期对其它药物无效的病人做的这个临床,但如果上市极有可能被医生标签外使用作为一线药物。在非小细胞肺癌这个更大的适应症,nivolumab比默克的pembrolizumab领先一步。如果nivolumab有效这个产品会成为NSCLC的核心疗法。即和化疗组合作为一线药物,也可和靶向药物组合用于变异肿瘤。如果其它疗法全部失败nivolumab可单独使用或和另一免疫哨卡抑制剂Yervoy合用作为最后一道防线。

药厂之间如此激烈的竞争以前似乎没有发生过。现在的支付环境只对颠覆性药物高度认同,其它新药即使是新分子药物、甚至新机理药物如果疗效没有显着改善销售也很困难。甚至有人提出一个新药如果拿不到FDA突破性药物地位就不值得开发。但颠覆性项目太少,所以一旦出现各大药厂都不遗余力地争夺地盘。患者是这个激烈角逐的最大受益者。虽然什么时候得黑色素瘤都不是好事,但现在的预后显然比以前得这个病要好的多。很多人从死神手里逃脱,走回正常的生活。PD-1抑制剂应该算作医药史上一个重要的里程碑。

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    2014-09-26 sunylz
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    2015-04-16 snf701207
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    2014-10-13 tamgche
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  6. [GetPortalCommentsPageByObjectIdResponse(id=1680246, encodeId=fa33168024691, content=<a href='/topic/show?id=9e5c86e0712' target=_blank style='color:#2F92EE;'>#色素#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=71, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=86707, encryptionId=9e5c86e0712, topicName=色素)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=343027846633, createdName=sunylz, createdTime=Fri Sep 26 07:46:00 CST 2014, time=2014-09-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1911655, encodeId=3e3119116556d, content=<a href='/topic/show?id=4de7112046c' target=_blank style='color:#2F92EE;'>#mAb#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=58, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11204, encryptionId=4de7112046c, topicName=mAb)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=25e7304, createdName=snf701207, createdTime=Thu Apr 16 23:46:00 CST 2015, time=2015-04-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2007836, encodeId=3084200e83647, content=<a href='/topic/show?id=601512826f6' target=_blank style='color:#2F92EE;'>#NIV#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=60, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12826, encryptionId=601512826f6, topicName=NIV)], attachment=null, authenticateStatus=null, createdAvatar=/v1.0.0/img/user_icon.png, createdBy=674961, createdName=tamgche, createdTime=Mon Oct 13 17:46:00 CST 2014, time=2014-10-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1991293, encodeId=594a1991293a0, content=<a href='/topic/show?id=5bd3196e127' target=_blank style='color:#2F92EE;'>#三期临床#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=60, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=19671, encryptionId=5bd3196e127, topicName=三期临床)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e9ed371, createdName=楚秀娟, createdTime=Wed Aug 06 04:46:00 CST 2014, time=2014-08-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1907143, encodeId=b4a8190e143d6, content=<a href='/topic/show?id=acc02289e40' target=_blank style='color:#2F92EE;'>#临床疗效#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=78, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=22897, encryptionId=acc02289e40, topicName=临床疗效)], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/aLGWoFXAyMbIu3qymFOyheQLjPSX3OUs5GmkyBlcCOwTPIeq3why9NGibxxUqYo6hcx8qZLHZFgNPnBK1yzWeOFpyg2OnWOt0/0, createdBy=fa4716, createdName=zhouqu_8, createdTime=Tue Dec 02 07:46:00 CST 2014, time=2014-12-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1558662, encodeId=014a155866241, content=<a href='/topic/show?id=e27610332666' target=_blank style='color:#2F92EE;'>#黑色素#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=61, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=103326, encryptionId=e27610332666, topicName=黑色素)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=150614999302, createdName=cqlidoudou, createdTime=Sun Jun 29 04:46:00 CST 2014, time=2014-06-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1564671, encodeId=46b015646e141, content=<a href='/topic/show?id=e27610332666' target=_blank style='color:#2F92EE;'>#黑色素#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=66, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=103326, encryptionId=e27610332666, topicName=黑色素)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=150614999302, createdName=cqlidoudou, createdTime=Sun Jun 29 04:46:00 CST 2014, time=2014-06-29, status=1, ipAttribution=)]
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