惊爆！Opdivo作为NSCLC一线用药试验未达终点！

2016-08-06 MedSci MedSci原创

今天，2016年8月5日，美国百时美施贵宝公司的PD-1药物Opdivo在作为针对非小细胞肺癌（NSCLC）一线用药的的三期临床试验中没有达到关键的PFS终点。其股价（BMY）大跌约20%。其竞赛对手默克/默沙东的股价大涨约10%。百时美施贵宝公布了CheckMate-026的试验结果。CheckMate-026是一个三期临床试验，研究Opdivo (nivolumab)，作为一线使用

今天，2016年8月5日，美国百时美施贵宝公司的PD-1药物Opdivo在作为针对非小细胞肺癌（NSCLC）一线用药的的三期临床试验中没有达到关键的PFS终点。其股价（BMY）大跌约20%。其竞赛对手默克/默沙东的股价大涨约10%。

百时美施贵宝公布了CheckMate-026的试验结果。CheckMate-026是一个三期临床试验，研究Opdivo (nivolumab)，作为一线使用的单药，首次治疗未接受过治疗的晚期非小细胞肺癌患者的效果。Opdivo未达到PD-L1表达等于5% 的病人的无进展生存率这一主要终点。公司将对该临床试验的数据进行完整的全面的分析，并与PI一起合作来呈现结果。

PD-L1表达等于5%，想覆盖太多的患者，但是应证一句话：步子太大，容易扯着蛋！如果Opdivo研究中也选择PD-L1表达50%及以上的患者，也许疗效会大相同，但是，临床研究中，无后悔药可吃！

百时美施贵宝的CEO，Giovanni Caforio 医学博士，评论道，“Opdivo已经成为一种基本的治疗而改变跨多个肿瘤类型的癌症治疗。虽然我们对CheckMate-026临床试验未达到终点表示遗憾，我们将继续致力于提高病人的治疗效果，通过我们广泛的开发项目，包括进行中的三期临床试验，CheckMate-227，该试验探索Opdivo与Yervoy组合用药治疗PD-L1阳性病人的潜力，以及Opdivo联合Yervoy，或Opdivo联合化疗药物治疗PD-L1阴性的病人。

默沙东的Keytruda的同样目的的三期临床试验中，他们选择的病人群体有一点不同。所选病人的PD-L1表达都很高，50%或更多。而BMS选择的病人的PD-L1表达是5%。在默沙东公布的临床试验数据中，不但达到了主要的PFS终点，同时也达到了通常更难的次要终点，总存活率（OS）。

2016年8月4日，美国制药巨头默沙东 (Merck & Co) 在研PD-1免疫疗法Keytruda近日在欧盟监管方面传来喜讯，欧盟委员会(EC)已批准Keytruda(2mg/kg，每三周一次) 用于晚期非小细胞肺癌(NSCLC)的治疗，具体为肿瘤PD-L1表达呈阳性且既往接受过至少一种化疗方案的局部晚期或转移性非小细胞肺癌(NSCLC)患者。携带EGFR或ALK阳性肿瘤突变的患者，在进行Keytruda治疗之前应已接受获批用于相应突变的疗法治疗。

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2016-08-10 明天会更好！

我会继续一直关注！希望科研工作者们继续努力，早日攻克癌症！早日解救百姓于水火！

71 0
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2016-08-07 119337457

#Opdivo#

0 0
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2016-08-07 oo902

好可惜啊，未达终点

58 0
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2016-08-06 马里奥8433

还有什么药好呢

77 0
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2016-08-06 倒置的脚印

又学到了新知识

19 0
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2016-08-06 oo902

学习了，好赞!

19 0
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2016-08-06 1dd8a7c5m95(暂无匿称)

学习了，赞一个！！

24 0
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createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/DYAIOgq83eocJY6moGTnYzC8V8lUl3k679Uxh0PVMjIamhoDYuSYr6D4KDKlbpuNuCKFlJaiaVrmFIrbseIWqUA/132, createdBy=ad571630249, createdName=马里奥8433, createdTime=Sat Aug 06 16:28:00 CST 2016, time=2016-08-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=96406, encodeId=966896406b8, content=又学到了新知识, beContent=null, objectType=article, channel=null, level=null, likeNumber=19, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/Q3auHgzwzM4FezQOHo9ib8hLIGaxJo86IicS8U0MOFotEEWY6KE26tFNFr4Fq4Lx9icG6DQwsp1TL8wMqKxMibRB8A/0, createdBy=5eac1930766, createdName=倒置的脚印, createdTime=Sat Aug 06 10:20:00 CST 2016, time=2016-08-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=96334, encodeId=dd05963343f, content=学习了，好赞!, beContent=null, objectType=article, channel=null, level=null, likeNumber=19, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=/v1.0.0/img/user_icon.png, createdBy=a37a1710612, createdName=oo902, createdTime=Sat Aug 06 09:03:00 CST 2016, time=2016-08-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=96295, encodeId=1bfa962953e, content=学习了，赞一个！！, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/mStl88fu4NfNLvzZhgPxRuUXgacXpPeW0x8Z3Qr9c3I2kTic4ZIpR29iaftYgkjRcbv982icYMtqANBPYBgPnOia6mVtX76qMXuc/0, createdBy=ebe61630855, createdName=1dd8a7c5m95(暂无匿称), createdTime=Sat Aug 06 08:47:00 CST 2016, time=2016-08-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=96294, encodeId=3b2096294d7, content=学习了，赞一个！！, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/mStl88fu4NfNLvzZhgPxRuUXgacXpPeW0x8Z3Qr9c3I2kTic4ZIpR29iaftYgkjRcbv982icYMtqANBPYBgPnOia6mVtX76qMXuc/0, createdBy=ebe61630855, createdName=1dd8a7c5m95(暂无匿称), createdTime=Sat Aug 06 08:46:00 CST 2016, time=2016-08-06, status=1, ipAttribution=)]
2016-08-06 1dd8a7c5m95(暂无匿称)

学习了，赞一个！！

24 0