LYNPARZA(olaparib)联合贝伐单抗一线治疗HRD阳性晚期卵巢癌:已获FDA首肯

2020-05-11 Allan MedSci原创

阿斯利康(AstraZeneca)和默克(Merck)今日宣布,美国食品药品监督管理局(FDA)已批准LYNPARZA(olaparib)联合贝伐单抗一线维持治疗晚期上皮性卵巢癌。

阿斯利康(AstraZeneca)和默克(Merck)今日宣布,美国食品药品监督管理局(FDA)已批准LYNPARZA(olaparib)联合贝伐单抗一线维持治疗晚期上皮性卵巢癌、输卵管癌或原发性腹膜癌,这些患者对一线铂类化学疗法有完全或部分反应,且BRCA基因为同源重组缺陷(HRD)阳性状态。

这项批准是基于PAOLA-1 III期试验的387例HRD阳性肿瘤患者的数据分析,该研究表明LYNPARZA联合贝伐单抗可将疾病进展或死亡的风险降低67%(HR 0.33,95%CI 0.25-0.45)。对于HRD阳性的晚期卵巢癌患者,联合治疗将中位无进展生存期(PFS)提高到37.2个月,而单独使用贝伐单抗仅提高到17.7个月。

然而,与单独使用贝伐单抗的患者相比,接受LYNPARZA联合贝伐单抗的患者发生静脉血栓栓塞的可能性更高(5.0%比1.9%)。LYNPARZA联合贝伐单抗组中有54%的患者中断剂量,41%的患者降低剂量,20%的患者因不良反应终止治疗。

 

原始出处:

https://www.firstwordpharma.com/node/1722930

版权声明:
本网站所有内容来源注明为“梅斯医学”或“MedSci原创”的文字、图片和音视频资料,版权均属于梅斯医学所有。非经授权,任何媒体、网站或个人不得转载,授权转载时须注明来源为“梅斯医学”。其它来源的文章系转载文章,或“梅斯号”自媒体发布的文章,仅系出于传递更多信息之目的,本站仅负责审核内容合规,其内容不代表本站立场,本站不负责内容的准确性和版权。如果存在侵权、或不希望被转载的媒体或个人可与我们联系,我们将立即进行删除处理。
在此留言
评论区 (5)
#插入话题
  1. [GetPortalCommentsPageByObjectIdResponse(id=1633987, encodeId=e437163398e8e, content=<a href='/topic/show?id=9f0313304b2' target=_blank style='color:#2F92EE;'>#olaparib#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13304, encryptionId=9f0313304b2, topicName=olaparib)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=ffe222060531, createdName=刘阔, createdTime=Wed Aug 05 02:32:48 CST 2020, time=2020-08-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1734677, encodeId=f6061e34677fe, content=<a href='/topic/show?id=2239106951c' target=_blank style='color:#2F92EE;'>#LAP#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10695, encryptionId=2239106951c, topicName=LAP)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=06de33803044, createdName=LSJ122, createdTime=Fri Jul 17 11:32:48 CST 2020, time=2020-07-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1338215, encodeId=cd941338215bb, content=<a href='/topic/show?id=cd2a262068' target=_blank style='color:#2F92EE;'>#APA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=43, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2620, encryptionId=cd2a262068, topicName=APA)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ce072500140, createdName=12498b3em08(暂无昵称), createdTime=Wed May 13 00:32:48 CST 2020, time=2020-05-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1394570, encodeId=687013945e005, content=<a href='/topic/show?id=2c9a5981483' target=_blank style='color:#2F92EE;'>#晚期卵巢癌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=57, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=59814, encryptionId=2c9a5981483, topicName=晚期卵巢癌)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdqq.qlogo.cn/qqapp/101296147/385F510BDFE0F55A4FFDFDFFD9892943/100, createdBy=a3262500163, createdName=siiner, createdTime=Wed May 13 00:32:48 CST 2020, time=2020-05-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1477053, encodeId=c20c14e70535b, content=<a href='/topic/show?id=c32e9220221' target=_blank style='color:#2F92EE;'>#贝伐#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=92202, encryptionId=c32e9220221, topicName=贝伐)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ef557344179, createdName=sunrural_42825359, createdTime=Wed May 13 00:32:48 CST 2020, time=2020-05-13, status=1, ipAttribution=)]
    2020-08-05 刘阔
  2. [GetPortalCommentsPageByObjectIdResponse(id=1633987, encodeId=e437163398e8e, content=<a href='/topic/show?id=9f0313304b2' target=_blank style='color:#2F92EE;'>#olaparib#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13304, encryptionId=9f0313304b2, topicName=olaparib)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=ffe222060531, createdName=刘阔, createdTime=Wed Aug 05 02:32:48 CST 2020, time=2020-08-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1734677, encodeId=f6061e34677fe, content=<a href='/topic/show?id=2239106951c' target=_blank style='color:#2F92EE;'>#LAP#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10695, encryptionId=2239106951c, topicName=LAP)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=06de33803044, createdName=LSJ122, createdTime=Fri Jul 17 11:32:48 CST 2020, time=2020-07-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1338215, encodeId=cd941338215bb, content=<a href='/topic/show?id=cd2a262068' target=_blank style='color:#2F92EE;'>#APA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=43, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2620, encryptionId=cd2a262068, topicName=APA)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ce072500140, createdName=12498b3em08(暂无昵称), createdTime=Wed May 13 00:32:48 CST 2020, time=2020-05-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1394570, encodeId=687013945e005, content=<a href='/topic/show?id=2c9a5981483' target=_blank style='color:#2F92EE;'>#晚期卵巢癌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=57, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=59814, encryptionId=2c9a5981483, topicName=晚期卵巢癌)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdqq.qlogo.cn/qqapp/101296147/385F510BDFE0F55A4FFDFDFFD9892943/100, createdBy=a3262500163, createdName=siiner, createdTime=Wed May 13 00:32:48 CST 2020, time=2020-05-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1477053, encodeId=c20c14e70535b, content=<a href='/topic/show?id=c32e9220221' target=_blank style='color:#2F92EE;'>#贝伐#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=92202, encryptionId=c32e9220221, topicName=贝伐)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ef557344179, createdName=sunrural_42825359, createdTime=Wed May 13 00:32:48 CST 2020, time=2020-05-13, status=1, ipAttribution=)]
    2020-07-17 LSJ122
  3. [GetPortalCommentsPageByObjectIdResponse(id=1633987, encodeId=e437163398e8e, content=<a href='/topic/show?id=9f0313304b2' target=_blank style='color:#2F92EE;'>#olaparib#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13304, encryptionId=9f0313304b2, topicName=olaparib)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=ffe222060531, createdName=刘阔, createdTime=Wed Aug 05 02:32:48 CST 2020, time=2020-08-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1734677, encodeId=f6061e34677fe, content=<a href='/topic/show?id=2239106951c' target=_blank style='color:#2F92EE;'>#LAP#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10695, encryptionId=2239106951c, topicName=LAP)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=06de33803044, createdName=LSJ122, createdTime=Fri Jul 17 11:32:48 CST 2020, time=2020-07-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1338215, encodeId=cd941338215bb, content=<a href='/topic/show?id=cd2a262068' target=_blank style='color:#2F92EE;'>#APA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=43, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2620, encryptionId=cd2a262068, topicName=APA)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ce072500140, createdName=12498b3em08(暂无昵称), createdTime=Wed May 13 00:32:48 CST 2020, time=2020-05-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1394570, encodeId=687013945e005, content=<a href='/topic/show?id=2c9a5981483' target=_blank style='color:#2F92EE;'>#晚期卵巢癌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=57, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=59814, encryptionId=2c9a5981483, topicName=晚期卵巢癌)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdqq.qlogo.cn/qqapp/101296147/385F510BDFE0F55A4FFDFDFFD9892943/100, createdBy=a3262500163, createdName=siiner, createdTime=Wed May 13 00:32:48 CST 2020, time=2020-05-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1477053, encodeId=c20c14e70535b, content=<a href='/topic/show?id=c32e9220221' target=_blank style='color:#2F92EE;'>#贝伐#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=92202, encryptionId=c32e9220221, topicName=贝伐)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ef557344179, createdName=sunrural_42825359, createdTime=Wed May 13 00:32:48 CST 2020, time=2020-05-13, status=1, ipAttribution=)]
  4. [GetPortalCommentsPageByObjectIdResponse(id=1633987, encodeId=e437163398e8e, content=<a href='/topic/show?id=9f0313304b2' target=_blank style='color:#2F92EE;'>#olaparib#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13304, encryptionId=9f0313304b2, topicName=olaparib)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=ffe222060531, createdName=刘阔, createdTime=Wed Aug 05 02:32:48 CST 2020, time=2020-08-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1734677, encodeId=f6061e34677fe, content=<a href='/topic/show?id=2239106951c' target=_blank style='color:#2F92EE;'>#LAP#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10695, encryptionId=2239106951c, topicName=LAP)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=06de33803044, createdName=LSJ122, createdTime=Fri Jul 17 11:32:48 CST 2020, time=2020-07-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1338215, encodeId=cd941338215bb, content=<a href='/topic/show?id=cd2a262068' target=_blank style='color:#2F92EE;'>#APA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=43, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2620, encryptionId=cd2a262068, topicName=APA)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ce072500140, createdName=12498b3em08(暂无昵称), createdTime=Wed May 13 00:32:48 CST 2020, time=2020-05-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1394570, encodeId=687013945e005, content=<a href='/topic/show?id=2c9a5981483' target=_blank style='color:#2F92EE;'>#晚期卵巢癌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=57, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=59814, encryptionId=2c9a5981483, topicName=晚期卵巢癌)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdqq.qlogo.cn/qqapp/101296147/385F510BDFE0F55A4FFDFDFFD9892943/100, createdBy=a3262500163, createdName=siiner, createdTime=Wed May 13 00:32:48 CST 2020, time=2020-05-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1477053, encodeId=c20c14e70535b, content=<a href='/topic/show?id=c32e9220221' target=_blank style='color:#2F92EE;'>#贝伐#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=92202, encryptionId=c32e9220221, topicName=贝伐)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ef557344179, createdName=sunrural_42825359, createdTime=Wed May 13 00:32:48 CST 2020, time=2020-05-13, status=1, ipAttribution=)]
  5. [GetPortalCommentsPageByObjectIdResponse(id=1633987, encodeId=e437163398e8e, content=<a href='/topic/show?id=9f0313304b2' target=_blank style='color:#2F92EE;'>#olaparib#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13304, encryptionId=9f0313304b2, topicName=olaparib)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=ffe222060531, createdName=刘阔, createdTime=Wed Aug 05 02:32:48 CST 2020, time=2020-08-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1734677, encodeId=f6061e34677fe, content=<a href='/topic/show?id=2239106951c' target=_blank style='color:#2F92EE;'>#LAP#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10695, encryptionId=2239106951c, topicName=LAP)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=06de33803044, createdName=LSJ122, createdTime=Fri Jul 17 11:32:48 CST 2020, time=2020-07-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1338215, encodeId=cd941338215bb, content=<a href='/topic/show?id=cd2a262068' target=_blank style='color:#2F92EE;'>#APA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=43, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2620, encryptionId=cd2a262068, topicName=APA)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ce072500140, createdName=12498b3em08(暂无昵称), createdTime=Wed May 13 00:32:48 CST 2020, time=2020-05-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1394570, encodeId=687013945e005, content=<a href='/topic/show?id=2c9a5981483' target=_blank style='color:#2F92EE;'>#晚期卵巢癌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=57, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=59814, encryptionId=2c9a5981483, topicName=晚期卵巢癌)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdqq.qlogo.cn/qqapp/101296147/385F510BDFE0F55A4FFDFDFFD9892943/100, createdBy=a3262500163, createdName=siiner, createdTime=Wed May 13 00:32:48 CST 2020, time=2020-05-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1477053, encodeId=c20c14e70535b, content=<a href='/topic/show?id=c32e9220221' target=_blank style='color:#2F92EE;'>#贝伐#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=92202, encryptionId=c32e9220221, topicName=贝伐)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ef557344179, createdName=sunrural_42825359, createdTime=Wed May 13 00:32:48 CST 2020, time=2020-05-13, status=1, ipAttribution=)]

相关资讯

NEJM:二次手术不能延长铂敏感的复发性卵巢癌患者生存期

研究认为,对于铂敏感的复发性卵巢癌患者,与单纯化疗相比,继发性细胞减少手术联合化疗无法延长患者总生存期

J Clin Oncol:2型神经纤维瘤病和进行性前庭神经鞘瘤高剂量贝伐单抗诱导治疗的多中心、前瞻性、阶段II和生物标记研究

每3周进行7.5mg/kg的贝伐单抗治疗能够改善35%-40%的2型神经纤维瘤病和进行性前庭神经鞘瘤患者的听力情况。然而,最优剂量仍旧未知。在一个多中心阶段II和生物标记研究中,研究人员评估了高剂量贝伐单抗在2型神经纤维瘤病(NF2)及携带进行性前庭神经鞘瘤(VSs)儿童和成人患者中的效果和安全性情况。研究包括了22名携带渐进性听力损失的NF2患者(平均年龄为23岁),靶标耳朵平均基线言语识别率为

Clin cancer res:FTD/TPI+伊立替康+贝伐单抗联合治疗晚期消化道肿瘤的疗效和安全性

FTD/TPI+伊立替康+贝伐单抗联合治疗转移性结直肠癌(mCRC)的安全性、药物动力学和FTD抗肿瘤活性目前尚不明确。

NEJM:奥拉帕尼联合贝伐单抗一线治疗晚期卵巢癌

奥拉帕尼联合贝伐单抗一线治疗晚期卵巢癌效果显著

因具有感染风险,美国AmEx药房自愿召回贝伐单抗

AmEx Pharmacy宣布主动召回所有贝伐单抗1.25mg / 0.05mL 31G注射剂和2.5mg /0.1ml Normject TB注射剂,这些注射剂均处于保质期以内。在FDA检查后,这些批次被大量谨慎地召回。

J Clin Oncol:III期试验:培美曲塞联合贝伐单抗作为NSCLC患者的维持疗法的有效性和安全性

既往研究表明非小细胞肺癌(NSCLC)患者可从维持治疗中获益。COMPASS试验评估了贝伐单抗联合或不联合培美曲塞作为卡铂+培美曲塞和贝伐单抗诱导化疗后的维持治疗的有效性和安全性。COMPASS试验招募明确无EGFR 19缺失或L858R突变的未治疗过的晚期非鳞状NSCLC患者,予以卡铂、培美曲塞(500mg/m2)和贝伐单抗(15mg/kg)作为一线治疗,每3周用药一次,共4个疗程。在诱导治疗过

拓展阅读

2023 ASCO丨孙阳教授点评:晚期卵巢癌新辅助化疗相关探索

为了更好解读本次ASCO会议有关卵巢癌新辅助化疗相关研究的意义,妇产科在线邀请福建省肿瘤医院妇科肿瘤外科孙阳教授进行点评。

PARP 抑制剂 Rubraca (rucaparib)一线治疗晚期卵巢癌,显著延长了PFS

在 HRD 阴性患者的探索性亚组中,Rubraca 组患者的中位 PFS 为 12.1 个月,而安慰剂组为 9.1 个月。

Lancet Oncology:3期SOLO1试验:奥拉帕利维持治疗显著改善了晚期卵巢癌伴BRCA突变铂类化疗后患者的无进展生存期

在开始PRPP抑制剂治疗前,大多数晚期卵巢癌患者已经完成卡铂联合紫杉醇的一线化疗并对其有反应,因此没有癌症相关症状。

晚期卵巢癌的治疗取得新进展,GEN-1在I / II期临床中取得喜人结果!

OVATION 2研究结果显示,与对照组(仅护理标准)相比,治疗组(护理标准+ GEN-1)将患者的无进展生存期提高了33%。

FDA扩展PARP抑制剂Zejula的适应症,用作晚期卵巢癌的一线维持治疗

与安慰剂相比,Zejula治疗组患者的疾病发展或死亡风险降低了38%。