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Imfinzi联合tremelimumab治疗肝癌,III期试验显示可提高总体生存率

2021-10-15 Allan MedSci原创

阿斯利康的药物组合Imfinzi联合tremelimumab已被证明可显著提高一线不可切除肝癌患者的总生存期。

阿斯利康的药物组合Imfinzi联合tremelimumab已被证明可显著提高一线不可切除肝癌患者的总生存期。积极的高水平结果表明,与索拉非尼相比,添加到Imfinzi中的tremelimumab显示出具有统计学和临床​​意义的总生存期改善。

试验中的患者是那些之前未接受全身治疗且不符合局部治疗条件的不可切除肝细胞癌 (HCC) 患者。HCC是成年人中最常见类型的慢性肝癌,并且在肝硬化的患者中也是最常见的死亡原因。它发生在慢性肝脏炎症的环境中,并且与慢性病毒性肝炎感染(乙型肝炎或丙型肝炎)、酒精或毒素(如黄曲毒素)等接触相关性极高。某些疾病,如血色素沉着症和α1-抗胰蛋白酶缺乏症,也会显著增加发展为肝细胞癌的风险。代谢综合症和非酒精性脂肪肝也被越来越多地认定为肝细胞癌的危险因素。

HCC是最常见的肝癌类型,是癌症死亡的第三大原因,也是全球第六大最常见的癌症。每年约有 900,000人被诊断出患有肝癌,只有 7%的晚期患者能存活五年。

Tremelimumab是一种人类单克隆抗体和潜在的新药,能够靶向细胞毒性T淋巴细胞相关蛋白4 (CTLA-4) 。Tremelimumab阻断CTLA-4的活性,促进T细胞活化,引发对癌症的免疫反应并促进癌细胞死亡。Imfinzi (durvalumab) 是一种人类单克隆抗体,可与PD-L1蛋白结合并阻断PD-L1与PD-1和CD80蛋白的相互作用,对抗肿瘤的免疫逃避。

Ghassan Abou-Alfa,医学博士,MBA,纪念斯隆凯特琳癌症中心的主治医师和HIMALAYA III 期试验的首席研究员称:“HIMALAYA是第一个将新型单次启动剂量的抗CTLA4抗体添加到另一检查点抑制剂治疗HCC的III期临床试验。抗CTLA4抗体有助于增强患者自身对肝癌的免疫反应,旨在最大限度地延长长期生存率,同时将副作用降至最低”。

HIMALAYA III 期试验的数据将在即将举行的医学会议上公布。

Imfinzi和tremelimumab均于2020年在美国获得了治疗 HCC 的孤儿药指定,而后者在同年在欧盟获得了孤儿药指定。

 

原始出处:

http://www.pharmatimes.com/news/phase_iii_trial_shows_azs_liver_cancer_combination_improves_overall_survival_1380968

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    2021-11-19 juliusluan78
  4. 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time=2022-09-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1912699, encodeId=076119126991e, content=<a href='/topic/show?id=4de7112046c' target=_blank style='color:#2F92EE;'>#mAb#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=60, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11204, encryptionId=4de7112046c, topicName=mAb)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=25e7304, createdName=snf701207, createdTime=Fri Apr 22 23:42:18 CST 2022, time=2022-04-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1256858, encodeId=f1a81256858ad, content=<a href='/topic/show?id=43706900963' target=_blank style='color:#2F92EE;'>#生存率#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=48, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=69009, encryptionId=43706900963, topicName=生存率)], attachment=null, authenticateStatus=null, 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topicId=null, topicList=[TopicDto(id=9760, encryptionId=93ce9e60cc, topicName=Imfinzi)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=34be3191285, createdName=swallow, createdTime=Sun Oct 17 13:42:18 CST 2021, time=2021-10-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1594933, encodeId=ef9515949333c, content=<a href='/topic/show?id=b317956200' target=_blank style='color:#2F92EE;'>#III期#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=66, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9562, encryptionId=b317956200, topicName=III期)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=智智灵药, createdTime=Sun Oct 17 13:42:18 CST 2021, time=2021-10-17, status=1, ipAttribution=)]
  5. [GetPortalCommentsPageByObjectIdResponse(id=1796398, encodeId=396a1e96398ae, content=<a href='/topic/show?id=9a1b1e7916c' target=_blank style='color:#2F92EE;'>#TREM#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=108, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17791, encryptionId=9a1b1e7916c, topicName=TREM)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdqq.qlogo.cn/qqapp/101296147/4E6244DB7C1860858424437821E08291/100, createdBy=a6a52500039, createdName=ms3994565386320060, createdTime=Fri Sep 16 15:42:18 CST 2022, time=2022-09-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1947768, encodeId=62c6194e7685f, content=<a href='/topic/show?id=24ef96066d' target=_blank style='color:#2F92EE;'>#II期试验#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=73, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9606, encryptionId=24ef96066d, 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time=2022-09-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1912699, encodeId=076119126991e, content=<a href='/topic/show?id=4de7112046c' target=_blank style='color:#2F92EE;'>#mAb#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=60, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11204, encryptionId=4de7112046c, topicName=mAb)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=25e7304, createdName=snf701207, createdTime=Fri Apr 22 23:42:18 CST 2022, time=2022-04-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1256858, encodeId=f1a81256858ad, content=<a href='/topic/show?id=43706900963' target=_blank style='color:#2F92EE;'>#生存率#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=48, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=69009, encryptionId=43706900963, topicName=生存率)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6a6043, createdName=guoyibin, createdTime=Sun Oct 17 13:42:18 CST 2021, time=2021-10-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1353211, encodeId=0c121353211da, content=<a href='/topic/show?id=ba5c1e796cf' target=_blank style='color:#2F92EE;'>#Tremelimumab#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=71, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17796, encryptionId=ba5c1e796cf, topicName=Tremelimumab)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=zhaojie88, createdTime=Sun Oct 17 13:42:18 CST 2021, time=2021-10-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1416502, encodeId=59871416502ae, content=<a href='/topic/show?id=93ce9e60cc' target=_blank style='color:#2F92EE;'>#Imfinzi#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=74, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9760, encryptionId=93ce9e60cc, topicName=Imfinzi)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=34be3191285, createdName=swallow, createdTime=Sun Oct 17 13:42:18 CST 2021, time=2021-10-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1594933, encodeId=ef9515949333c, content=<a href='/topic/show?id=b317956200' target=_blank style='color:#2F92EE;'>#III期#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=66, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9562, encryptionId=b317956200, topicName=III期)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=智智灵药, createdTime=Sun Oct 17 13:42:18 CST 2021, time=2021-10-17, status=1, ipAttribution=)]
    2022-09-14 tongyongming
  6. [GetPortalCommentsPageByObjectIdResponse(id=1796398, encodeId=396a1e96398ae, content=<a href='/topic/show?id=9a1b1e7916c' target=_blank style='color:#2F92EE;'>#TREM#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=108, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17791, encryptionId=9a1b1e7916c, topicName=TREM)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdqq.qlogo.cn/qqapp/101296147/4E6244DB7C1860858424437821E08291/100, createdBy=a6a52500039, createdName=ms3994565386320060, createdTime=Fri Sep 16 15:42:18 CST 2022, time=2022-09-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1947768, encodeId=62c6194e7685f, content=<a href='/topic/show?id=24ef96066d' target=_blank style='color:#2F92EE;'>#II期试验#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=73, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9606, encryptionId=24ef96066d, 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time=2022-09-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1912699, encodeId=076119126991e, content=<a href='/topic/show?id=4de7112046c' target=_blank style='color:#2F92EE;'>#mAb#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=60, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11204, encryptionId=4de7112046c, topicName=mAb)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=25e7304, createdName=snf701207, createdTime=Fri Apr 22 23:42:18 CST 2022, time=2022-04-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1256858, encodeId=f1a81256858ad, content=<a href='/topic/show?id=43706900963' target=_blank style='color:#2F92EE;'>#生存率#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=48, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=69009, encryptionId=43706900963, topicName=生存率)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6a6043, createdName=guoyibin, createdTime=Sun Oct 17 13:42:18 CST 2021, time=2021-10-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1353211, encodeId=0c121353211da, content=<a href='/topic/show?id=ba5c1e796cf' target=_blank style='color:#2F92EE;'>#Tremelimumab#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=71, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17796, encryptionId=ba5c1e796cf, topicName=Tremelimumab)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=zhaojie88, createdTime=Sun Oct 17 13:42:18 CST 2021, time=2021-10-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1416502, encodeId=59871416502ae, content=<a href='/topic/show?id=93ce9e60cc' target=_blank style='color:#2F92EE;'>#Imfinzi#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=74, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9760, encryptionId=93ce9e60cc, topicName=Imfinzi)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=34be3191285, createdName=swallow, createdTime=Sun Oct 17 13:42:18 CST 2021, time=2021-10-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1594933, encodeId=ef9515949333c, content=<a href='/topic/show?id=b317956200' target=_blank style='color:#2F92EE;'>#III期#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=66, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9562, encryptionId=b317956200, topicName=III期)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=智智灵药, createdTime=Sun Oct 17 13:42:18 CST 2021, time=2021-10-17, status=1, ipAttribution=)]
    2022-04-22 snf701207
  7. 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  8. 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    2021-10-17 swallow
  10. 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阿斯利康近日宣布,在III期MYSTIC研究中,与标准铂类化疗相比,PD-L1抑制剂Imfinzi(durvalumab)作为单药疗法及与抗CTLA4抗体tremelimumab的联合使用未能显著提高初治IV期非小细胞肺癌(NSCLC)患者的总生存期(OS)。

durvalumab与tremelimumab的组合未能在NSCLC研究中击败化疗

阿斯利康近日宣布,与标准铂类化疗相比,Imfinzi(durvalumab)联合使用tremelimumab治疗初治IV期非小细胞肺癌(NSCLC)患者的III期NEPTUNE研究未能达到总生存期(OS)的主要终点。

阿斯利康的Imfinzi无法提高头颈癌患者的总体生存率

阿斯利康的Imfinzi在第二次试验中仍未能改善复发或转移性头颈部鳞状细胞癌(HNSCC)患者的总体生存期(OS)。

Clin Cancer Res:Durvalumab+Tremelimumab+放疗用于错配修复正常的转移性结直肠癌的疗效

在错配修复熟练(MMR-P)的转移性结直肠癌(mCRC)中,单用免疫检查点抑制剂(ICI)并不能获得预期疗效,单用放疗(RT)也不能带来客观的全身益处,两者联用是否会带来不一样的结局呢?

Lancet respir med:Tremelimumab(抗CTLA4单克隆抗体)联合durvalumab(抗PD-L1单克隆抗体)用于间皮瘤的疗效和安全性

Tremelimumab,抗CTLA4单克隆抗体,最初单独用于间皮瘤患者活性良好,但不能提高DETERMINE研究中一线或二线化疗失败的患者的总体存活率(与安慰剂对比)。现研究人员对Tremelimumab联合durvalumab(抗PD-L1单克隆抗体),作为一线或二线疗法,用于恶性间皮瘤的疗效和安全性进行评估。研究人员开展一开放性、非随机的临床II期试验,招募不可手术切除的胸膜或腹膜间皮瘤,予

J Clin Oncol:Tremelimumab 联合Durvalumab治疗不可切除肝细胞癌安全性和疗效:随机I/II期研究

研究表明四个治疗组均显示出良好耐受性和临床疗效,但是T300+D组显示更好的疗效-风险性价比,值得进一步的探讨。

拓展阅读

Imfinzi联合tremelimumab在肝癌中显示出延长OS的益处

阿斯利康表示,使用 STRIDE 方案的患者中位生存时间为 16.4 个月,而索拉非尼组为 13.8 个月。此外,估计有 40.5% 接受 STRIDE 的患者在两年内仍然存活,而索拉非尼组的这一比例

J Clin Oncol:Tremelimumab 联合Durvalumab治疗不可切除肝细胞癌安全性和疗效:随机I/II期研究

研究表明四个治疗组均显示出良好耐受性和临床疗效,但是T300+D组显示更好的疗效-风险性价比,值得进一步的探讨。

阿斯利康的Imfinzi无法提高头颈癌患者的总体生存率

阿斯利康的Imfinzi在第二次试验中仍未能改善复发或转移性头颈部鳞状细胞癌(HNSCC)患者的总体生存期(OS)。

Clin Cancer Res:Durvalumab+Tremelimumab+放疗用于错配修复正常的转移性结直肠癌的疗效

在错配修复熟练(MMR-P)的转移性结直肠癌(mCRC)中,单用免疫检查点抑制剂(ICI)并不能获得预期疗效,单用放疗(RT)也不能带来客观的全身益处,两者联用是否会带来不一样的结局呢?

durvalumab与tremelimumab的组合未能在NSCLC研究中击败化疗

阿斯利康近日宣布,与标准铂类化疗相比,Imfinzi(durvalumab)联合使用tremelimumab治疗初治IV期非小细胞肺癌(NSCLC)患者的III期NEPTUNE研究未能达到总生存期(OS)的主要终点。

MYSTIC研究:durvalumab与tremelimumab联用无法显著提高肺癌患者的生存率

阿斯利康近日宣布,在III期MYSTIC研究中,与标准铂类化疗相比,PD-L1抑制剂Imfinzi(durvalumab)作为单药疗法及与抗CTLA4抗体tremelimumab的联合使用未能显著提高初治IV期非小细胞肺癌(NSCLC)患者的总生存期(OS)。

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