J Clin Oncol:III期临床研究评估PD-1抑制剂Spartalizumab 联合Dabrafenib(达拉非尼)+ Trametinib(曲美替尼)治疗BRAF V600突变不可切除或转移性黑色素瘤的疗效

2022-01-16 yd2015 MedSci原创

研究表明,PD-1抑制剂Spartalizumab 联合Dabrafenib(达拉非尼)+ Trametinib(曲美替尼)并不能明显改善BRAF V600突变不可切除或转移性黑色素瘤患者的预后。

近期,Journal of Clinical Oncology杂志上发表了一项III期临床研究COMBI-i结果,旨在评估PD-1抑制剂Spartalizumab 联合Dabrafenib(达拉非尼)+ Trametinib(曲美替尼)治疗BRAF V600突变不可切除或转移性黑色素瘤的疗效和安全性。

COMBI-i (NCT02967692)是一项全球、随机、III期临床试验,评估抗PD-1抑制剂spartalizumab联合dabrafenib+trametinib (sparta- DabTram)对比安慰剂联合dabrafenib+trametinib (安慰剂- DabTram)的疗效和安全性。主要终点是研究者评估的无进展生存期(PFS)。次要终点包括OS,ORR、应答持续时间(DOR)、疾病控制率(DCR)和安全性。

在2017年9月13日和2018年7月4日之间,532名患者被随机分配到接受sparta- DabTram(n=267)或安慰剂- DabTram(n=265)。

在数据截止点(2020年7月1日),中位随访时间为27.2个月(四分位数区间[IQR],25.4-29.0个月)。两组的中位无进展生存期分别为16.2个月(95% CI, 12.7 - 23.9个月)和12.0个月(95% CI, 10.2 - 15.4个月),没有统计学差异 (HR, 0.82 [95% CI, 0.66 to 1.03]; P=0.042 [one-sided; nonsignificant])。两组的24个月无进展生存率分别为44% (95% CI, 37 - 50)和36% (95% CI, 30 - 42)。

              PFS和亚组分析

PD-L1和TMB状态并不能影响治疗的预后。两组的24个月的OS率分别为68% (95% CI, 61 - 73)和62% (95% CI, 55 - 67),有也没有统计学差异(HR, 0.79 [95% CI, 0.59 to 1.05])。

            PD-L1和TMB状态分层PFS分析

接受sparta-dabtram治疗患者,ORR为69%(95%CI,62.6-74.1),其中有53例(20%;95%CI: 15.2 ~ 25.1)获得完全缓解。相比之下,安慰剂组的ORR为64%(95% CI, 58.1 - 69.9),有47人(18%;95%CI,13.3 ~ 22.9)达到完全缓解。

               疗效评估

Sparta-DabTram组的中位DOR未达到(95% CI, 18.6个月-不可估计),而安慰剂-DabTram组的中位DOR为20.7个月(95% CI, 13.0个月-不可估计)。两组的24个月DOR率分别为55% (95% CI, 47 - 62)和48% (95% CI, 39 - 56)。

                两组DOR差异

两组≧3级不良反应发生率分别为≧55%(146 / 267)和33%(88 / 264)。

               AEs

综上,研究表明,PD-1抑制剂Spartalizumab 联合Dabrafenib(达拉非尼)+ Trametinib(曲美替尼)并不能明显改善BRAF V600突变不可切除或转移性黑色素瘤患者的预后。

原始出处:

Dummer R, Long GV, Robert C, Tawbi HA, Flaherty KT, Ascierto PA, Nathan PD, Rutkowski P, Leonov O, Dutriaux C, Mandalà M, Lorigan P, Ferrucci PF, Grob JJ, Meyer N, Gogas H, Stroyakovskiy D, Arance A, Brase JC, Green S, Haas T, Masood A, Gasal E, Ribas A, Schadendorf D. Randomized Phase III Trial Evaluating Spartalizumab Plus Dabrafenib and Trametinib for BRAF V600-Mutant Unresectable or Metastatic Melanoma. J Clin Oncol. 2022 Jan 14:JCO2101601. doi: 10.1200/JCO.21.01601. Epub ahead of print. PMID: 35030011.

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    2022-09-12 jklm09
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    2022-04-16 bsmagic9140
  4. 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status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1752371, encodeId=91f71e5237160, content=<a href='/topic/show?id=2cd11e738fd' target=_blank style='color:#2F92EE;'>#Trametinib#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17738, encryptionId=2cd11e738fd, topicName=Trametinib)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=0da336510503, createdName=pandamao2022, createdTime=Fri May 06 01:08:02 CST 2022, time=2022-05-06, status=1, ipAttribution=)]
    2022-10-08 snf701207
  5. 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content=<a href='/topic/show?id=4a391158248' target=_blank style='color:#2F92EE;'>#MET#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11582, encryptionId=4a391158248, topicName=MET)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=18fc139, createdName=一闲, createdTime=Wed Dec 14 17:08:02 CST 2022, time=2022-12-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1653231, encodeId=526b165323178, content=<a href='/topic/show?id=5b011018e07' target=_blank style='color:#2F92EE;'>#I期临床#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10187, encryptionId=5b011018e07, topicName=I期临床)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=fc1f24335670, createdName=医生2402, createdTime=Thu Apr 28 04:08:02 CST 2022, time=2022-04-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1752371, encodeId=91f71e5237160, content=<a href='/topic/show?id=2cd11e738fd' target=_blank style='color:#2F92EE;'>#Trametinib#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17738, encryptionId=2cd11e738fd, topicName=Trametinib)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=0da336510503, createdName=pandamao2022, createdTime=Fri May 06 01:08:02 CST 2022, time=2022-05-06, status=1, ipAttribution=)]
    2022-09-29 minlingfeng
  6. [GetPortalCommentsPageByObjectIdResponse(id=1852869, encodeId=42e21852869c8, content=<a href='/topic/show?id=f0a254918f0' target=_blank style='color:#2F92EE;'>#抑制剂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=20, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=54918, encryptionId=f0a254918f0, topicName=抑制剂)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=44a360, createdName=jklm09, createdTime=Mon Sep 12 14:08:02 CST 2022, time=2022-09-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1650047, encodeId=6a59165004e79, content=<a href='/topic/show?id=21a496002b' target=_blank style='color:#2F92EE;'>#II期临床研究#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9600, encryptionId=21a496002b, topicName=II期临床研究)], attachment=null, authenticateStatus=null, createdAvatar=null, 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content=<a href='/topic/show?id=4a391158248' target=_blank style='color:#2F92EE;'>#MET#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11582, encryptionId=4a391158248, topicName=MET)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=18fc139, createdName=一闲, createdTime=Wed Dec 14 17:08:02 CST 2022, time=2022-12-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1653231, encodeId=526b165323178, content=<a href='/topic/show?id=5b011018e07' target=_blank style='color:#2F92EE;'>#I期临床#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10187, encryptionId=5b011018e07, topicName=I期临床)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=fc1f24335670, createdName=医生2402, createdTime=Thu Apr 28 04:08:02 CST 2022, time=2022-04-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1752371, encodeId=91f71e5237160, content=<a href='/topic/show?id=2cd11e738fd' target=_blank style='color:#2F92EE;'>#Trametinib#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17738, encryptionId=2cd11e738fd, topicName=Trametinib)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=0da336510503, createdName=pandamao2022, createdTime=Fri May 06 01:08:02 CST 2022, time=2022-05-06, status=1, ipAttribution=)]
    2022-09-28 juliusluan78
  7. 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status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1752371, encodeId=91f71e5237160, content=<a href='/topic/show?id=2cd11e738fd' target=_blank style='color:#2F92EE;'>#Trametinib#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17738, encryptionId=2cd11e738fd, topicName=Trametinib)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=0da336510503, createdName=pandamao2022, createdTime=Fri May 06 01:08:02 CST 2022, time=2022-05-06, status=1, ipAttribution=)]
    2022-02-02 sunylz
  8. [GetPortalCommentsPageByObjectIdResponse(id=1852869, encodeId=42e21852869c8, content=<a href='/topic/show?id=f0a254918f0' target=_blank style='color:#2F92EE;'>#抑制剂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=20, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=54918, encryptionId=f0a254918f0, topicName=抑制剂)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=44a360, createdName=jklm09, createdTime=Mon Sep 12 14:08:02 CST 2022, time=2022-09-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1650047, encodeId=6a59165004e79, content=<a href='/topic/show?id=21a496002b' target=_blank style='color:#2F92EE;'>#II期临床研究#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9600, encryptionId=21a496002b, topicName=II期临床研究)], attachment=null, authenticateStatus=null, createdAvatar=null, 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status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1752371, encodeId=91f71e5237160, content=<a href='/topic/show?id=2cd11e738fd' target=_blank style='color:#2F92EE;'>#Trametinib#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17738, encryptionId=2cd11e738fd, topicName=Trametinib)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=0da336510503, createdName=pandamao2022, createdTime=Fri May 06 01:08:02 CST 2022, time=2022-05-06, status=1, ipAttribution=)]
    2022-12-14 一闲
  9. 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  10. 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