J Immunother Cancer: IDO抑制剂indoximod联合PD1抑制剂帕博利珠单抗(pembrolizumab)治疗晚期黑色素瘤的疗效和安全性

2021-06-15 yd2015 MedSci原创

研究表明IDO抑制剂indoximod联合PD1抑制剂帕博利珠单抗(pembrolizumab)治疗晚期黑色素瘤有疗效且毒性可控,未来值得进一步探索。

免疫检查点抑制剂常用于晚期黑色素瘤的治疗,比如常用的有CTLA4和PD1抑制剂。两者的联合能够获得大约58%的客观缓解率(ORR),但是3/4级的不良事件也明显增加。吲哚胺-2,3双加氧酶(indoleamine 2,3-dioxygenase,IDO)通路参与免疫逃逸。证据表明IDO通路的激活可增强免疫检查点的免疫抑制作用。临床前研究提示IDO通路抑制联合免疫检查点抑制剂可能增强抗肿瘤效应。因此,来自美国研究团队开展了一项II期研究,评估IDO抑制剂indoximod联合PD1抑制剂帕博利珠单抗(pembrolizumab)治疗晚期黑色素瘤的疗效和安全性。相关研究成果发表在Journal for ImmunoTherapy of Cancer杂志上。

该研究为单臂的II期研究,免疫检查点抑制剂包括pembrolizumab (P), nivolumab (N), or ipilimumab(I)。使用剂量为批准的标准剂量。Indoximod剂量为1200 mg,口服,2次/天。主要研究终点为ORR,次要终点为PFS,疾病控制率(DCR),持续缓解时间(DoR)和OS。

研究纳入131例患者,114例(87%)患者使用了帕博利珠单抗(pembrolizumab)。最终疗效可评估人群包括89例非眼的黑色素瘤患者,其接受帕博利珠单抗联合indoximod。中位年龄为61.5岁(27–88 years),56例患者(63%)为男性。4例患者(4%) 为不可切除的IIIB期, 6例患者(7%)为IIIC期, 79例患者(89%)为IV期。

                研究概况

疗效评估人群中的ORR为51%(包括18例CR,27例PR),DCR为70%(包括18例CR,27例PR和17例SD),中位DoR为33个月;13例既往接受过放疗的患者, 其ORR为64%(包括5例CR)。中位PFS为12.4个月(95% CI 6.4 to 24.9)。56例患者PDL1表达水可评估,其中30例患者(54%)为PDL1阳性。PDL1阳性和阴性患者的ORR分别为70% 和46%;DCR分别为87% 和62%。

                  疗效评估

中位出现疗效应答的时间为2.79个月(2.07,20.68)。取得完全缓解(CR)或部分缓解(PR)的患者有持久的应答,中位DOR为30.4个月(19.1, 32.7)。数据截止时,34例患者仍有应答。53例患者(60%)仍然存活,中位OS仍未达到。

毒性评估在114例患者进行,常见不良事件为疲劳(62.3%),皮疹(40.4%),瘙痒(35.1%),恶心(28.1%),腹泻(22.8%),和关节痛(21.9%)。24例患者 (21%) 因为治疗相关不良事件导致中断治疗,常见原因为皮疹,转氨酶升高或脂肪酶和淀粉酶升高。

           常见不良事件

综上,研究表明IDO抑制剂indoximod联合PD1抑制剂帕博利珠单抗(pembrolizumab)治疗晚期黑色素瘤有疗效且毒性可控,未来值得进一步探索。

原始出处:

Yousef Zakharia, Robert R McWilliams, Olivier Rixe, et al. Phase II trial of the IDO pathway inhibitor indoximod plus pembrolizumab for the treatment of patients with advanced melanoma. J Immunother Cancer. 2021 Jun;9(6):e002057.  doi: 10.1136/jitc-2020-002057.

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encryptionId=9517942978, topicName=IDO抑制剂)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=1ea832038829, createdName=bshuang, createdTime=Sun Aug 29 14:06:19 CST 2021, time=2021-08-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1728977, encodeId=50b61e289777a, content=<a href='/topic/show?id=986913980dd' target=_blank style='color:#2F92EE;'>#PE#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13980, encryptionId=986913980dd, topicName=PE)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f06c33759375, createdName=feather89, createdTime=Wed Aug 04 16:06:19 CST 2021, time=2021-08-04, status=1, ipAttribution=)]
    2021-10-01 snf701207
  4. 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encryptionId=9517942978, topicName=IDO抑制剂)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=1ea832038829, createdName=bshuang, createdTime=Sun Aug 29 14:06:19 CST 2021, time=2021-08-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1728977, encodeId=50b61e289777a, content=<a href='/topic/show?id=986913980dd' target=_blank style='color:#2F92EE;'>#PE#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13980, encryptionId=986913980dd, topicName=PE)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f06c33759375, createdName=feather89, createdTime=Wed Aug 04 16:06:19 CST 2021, time=2021-08-04, status=1, ipAttribution=)]
    2021-09-15 jklm09
  5. 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encryptionId=9517942978, topicName=IDO抑制剂)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=1ea832038829, createdName=bshuang, createdTime=Sun Aug 29 14:06:19 CST 2021, time=2021-08-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1728977, encodeId=50b61e289777a, content=<a href='/topic/show?id=986913980dd' target=_blank style='color:#2F92EE;'>#PE#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13980, encryptionId=986913980dd, topicName=PE)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f06c33759375, createdName=feather89, createdTime=Wed Aug 04 16:06:19 CST 2021, time=2021-08-04, status=1, ipAttribution=)]
    2021-08-18 chendoc242
  6. [GetPortalCommentsPageByObjectIdResponse(id=1721032, encodeId=67541e21032d9, content=<a href='/topic/show?id=634ee040179' target=_blank style='color:#2F92EE;'>#疗效和安全性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=56, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=70401, encryptionId=634ee040179, topicName=疗效和安全性)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=16ef32982072, createdName=经常头晕, createdTime=Tue Sep 28 06:06:19 CST 2021, time=2021-09-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2020113, encodeId=3fd6202011311, content=<a href='/topic/show?id=328713934ea' target=_blank style='color:#2F92EE;'>#PD1抑制剂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=49, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13934, encryptionId=328713934ea, topicName=PD1抑制剂)], attachment=null, authenticateStatus=null, 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encryptionId=9517942978, topicName=IDO抑制剂)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=1ea832038829, createdName=bshuang, createdTime=Sun Aug 29 14:06:19 CST 2021, time=2021-08-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1728977, encodeId=50b61e289777a, content=<a href='/topic/show?id=986913980dd' target=_blank style='color:#2F92EE;'>#PE#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13980, encryptionId=986913980dd, topicName=PE)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f06c33759375, createdName=feather89, createdTime=Wed Aug 04 16:06:19 CST 2021, time=2021-08-04, status=1, ipAttribution=)]
    2021-08-25 sunylz
  7. [GetPortalCommentsPageByObjectIdResponse(id=1721032, encodeId=67541e21032d9, content=<a href='/topic/show?id=634ee040179' target=_blank style='color:#2F92EE;'>#疗效和安全性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=56, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=70401, encryptionId=634ee040179, topicName=疗效和安全性)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=16ef32982072, createdName=经常头晕, createdTime=Tue Sep 28 06:06:19 CST 2021, time=2021-09-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2020113, encodeId=3fd6202011311, content=<a href='/topic/show?id=328713934ea' target=_blank style='color:#2F92EE;'>#PD1抑制剂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=49, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13934, encryptionId=328713934ea, topicName=PD1抑制剂)], attachment=null, authenticateStatus=null, createdAvatar=https://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTIW7uIr5ebYvJohUq0dkkVV05uF9jPpeyCrlcx904mUdMI9UKqpO3bt4GkgYBNdv485qT2NsVE27w/132, createdBy=023c2500122, createdName=ms8543593053280928, createdTime=Fri Apr 08 15:06:19 CST 2022, time=2022-04-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1912623, encodeId=f82e191262368, content=<a href='/topic/show?id=4de7112046c' target=_blank style='color:#2F92EE;'>#mAb#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=59, 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 Oct 01 00:06:19 CST 2021, time=2021-10-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1852681, encodeId=25ed1852681c6, 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=39, 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=Wed Sep 15 05:06:19 CST 2021, time=2021-09-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1787024, encodeId=b15a1e87024ac, content=<a href='/topic/show?id=38601402654' target=_blank style='color:#2F92EE;'>#Pembro#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=58, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=14026, encryptionId=38601402654, topicName=Pembro)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8994206, createdName=chendoc242, createdTime=Wed Aug 18 05:06:19 CST 2021, time=2021-08-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1680733, encodeId=22051680e3396, content=<a href='/topic/show?id=9e5c86e0712' target=_blank style='color:#2F92EE;'>#色素#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, 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=Wed Aug 25 20:06:19 CST 2021, time=2021-08-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2056882, encodeId=9ab52056882c0, content=<a href='/topic/show?id=7ca2484816b' target=_blank style='color:#2F92EE;'>#帕博利珠#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=47, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=48481, encryptionId=7ca2484816b, topicName=帕博利珠)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8ebc122, createdName=yankaienglish, createdTime=Sun Feb 13 19:06:19 CST 2022, time=2022-02-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1703533, encodeId=894a1e035331b, content=<a href='/topic/show?id=327e9425fc' target=_blank style='color:#2F92EE;'>#IDO#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=44, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9425, encryptionId=327e9425fc, topicName=IDO)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=3e3a30514791, createdName=tongyongming, createdTime=Tue Mar 01 08:06:19 CST 2022, time=2022-03-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1715771, encodeId=22e31e157718c, content=<a href='/topic/show?id=9517942978' target=_blank style='color:#2F92EE;'>#IDO抑制剂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=51, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9429, encryptionId=9517942978, topicName=IDO抑制剂)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=1ea832038829, createdName=bshuang, createdTime=Sun Aug 29 14:06:19 CST 2021, time=2021-08-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1728977, encodeId=50b61e289777a, content=<a href='/topic/show?id=986913980dd' target=_blank style='color:#2F92EE;'>#PE#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13980, encryptionId=986913980dd, topicName=PE)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f06c33759375, createdName=feather89, createdTime=Wed Aug 04 16:06:19 CST 2021, time=2021-08-04, status=1, ipAttribution=)]
  8. [GetPortalCommentsPageByObjectIdResponse(id=1721032, encodeId=67541e21032d9, content=<a href='/topic/show?id=634ee040179' target=_blank style='color:#2F92EE;'>#疗效和安全性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=56, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=70401, encryptionId=634ee040179, topicName=疗效和安全性)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=16ef32982072, createdName=经常头晕, createdTime=Tue Sep 28 06:06:19 CST 2021, time=2021-09-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2020113, encodeId=3fd6202011311, content=<a href='/topic/show?id=328713934ea' target=_blank style='color:#2F92EE;'>#PD1抑制剂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=49, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13934, encryptionId=328713934ea, topicName=PD1抑制剂)], attachment=null, authenticateStatus=null, createdAvatar=https://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTIW7uIr5ebYvJohUq0dkkVV05uF9jPpeyCrlcx904mUdMI9UKqpO3bt4GkgYBNdv485qT2NsVE27w/132, createdBy=023c2500122, createdName=ms8543593053280928, createdTime=Fri Apr 08 15:06:19 CST 2022, time=2022-04-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1912623, encodeId=f82e191262368, content=<a href='/topic/show?id=4de7112046c' target=_blank style='color:#2F92EE;'>#mAb#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=59, 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 Oct 01 00:06:19 CST 2021, time=2021-10-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1852681, encodeId=25ed1852681c6, 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=39, 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=Wed Sep 15 05:06:19 CST 2021, time=2021-09-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1787024, encodeId=b15a1e87024ac, content=<a href='/topic/show?id=38601402654' target=_blank style='color:#2F92EE;'>#Pembro#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=58, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=14026, encryptionId=38601402654, topicName=Pembro)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8994206, createdName=chendoc242, createdTime=Wed Aug 18 05:06:19 CST 2021, time=2021-08-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1680733, encodeId=22051680e3396, content=<a href='/topic/show?id=9e5c86e0712' target=_blank style='color:#2F92EE;'>#色素#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, 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=Wed Aug 25 20:06:19 CST 2021, time=2021-08-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2056882, encodeId=9ab52056882c0, content=<a href='/topic/show?id=7ca2484816b' target=_blank style='color:#2F92EE;'>#帕博利珠#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=47, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=48481, encryptionId=7ca2484816b, topicName=帕博利珠)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8ebc122, createdName=yankaienglish, createdTime=Sun Feb 13 19:06:19 CST 2022, time=2022-02-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1703533, encodeId=894a1e035331b, content=<a href='/topic/show?id=327e9425fc' target=_blank style='color:#2F92EE;'>#IDO#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=44, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9425, encryptionId=327e9425fc, topicName=IDO)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=3e3a30514791, createdName=tongyongming, createdTime=Tue Mar 01 08:06:19 CST 2022, time=2022-03-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1715771, encodeId=22e31e157718c, content=<a href='/topic/show?id=9517942978' target=_blank style='color:#2F92EE;'>#IDO抑制剂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=51, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9429, encryptionId=9517942978, topicName=IDO抑制剂)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=1ea832038829, createdName=bshuang, createdTime=Sun Aug 29 14:06:19 CST 2021, time=2021-08-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1728977, encodeId=50b61e289777a, content=<a href='/topic/show?id=986913980dd' target=_blank style='color:#2F92EE;'>#PE#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13980, encryptionId=986913980dd, topicName=PE)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f06c33759375, createdName=feather89, createdTime=Wed Aug 04 16:06:19 CST 2021, time=2021-08-04, status=1, ipAttribution=)]
    2022-03-01 tongyongming
  9. [GetPortalCommentsPageByObjectIdResponse(id=1721032, encodeId=67541e21032d9, content=<a href='/topic/show?id=634ee040179' target=_blank style='color:#2F92EE;'>#疗效和安全性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=56, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=70401, encryptionId=634ee040179, topicName=疗效和安全性)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=16ef32982072, createdName=经常头晕, createdTime=Tue Sep 28 06:06:19 CST 2021, time=2021-09-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2020113, encodeId=3fd6202011311, content=<a href='/topic/show?id=328713934ea' target=_blank style='color:#2F92EE;'>#PD1抑制剂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=49, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13934, encryptionId=328713934ea, topicName=PD1抑制剂)], attachment=null, authenticateStatus=null, 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  10. 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