AACR 2020:靶向联合免疫治疗显著延长BRAF突变晚期黑色素瘤患者无进展生存(IMspire150试验)

2020-05-01 MedSci MedSci原创

2020年AACR年会采用线上虚拟会议的形式召开。4月27日美国东部时间上午临床全体大会环节,来自澳大利亚彼得·麦克卡勒姆癌症中心的Grant McArthur教授报告了IMspire1

2020年AACR年会采用线上虚拟会议的形式召开。4月27日美国东部时间上午临床全体大会环节,来自澳大利亚彼得·麦克卡勒姆癌症中心的Grant McArthur教授报告了IMspire150试验的结果。该项研究是全球首个成功的靶向治疗联合免疫治疗用于晚期黑色素瘤的Ⅲ期试验。2019年12 月 13 日,罗氏集团宣布正在进行的 III 期 IMspire150 研究达到了其无进展生存期 (PFS) 的主要终点,该研究针对先前未经治疗的 BRAF V600 突变阳性的晚期黑色素瘤患者。研究表明,与安慰剂加 Cobimetinib (Cotellic) 和维莫非尼相比,阿替利珠单抗 (Tecentriq) 联合维莫非尼 (Zelboraf,佐博伏) 和 Cobimetinib 有助于减少疾病恶化或死亡的危险。

IMspire150试验是一项Ⅲ期、随机、双盲、安慰剂对照研究,在BRAFV600 突变的无法手术切除的ⅢC或Ⅳ 期(AJCC 第 7 版)、存在可测量病灶(根据RESIST 1.1)的黑色素瘤患者中进行。研究比较了抗 PD-L1 抗体阿替利珠单抗(A)联合BRAF抑制剂维莫非尼(V)和MEK抑制剂Cobimetinib (C)对比维莫非尼(V)联合Cobimetinib (C)在既往未经治疗的BRAF V600突变晚期黑色素瘤患者中的疗效和安全性。

主要终点为研究者评估的无进展生存期 (PFS)。次要终点包括IRC 评估的 PFS,总缓解率(ORR),缓解持续时间(DOR),总生存期(OS)和安全性。

不同于其他联合治疗试验的设计,IMspire 150试验在治疗初始阶段设计了为期28天的靶向治疗导入期,从第二个28天周期开始加入阿替利珠单抗(A)开始联合治疗;而先前所有联合治疗试验均设计为所有药物同时开始治疗。该设计基于早期基础研究发现,靶向治疗开始后免疫微环境会出现一系列有利于免疫治疗的变化。

试验共入组了 514 例患者 (V+C+A=256;V+C+安慰剂=258),中位随访时间为 18.9 个月。V+C+A 与 V+C+安慰剂相比,研究者评估的PFS相比对照组的中位10.6个月,显著提升至15.1 个月;降低疾病进展风险22%(HR=0.78;95%CI,0.63至0.97;  P=0.025),所有亚组中观察到的获益一致。

虽然V+C+A与 V+C+安慰剂两组的客观缓解率相似(66.3% vs 65%),但V+C+A联合治疗组的中位缓解持续时间(DOR)达到21.0个月,长于对照组的12.6个月。本次公布的中期结果分析,总生存期尚未成熟仍需更长时间随访,但目前总生存获益倾向V+C+A联合治疗组。

V+C+A联合治疗组的治疗相关严重不良事件发生率与V+C+安慰剂组相似(33.5%与28.8%)。V+C+A联合治疗组与V+C+安慰剂组分别有12.6% 和 15.7% 的患者因不良事件停止所有治疗。联合治疗方案的安全性特征总体上与单个药物的已知特征一致。

维莫非尼是一种BRAF抑制剂,也是全球首个用于治疗BRAF突变阳性的无法手术切除或者转移性黑色素瘤的靶向治疗。维莫非尼已于2017年在中国获批上市,并于2018年被纳入《国家基本医疗保险、工伤保险和生育保险药品目录》。

阿替利珠单抗是一种PD-L1单抗,有潜力作为肿瘤免疫治疗的基础性用药,已于2020年2月在中国获批广泛期小细胞肺癌一线治疗适应证,并在全球多个国家获批用于治疗非小细胞和小细胞肺癌,某些类型的转移性尿路上皮癌和PD-L1阳性转移性三阴性乳腺癌。

Cobimetinib 是一种 MEK1/2(一种有助于控制细胞生⻓和存活的细胞信号传导途径中的蛋白质) 抑制剂,已在美国和欧洲以及世界许多国家/地区批准与维莫非尼联合用药,用于治疗无法手术切除或转移性的 BRAF V600 突变的黑色素瘤患者。

IMspire150试验,是首个成功的靶向治疗联合免疫治疗用于晚期黑色素瘤的Ⅲ期试验。该研究的成功为靶向治疗与免疫治疗的治疗策略优化提供了新的证据,为晚期黑色素瘤指明了未来研究的方向,有望改写指南成为BRAF突变晚期黑色素瘤新的一线治疗选择。

首席医学官兼全球产品开发部主管 Levi Garraway 博士说:通过将癌症免疫疗法与靶向疗法相结合,我们希望提供一种新的方法,以改善晚期 BRAF 突变型黑色素瘤患者的预后。

原始出处

Grant A. McArthur,et al. Evaluation of atezolizumab (A), cobimetinib (C), and vemurafenib (V) in previously untreated patients with BRAFV600 mutation-positive advanced melanoma: Primary results from the phase 3 IMspire150 trial. AACR 2020 Session VCTPL01 - Opening Clinical Plenary CT012

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    2021-01-20 sunylz
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    2020-07-08 tamgche
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beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=3671, encryptionId=e76836e150, topicName=BRAF突变)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=eff97667327, createdName=ms4964546379600229, createdTime=Sun May 03 08:34:54 CST 2020, time=2020-05-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1552021, encodeId=9e6215520217b, content=<a href='/topic/show?id=169c166430' target=_blank style='color:#2F92EE;'>#AACR#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=42, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1664, encryptionId=169c166430, topicName=AACR)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=6b2714248200, createdName=Luyuxie_14, createdTime=Sun May 03 08:34:54 CST 2020, time=2020-05-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1559006, encodeId=9fac15590062e, content=<a href='/topic/show?id=e27610332666' target=_blank style='color:#2F92EE;'>#黑色素#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=19, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=103326, encryptionId=e27610332666, topicName=黑色素)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=150614999302, createdName=cqlidoudou, createdTime=Sun May 03 08:34:54 CST 2020, time=2020-05-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1565015, encodeId=e12515650156a, content=<a href='/topic/show?id=e27610332666' target=_blank style='color:#2F92EE;'>#黑色素#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=103326, encryptionId=e27610332666, topicName=黑色素)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=150614999302, createdName=cqlidoudou, createdTime=Sun May 03 08:34:54 CST 2020, time=2020-05-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1598483, encodeId=23bf159848392, content=<a href='/topic/show?id=32f636e2a8' target=_blank style='color:#2F92EE;'>#BRAF突变晚期黑色素瘤#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=3672, encryptionId=32f636e2a8, topicName=BRAF突变晚期黑色素瘤)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=569918610703, createdName=jiadan198788, createdTime=Sun May 03 08:34:54 CST 2020, time=2020-05-03, status=1, ipAttribution=)]
  4. [GetPortalCommentsPageByObjectIdResponse(id=1680666, encodeId=a91516806665e, content=<a href='/topic/show?id=9e5c86e0712' target=_blank style='color:#2F92EE;'>#色素#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, 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 Jan 20 10:34:54 CST 2021, time=2021-01-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1853138, encodeId=e2561853138c1, content=<a href='/topic/show?id=f1b41665ac' target=_blank style='color:#2F92EE;'>#AACR 2020#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1665, encryptionId=f1b41665ac, topicName=AACR 2020)], attachment=null, authenticateStatus=null, 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beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=3671, encryptionId=e76836e150, topicName=BRAF突变)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=eff97667327, createdName=ms4964546379600229, createdTime=Sun May 03 08:34:54 CST 2020, time=2020-05-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1552021, encodeId=9e6215520217b, content=<a href='/topic/show?id=169c166430' target=_blank style='color:#2F92EE;'>#AACR#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=42, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1664, encryptionId=169c166430, topicName=AACR)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=6b2714248200, createdName=Luyuxie_14, createdTime=Sun May 03 08:34:54 CST 2020, time=2020-05-03, status=1, ipAttribution=), 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createdBy=150614999302, createdName=cqlidoudou, createdTime=Sun May 03 08:34:54 CST 2020, time=2020-05-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1598483, encodeId=23bf159848392, content=<a href='/topic/show?id=32f636e2a8' target=_blank style='color:#2F92EE;'>#BRAF突变晚期黑色素瘤#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=3672, encryptionId=32f636e2a8, topicName=BRAF突变晚期黑色素瘤)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=569918610703, createdName=jiadan198788, createdTime=Sun May 03 08:34:54 CST 2020, time=2020-05-03, status=1, ipAttribution=)]
    2020-05-03 zhaojie88
  5. [GetPortalCommentsPageByObjectIdResponse(id=1680666, encodeId=a91516806665e, content=<a href='/topic/show?id=9e5c86e0712' target=_blank style='color:#2F92EE;'>#色素#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, 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 Jan 20 10:34:54 CST 2021, time=2021-01-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1853138, encodeId=e2561853138c1, content=<a href='/topic/show?id=f1b41665ac' target=_blank style='color:#2F92EE;'>#AACR 2020#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1665, encryptionId=f1b41665ac, topicName=AACR 2020)], attachment=null, authenticateStatus=null, 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createdBy=150614999302, createdName=cqlidoudou, createdTime=Sun May 03 08:34:54 CST 2020, time=2020-05-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1598483, encodeId=23bf159848392, content=<a href='/topic/show?id=32f636e2a8' target=_blank style='color:#2F92EE;'>#BRAF突变晚期黑色素瘤#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=3672, encryptionId=32f636e2a8, topicName=BRAF突变晚期黑色素瘤)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=569918610703, createdName=jiadan198788, createdTime=Sun May 03 08:34:54 CST 2020, time=2020-05-03, status=1, ipAttribution=)]
    2020-05-03 10518094zz
  6. 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  7. [GetPortalCommentsPageByObjectIdResponse(id=1680666, encodeId=a91516806665e, content=<a href='/topic/show?id=9e5c86e0712' target=_blank style='color:#2F92EE;'>#色素#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, 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 Jan 20 10:34:54 CST 2021, time=2021-01-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1853138, encodeId=e2561853138c1, content=<a href='/topic/show?id=f1b41665ac' target=_blank style='color:#2F92EE;'>#AACR 2020#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1665, encryptionId=f1b41665ac, topicName=AACR 2020)], attachment=null, authenticateStatus=null, 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beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=3671, encryptionId=e76836e150, topicName=BRAF突变)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=eff97667327, createdName=ms4964546379600229, createdTime=Sun May 03 08:34:54 CST 2020, time=2020-05-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1552021, encodeId=9e6215520217b, content=<a href='/topic/show?id=169c166430' target=_blank style='color:#2F92EE;'>#AACR#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=42, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1664, encryptionId=169c166430, topicName=AACR)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=6b2714248200, createdName=Luyuxie_14, createdTime=Sun May 03 08:34:54 CST 2020, time=2020-05-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1559006, encodeId=9fac15590062e, content=<a href='/topic/show?id=e27610332666' target=_blank style='color:#2F92EE;'>#黑色素#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=19, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=103326, encryptionId=e27610332666, topicName=黑色素)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=150614999302, createdName=cqlidoudou, createdTime=Sun May 03 08:34:54 CST 2020, time=2020-05-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1565015, encodeId=e12515650156a, content=<a href='/topic/show?id=e27610332666' target=_blank style='color:#2F92EE;'>#黑色素#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=103326, encryptionId=e27610332666, topicName=黑色素)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=150614999302, createdName=cqlidoudou, createdTime=Sun May 03 08:34:54 CST 2020, time=2020-05-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1598483, encodeId=23bf159848392, content=<a href='/topic/show?id=32f636e2a8' target=_blank style='color:#2F92EE;'>#BRAF突变晚期黑色素瘤#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=3672, encryptionId=32f636e2a8, topicName=BRAF突变晚期黑色素瘤)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=569918610703, createdName=jiadan198788, createdTime=Sun May 03 08:34:54 CST 2020, time=2020-05-03, status=1, ipAttribution=)]
    2020-05-03 Luyuxie_14
  8. [GetPortalCommentsPageByObjectIdResponse(id=1680666, encodeId=a91516806665e, content=<a href='/topic/show?id=9e5c86e0712' target=_blank style='color:#2F92EE;'>#色素#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, 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 Jan 20 10:34:54 CST 2021, time=2021-01-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1853138, encodeId=e2561853138c1, content=<a href='/topic/show?id=f1b41665ac' target=_blank style='color:#2F92EE;'>#AACR 2020#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1665, encryptionId=f1b41665ac, topicName=AACR 2020)], attachment=null, authenticateStatus=null, 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createdBy=150614999302, createdName=cqlidoudou, createdTime=Sun May 03 08:34:54 CST 2020, time=2020-05-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1598483, encodeId=23bf159848392, content=<a href='/topic/show?id=32f636e2a8' target=_blank style='color:#2F92EE;'>#BRAF突变晚期黑色素瘤#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=3672, encryptionId=32f636e2a8, topicName=BRAF突变晚期黑色素瘤)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=569918610703, createdName=jiadan198788, createdTime=Sun May 03 08:34:54 CST 2020, time=2020-05-03, status=1, ipAttribution=)]
  9. 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  10. [GetPortalCommentsPageByObjectIdResponse(id=1680666, encodeId=a91516806665e, content=<a href='/topic/show?id=9e5c86e0712' target=_blank style='color:#2F92EE;'>#色素#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, 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 Jan 20 10:34:54 CST 2021, time=2021-01-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1853138, encodeId=e2561853138c1, content=<a href='/topic/show?id=f1b41665ac' target=_blank style='color:#2F92EE;'>#AACR 2020#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1665, encryptionId=f1b41665ac, topicName=AACR 2020)], attachment=null, authenticateStatus=null, 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