CAR-T对手来了!CD19单抗tafasitamab联合来那度胺治疗淋巴瘤提交FDA上市申请

2020-05-06 MedSci MedSci原创

德国生物制药公司MorphoSys近日发布了新型人源化Fc结构域优化免疫增强单克隆抗体tafasitamab(MOR208)II期临床研究L-MIND(NCT02399085)的最终分析结果。今年1月

德国生物制药公司MorphoSys近日发布了新型人源化Fc结构域优化免疫增强单克隆抗体tafasitamab(MOR208)II期临床研究L-MIND(NCT02399085)的最终分析结果。今年1月,MorphoSys与Incyte签订一项价值20亿美元的全球合作及许可协议,进一步开发和商业化tafasitamab。根据协议,Incyte将支付一笔7.5亿美元预付款,并向MorphoSys投资1.5亿美元购买其美国存托股票。根据特定的开发、监管、商业化里程碑的实现情况,MorphoSys还将有资格获得高达11亿美元的里程碑付款。

2019年12月30日,已向美国食品和药物管理局(FDA)提交了tafasitamab(MOR208)的生物制品许可申请(BLA),联合来那度胺治疗复发或难治性弥漫性大B细胞淋巴瘤(r/r DLBCL)患者。tafasitamab是一种靶向CD19的新型人源化Fc结构域优化免疫增强单克隆抗体,CD19是多种B细胞恶性肿瘤的一个明确生物标志物。

2020年3月3日,美国FDA已接受其开发的tafasitamab与 来那度胺(lenalidomide)联用,治疗复发/难治性弥漫性大B细胞淋巴瘤(DLBCL)患者的生物制品许可申请(BLA),并同时授予其优先审评资格,预计将于今年8月30日前做出回复。

L-MIND是一项单臂、开放标签、多中心研究,评估tafasitamab联合来那度胺(lenalidomide)治疗复发性/难治性弥漫性大B细胞淋巴瘤(R/R DLBCL)成人患者的疗效和安全性,这些患者既往已接受至少一种但不超过3种系统治疗方案,并且不符合高剂量化疗(HDC)和自体干细胞移植(ASCT)条件。

此次数据包括了80例入组研究的患者,这些患者接受了tafasitamab与来那度胺联合治疗,并按照研究方案至少随访了一年。更新的疗效结果基于独立审查委员会对所有患者评估的缓解。

结果显示,研究达到了总缓解率(ORR)主要终点:联合治疗组的ORR为60%(n=48/80)、完全缓解率为43%(n=34/80)。随访17.3个月,中位无进展生存期为12.1个月,中位缓解持续时间为21.7个月。详细数据将在今年6月在瑞士卢加诺举行的恶性淋巴瘤国际会议(ICML)上公布。这些数据确认了2018年12月在美国血液学会(ASH)年会上发布的数据:中位随访8.3个月,总缓解率为49%、完全缓解率为31%。

L-MIND研究首席研究员、法国里昂大学临床血液学系主任Gilles Salles教授评价称,“特别高兴能看到如此高的完全缓解率和缓解持续时间数据,这在R/R DLBCL群体中并不常见。如果批准,基于良好的安全性,tafasitamab联合来那度胺将为这类患者提供一种新的治疗方案,改善预后及生活质量。”

Re-MIND研究:是一项针对现实世界数据的观察性、回顾性研究,旨在分离tafasitamab在与来那度胺联合用药方案中的贡献,并证明联合治疗的效果。研究比较了r/r DLBCL患者接受来那度胺单药治疗的真实世界应答数据和在L-MIND研究中tafasitamab与来那度胺联合治疗r/r DLBCL患者疗效结果。该研究收集了美国和欧洲现实世界中接受来那度胺单药治疗的490例不符合移植资格的R/R DLBCL患者数据,其中76例与L-MIND研究中76例患者在重要基线特征方面具有1:1的匹配。

分析显示,研究达到了主要终点:与来那度胺单药治疗相比,tafasitamab+来那度胺组合疗法具有临床优势。具体数据为:与来那度胺单药治疗相比,tafasitamab+来那度胺组合疗法在主要终点ORR方面具有统计学上的显著优越性(ORR:67.1% vs 34.2%,p<0.0001),在所有次要终点方面也观察到一致的优越性,包括:完全缓解率(CR:39.5% vs 11.8%,p<0.0001)、总生存期(中位OS:未达到 vs 9.3个月,p<0.0008)。

“CAR-T杀手”!将向已上市两款CAR-T疗法发起挑战

CD19是一种非常重要的B细胞生物标志物,在B细胞上广泛表达,可增强B细胞受体(BCR)信号传导,这对B细胞存活非常重要。因此,CD19是治疗多种B细胞恶性肿瘤的一个理想靶点。根据美国癌症研究所网站数据,2018年,CD19已超越PD-1成为最热门的免疫肿瘤学靶点,同时也是最热门的细胞疗法靶点。

Tafasitamab是一种靶向CD19的人源化Fc增强单克隆抗体,其Fc结构域进行了修饰(包含2个氨基酸取代S239D和I332E),通过提高对效应细胞上激活型FcγRIIIa的亲和力,显著增强抗体依赖性细胞介导的细胞毒性(ADCC)和抗体依赖性细胞吞噬(ADCP),从而改善肿瘤细胞杀伤的关键机制。临床前模型研究中,tafasitamab已被证实通过结合CD19可诱导癌细胞直接凋亡。

监管方面,tafasitama已被FDA授予治疗R/R DLBCL快速通道资格和突破性药物资格、并被EMA授予治疗DLBCL和CLL/SLL孤儿药资格。

CD19在B细胞各发育阶段的表达及tafasitamab的作用机制

当前,MorphoSys正在开展多项组合疗法研究,评估tafasitamab治疗多种B细胞恶性肿瘤的潜力。关键II/III期研究B-MIND正在评估tafasitamab联合化疗药物苯达莫司汀治疗不符合HDC和ASCT资格的R/R DLBCL患者。II期研究COSMOS正在评估tafasitamab联合idelalisib或venetoclax治疗既往已接受BTK抑制剂(如ibrutinib)治疗的R/R CLL/SLL患者。

根据此次报告的L-MIND研究最终分析数据,MorphoSys计划在今年底前完成向FDA提交tafasitamab联合来那度胺治疗R/R DLBCL的生物制品许可申请(BLA),目前正在积极部署美国市场的营销队伍,为tafasitamab商业化做准备。

Tafasitamab上市后将直接挑战市面上治疗R/R DLBCL的两款CAR-T疗法——诺华Kymriah和吉利德Yescarta。

疗效方面,tafasitamab(ORR=60%,CR=43%)与Kymriah(ORR=50%,CR=32%)和Yescarta(ORR=72%,CR=51%)具有可比性。用药方面,Kymriah和Yescarta均需针对每例患者单独制备,需要耗费一定时间,tafasitamab则是一种工业化生产的即用型单抗,随取随用。治疗成本方面,Kymriah和Yescarta均定价数十万美元,而tafasitamab可以控制的非常低。

也难怪有分析师将tafasitamab称为“CAR-T杀手”,该药上市后势必会对Kymriah和Yescarta带来巨大冲击。

Tafasitamab是一种靶向CD19抗原的人源化单克隆抗体。CD19是在B细胞癌症中广泛表达的抗原,它能够增强B细胞受体介导的信号通路,支持B细胞生存,是靶向B细胞癌症的重要靶点。

目前,tafasitamab正被开发用于2种B细胞恶性肿瘤,包括DLBCL和慢性淋巴细胞白血病(CLL)。在全球范围内,DLBCL是成人中最常见类型的非霍奇金淋巴瘤(NHL),占所有病例的40%;CLL则是成人中最常见的白血病类型。监管方面,FDA在2017年10月授予了tafasitama突破性药物资格(BTD),联合来那度胺治疗不适合大剂量化疗(HDC)和自体干细胞移植(ASCT)的r/r DLBCL患者。2014年,FDA授予tafasitamab治疗r/r DLBCL的快速通道资格(FTD)。同样在2014年,FDA和EMA授予tafasitamab治疗DLBCL和CLL/SLL(小细胞淋巴瘤)的孤儿药资格。

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    2021-02-06 zhanglin3079
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    2021-03-25 gracezdd
  3. [GetPortalCommentsPageByObjectIdResponse(id=1910544, encodeId=6dc51910544ec, content=<a href='/topic/show?id=faf7163606a' target=_blank style='color:#2F92EE;'>#SIT#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=42, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=16360, encryptionId=faf7163606a, topicName=SIT)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e6a1280, createdName=zhanglin3079, createdTime=Sat Feb 06 20:13:14 CST 2021, time=2021-02-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2057988, encodeId=e336205e9888a, content=<a href='/topic/show?id=3836e24819' target=_blank style='color:#2F92EE;'>#FAS#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=53, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7248, encryptionId=3836e24819, topicName=FAS)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=872f168, createdName=gracezdd, createdTime=Thu Mar 25 03:13:14 CST 2021, time=2021-03-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1912351, encodeId=4b7d1912351b8, content=<a href='/topic/show?id=4de7112046c' target=_blank style='color:#2F92EE;'>#mAb#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11204, encryptionId=4de7112046c, topicName=mAb)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=25e7304, createdName=snf701207, createdTime=Wed Oct 28 18:13:14 CST 2020, time=2020-10-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2058250, encodeId=fb5c205825081, content=<a href='/topic/show?id=2f4a1e08342' target=_blank style='color:#2F92EE;'>#tafasitamab#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17083, encryptionId=2f4a1e08342, topicName=tafasitamab)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=fd34186, createdName=wshxjq, createdTime=Thu Jan 14 17:13:14 CST 2021, time=2021-01-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1781358, encodeId=af0d1e81358cc, content=<a href='/topic/show?id=8ce8405907' target=_blank style='color:#2F92EE;'>#CAR-#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4059, encryptionId=8ce8405907, topicName=CAR-)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8e886, createdName=仁者大医, createdTime=Thu Dec 31 15:13:14 CST 2020, time=2020-12-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1958306, encodeId=79041958306fb, content=<a href='/topic/show?id=8cab2865e4' target=_blank style='color:#2F92EE;'>#ASIT#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2865, encryptionId=8cab2865e4, topicName=ASIT)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=148754, createdName=gaoxiaoe, createdTime=Thu May 14 08:13:14 CST 2020, time=2020-05-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1416459, encodeId=ecf5141645948, content=<a href='/topic/show?id=924442e98f' target=_blank style='color:#2F92EE;'>#CD19#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4279, encryptionId=924442e98f, topicName=CD19)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f1583186918, createdName=dingxiaobo, createdTime=Fri May 08 02:13:14 CST 2020, time=2020-05-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1506225, encodeId=d8691506225cf, content=<a href='/topic/show?id=027742832b' target=_blank style='color:#2F92EE;'>#CD19单抗tafasitamab#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=22, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4283, encryptionId=027742832b, topicName=CD19单抗tafasitamab)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=395f25, createdName=爆笑小医, createdTime=Fri May 08 02:13:14 CST 2020, time=2020-05-08, status=1, ipAttribution=)]
    2020-10-28 snf701207
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    2020-12-31 仁者大医
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    2020-05-14 gaoxiaoe
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    2020-05-08 dingxiaobo
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