CAR-T细胞疗法在美国血液学会ASH上大放异彩

2019-12-16 不详 MedSci原创

百事美施贵宝(BMS)和强生(Janssen)开发的嵌合抗原受体T细胞疗法(CAR-T)在中期试验中均达到了终点,为治疗难治性血液癌带来了希望。

百事美施贵宝(BMS)和强生(Janssen)开发的嵌合抗原受体T细胞疗法(CAR-T)在中期试验中均达到了终点,为治疗难治性血液癌带来了希望。

强生公司公布了Ib / II期CARTITUDE-1研究的初步结果,该研究评估了针对B细胞成熟抗原(BCMA)的CAR-T 疗法JNJ-68284528(JNJ-4528),在治疗复发或难治性多发性骨髓瘤中的功效和安全性。

该研究招募了先前至少接受过三次治疗、对蛋白酶体抑制剂(PI)和免疫调节药物(IMiD)有双重耐药性的患者、先前已接受过PI、IMiD和抗CD38抗体治疗、以及在最后一疗程的12个月内进展的患者。

CARTITUDE-1研究的Ib期部分结果显示, 69%接受JNJ-4528治疗的患者达到完全缓解(CR),86%的患者达到了很好的局部反应(VGPR),14%的患者达到部分缓解(PR)。

在输注后第28天,可评估患者中有100%达到了早期最小残留病(MRD)阴性的状态,而在六个月的随访中,29例患者中有27例无进展。

根据数据,美国监管机构已在美国授予JNJ-4528突破性称号。

Liso-cel也已达到终点

百时美施贵宝(Bristol-Myers Squibb)的CAR-T细胞疗法liso-cel(lisocabtagene maraleucel)在血液癌患者的两项试验中显示出希望。

这些研究包括对复发或难治的慢性淋巴细胞性白血病(CLL)或小淋巴细胞性淋巴瘤(SLL)患者进行Liso-cel评估。一项针对不适合大剂量化疗和造血干细胞移植(HSCT)、复发或难治性大B细胞非霍奇金淋巴瘤(NHL)二线患者的研究。

II期PILOT研究在复发/难治性大B细胞NHL患者中进行评估,这些患者先前仅接受过一种免疫化学疗法,由于年龄、合并症或工作状态等因素而被认为不适合HSCT。

所有符合评估条件的患者均获得缓解,其中六位患者(50%)获得了CR,12例患者中有7例(58%)在liso-cel输注后三个月维持了缓解水平。

在这13例患者中,有61.5%的患者至少有一种与治疗相关的3级或更高的副作用,主要是血细胞减少症。4名患者的3级或更高血细胞减少症时间延长。

I / II TRANSCEND CLL 004期研究为先前接受过中位数为5种手段治疗的患者。所有患者(23/23)都曾接受过依鲁替尼治疗,大多数(21/23)患者对BTK抑制剂耐药或已复发。有9例(39%)的BTK抑制剂和Venetoclax均失败,大多数(83%)被认为具有高风险特征。

中位随访11个月接受lisocel的患者的总缓解率(ORR)为81.5%,其中45.5%的患者获得了完全缓解(CR)。在未使用BTK抑制剂和Venetoclax失败的患者中,ORR为89%,其中67例达到CR。

两家公司指出,在可评估为最小残留疾病(MRD)的20例患者中,大多数患者通过下一代测序在血液(75%)和骨髓(65%)中检测不到MRD。

在安全方面,所有患者均发生任何级别的治疗紧急不良事件(TEAE),其中96%的患者发生3级或更高的副作用,包括贫血(78%),血小板减少症(70%),中性粒细胞减少症(56.5%),白细胞减少症(43.5%),发热性中性粒细胞减少症(26%),淋巴细胞减少症(26%)和细胞因子释放综合症(9%)。

而且,74%的患者患有细胞因子释放综合征(CRS),其中9%的患者经历3级CRS。39%的人患有神经系统事件,而22%的人具有3级或更高级别的神经系统事件。

BMS细胞疗法开发高级副总裁Stanley Frankel说:"随着我们继续在重要的新疾病背景和未满足的医疗需求领域评估liso-cel,我们很高兴看到这些研究的早期结果。"

所有研究的数据都在佛罗里达州奥兰多市的美国血液学会(ASH)年度会议上发表。

原始出处:


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    2020-11-11 仁者大医
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    2019-12-18 kksonne
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