重磅: 厉害了!FDA批准Kymriah用于复发/难治大B细胞淋巴瘤治疗

2018-05-02 虚怀若谷 肿瘤资讯

弥漫大B细胞淋巴瘤(DLBCL)是最为常见的非霍奇金淋巴瘤(NHL)亚型,其标准治疗方案为R-CHOP,疗效尚可,但复发/难治DLBCL仍存在较大的治疗挑战,而嵌合抗原受体T细胞免疫治疗(CAR-)则为其提供了新的治疗方向。近来,诺华公司研发的Kymriah在R/R-DLBCL治疗领域取得了重大突破。

弥漫大B细胞淋巴瘤(DLBCL)是最为常见的非霍奇金淋巴瘤(NHL)亚型,其标准治疗方案为R-CHOP,疗效尚可,但复发/难治DLBCL仍存在较大的治疗挑战,而嵌合抗原受体T细胞免疫治疗(CAR-)则为其提供了新的治疗方向。近来,诺华公司研发的Kymriah在R/R-DLBCL治疗领域取得了重大突破。

重磅NEWS

2018年5月2日,诺华公司传来重磅喜讯!美国FDA将Kymriah(CTL019)的适应症扩大至复发/难治性大B细胞淋巴瘤患者,包括弥漫大B细胞淋巴瘤(DLBCL)、继发于滤泡淋巴瘤(FL)的DLBCL患者及高级别B细胞淋巴瘤。

值得指出的是,这已经是Kymriah(CTL019)的第二个适应症。Kymriah是诺华公司与宾夕法尼亚大学联合研发、全球首个由FDA批准用于临床治疗的CAR-T产品,主要治疗靶点为CD19,在血液恶性肿瘤的治疗中具有举足轻重的地位。2017年8月,CAR-T治疗迎来历史性时刻,美国FDA批准首个CAR-T产品Kymriah用于25岁以下B细胞前体急性淋巴细胞白血病(ALL)患者的治疗。

对于Kymriah治疗适应症的再次扩大,宾夕法尼亚大学及Abramson癌症中心的Schuster教授说道:“Kymriah的治疗目标主要为使复发/难治DLBCL(R/R-DLBCL)患者达到持久的缓解状态。随着FDA批准Kymriah用于R/R-DLBCL的治疗,血液科医生又拥有了一项治疗R/R-DLBCL的新利器,这有望使R/R-DLBCL患者在不进行骨髓移植的情况下达到持续缓解和长期生存。”

JULIET研究:Kymriah适应症扩大的最关键依据,疗效数据再次更新

FDA将Kymriah的临床适应症扩大为复发/难治大B细胞淋巴瘤,主要基于JULIET研究的良好结果。JULIET研究是一项全球多中心、II期临床试验,在2017年ASH会议上便大放异彩,当时JULIET研究更新的结果显示,Kymriah对于R/R-DLBCL患者的总体有效率(ORR)达53%,完全缓解率(CR)达40%。

目前,JULIET研究数据再次更新,在Kymriah的有效性分析中,共有68例复发/难治弥漫大B细胞淋巴瘤(R/R-DLBCL)患者可获取数据,均采用Kymriah进行单药治疗。结果显示,R/R-DLBCL患者的总体有效率(ORR)达50%,其中完全缓解率(CR)达32%,部分缓解率(PR)达18%,中位缓解持续时间(DOR)仍未达到。由此可见,Kymriah在R/R-DLBCL的治疗中具有显着的疗效。

在安全性方面,共纳入106例R/R-DLBCL患者进行分析,不良事件(AEs)总体发生率为20%左右,其中最常见的3-4级AEs为血小板减少(40%)、感染(25%)、细胞因子释放综合症(23%)、神经毒性(18%)及恶心乏力等。总体上,Kymriah的安全性尚可,AEs多为可控性。

小结

Kymriah适应症扩大至复发/难治大B细胞淋巴瘤具有极其重大的临床意义,根据研究显示,Kymriah对于复发难治DLBCL患者具有极为良好的疗效,且安全性可靠。这使得R/R-DLBCL患者在不接受自体干细胞移植(ASCT)或ASCT失败的情况下,能可获得高缓解率、维持长期的缓解状态。

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    2019-01-08 bugit
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    2018-06-13 Jenny3912

    涨知识了

    0

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    2018-09-01 grace5700
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    2018-05-12 大爰

    学习了谢谢分享!!

    0

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    2018-05-04 xxxx1054
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    2018-05-03 大爰

    学习了谢谢分享!!

    0

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    2018-05-02 王秀

    学习了.涨知识了!

    0

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