聚焦阿扎胞苷联合治疗骨髓增生异常综合征的重磅进展

2019-12-07 佚名 肿瘤资讯

骨髓增生异常综合征(MDS)是一组起源于造血干细胞的异质性髓系克隆性疾病,好发于老年患者,临床表现和预后异质性很大。尽管目前对MDS发病机制研究逐步深入,血液病系统领域新药频出,但MDS总体治疗疗效和预后差强人意。

骨髓增生异常综合征(MDS)是一组起源于造血干细胞的异质性髓系克隆性疾病,好发于老年患者,临床表现和预后异质性很大。尽管目前对MDS发病机制研究逐步深入,血液病系统领域新药频出,但MDS总体治疗疗效和预后差强人意。阿扎胞苷是一种去甲基化药物,多研究证实了其在MDS治疗中的显着疗效及可靠安全性。第61届美国血液学会(ASH)年会将于2019年12月7-10日在美国奥兰多隆重举行。在追踪报道本次ASH热点研究的同时,特别关注了阿扎胞苷联合治疗MDS方面的进展。本文对部分最新研究成果进行了梳理,详情如下。

IDH1抑制剂olutasidenib(FT-2102)单药或与阿扎胞苷联合治疗伴IDH1突变的MDS可获得深度缓解

研究共入组20例伴IDH1突变的MDS患者,其中olutasidenib单药组(SA)6例,olutasidenib联合阿扎胞苷组(COMBO)14例;新诊断患者7例,复发/难治性MDS患者13例。结果显示,olutasidenib联合阿扎胞苷治疗安全耐受性良好。中位治疗8个月后,两组患者总的ORR为59%,SA组和COMBO组的ORR分别为33%和73%,两组的CR率分别为17%和55%。

阿扎胞苷联合Venetoclax治疗未治疗的较高危MDS

研究共入组59例患者,15例患者IPSS 1.5分,29例患者IPSS 2分,8例患者IPSS 2.5分,6例患者IPSS 3分,1例患者IPSS 3.5分;细胞遗传学中危和高危的比例分别为19%和24%。结果显示,阿扎胞苷联合Venetoclax治疗安全耐受性良好。57例可进行疗效评估患者中,18例患者获得CR,22例获得骨髓完全缓解,11例患者疾病稳定,2例患者进展。中位至应答时间为1.0个月。中位应答持续时间(DOR)、PFS、OS均未达到,预估产生治疗应答患者的12个月DOR和PFS分别为74%和59%。预估18个月OS为74%。

Venetoclax单药或与阿扎胞苷联合治疗复发/难治性MDS

研究为Ib期研究,共入组46例患者,Venetoclax单药治疗组(C1)22例,Venetoclax联合阿扎胞苷治疗组(C2)24例。基线细胞遗传学好、中等、差的比例分别为44%、33%和22%。结果显示,Venetoclax单药或与阿扎胞苷联合安全耐受性良好。中位随访4.7个月,C1组的ORR为7%,75%的患者疾病稳定,中位至首次应答时间(TTR)为1.6个月,中位PFS为3.4个月,预估6个月OS为57%;C2组的ORR为50%,其中13%的患者获得CR,38%的患者获得骨髓CR,31%的患者疾病稳定。中位PFS和中位OS均未达到。预估6个月PFS为76%,预估9个月OS为83%。

阿扎胞苷联合RAS抑制剂Rigosertib一线治疗较高危MDS:II期研究

RAS通路突变在较高危(HR)MDS中常见,Rigosertib可与RAF激酶上的RAS结构域相结合,抑制RAS-RAF-MEK&PI3K通路。该II期研究旨在探讨标准剂量阿扎胞苷与口服RAS抑制剂Rigosertib联合一线治疗HR MDS的疗效和安全性。共入组39例患者,9例IPSS-R中位,8例高危,17例极高危(VHR)。结果显示,阿扎胞苷与口服RAS抑制剂Rigosertib联合安全耐受性良好。在29例可评估患者中,ORR(CR+PR+mCR+血象提升)为90%,CR/PR率为34%。IPSS-R细胞遗传学预后亚组分析显示,好、中等、差、极差组CR/PR率分别为25%、37.5%、25%和60%。IPSS-R预后分层分析显示,中危、高危和极高危的CR/PR率分别为25%、17%和42%。中位应答持续时间为12.2个月,中位治疗持续时间为8个月。至首次和最佳应答时间为1/4个月。

阿扎胞苷联合谷氨酰胺酶抑制剂Telaglenastat(CB-839)治疗进展期MDS:II期研究

研究为单臂Ib/II期研究,探讨阿扎胞苷联合谷氨酰胺酶抑制剂CB-839在中危和高危MDS中的安全性和疗效。共入组16例患者,12例(75%)为新诊断患者,4例患者此前接受过去甲基化治疗。8例(50%)患者为IPSS中危-2,8例患者为IPSS中危-1伴高危突变,6例(37.5%)患者染色体为复杂核型。结果显示,阿扎胞苷联合CB-839安全耐受性良好。中位至最佳应答时间为1个周期(1个周期中位时间29天),中位随访8.6个月,10例(62.5%)患者获得了mCR/HI,5例(31.3%)患者疾病稳定,1例患者未缓解。中位至mCR时间为2.5个月,中位OS和EFS分别为10.15个月和10.42个月。12例新诊断患者中,中位OS和EFS均未达到。伴TP53突变患者中mCR/HI比例为66.6%(4/6),复杂染色体核型中mCR/HI比例为83.3%(5/6)。

研究小结

阿扎胞苷是目前唯一证实可延长MDS患者总体生存的去甲基化药物,且具有毒副作用小,耐受性好的特点。本次ASH公布的多项研究显示阿扎胞苷联合其他药物有望进一步提升MDS的治疗效果。

有报道显示表观遗传学突变柠檬酸脱氢酶(IDH)突变可通过DNA甲基化促进疾病发展,因此IDH抑制剂和去甲基化药物联合应用,在不同水平阻碍疾病发展可能具有协同作用。本次ASH会议中,摘要为694的研究入组20例伴IDH1突变MDS患者,IDH1抑制剂olutasidenib联合阿扎胞苷治疗耐受性良好。中位治疗8个月后,olutasidenib和olutasidenib联合阿扎胞苷ORR为59%,两组的ORR分别为33%和73%,CR率分别为17%和55%。

临床前研究显示,BCL-2抑制剂venetoclax和阿扎胞苷在AML中具有协同作用。一项Ib期临床试验结果显示venetoclax联合去甲基化药物在老年AML中耐受性良好,疗效显着。本次ASH会议中两项口头报告(摘要号568、565)分别报告了venetoclax联合阿扎胞苷治疗未治疗和复发难治MDS的疗效,二者联合安全耐受性良好且近期缓解率高,远期疗效值得进一步观察,未来两种药物联合可能作为部分MDS患者的治疗选择。

本次ASH会议上,MDS治疗领域尤其阿扎胞苷联合其他药物治疗方面带来了很多值得期待的进展。未来在保证联合用药耐受性的基础上,期待药物联合可进一步提高治疗反应,延长患者的总体生存。值得注意的是,MDS异质性较大,且部分药物如IDH抑制剂只对有IDH突变的患者有治疗作用,因此未来临床应用时需注意筛选合适的患者。另外,MDS为老年性疾病,患者可同时有多种合并症,在确定治疗策略时需综合考虑合患者年龄、合并症等情况。

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    0

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