ASCO 2020:无处不在的曲妥珠单抗

2020-06-05 任冉 健康界

近日,靶向HER2的抗体偶联药物(ADC)DS-8201在胃癌上获得美国FDA授予的突破性疗法(BTD),并获得美国FDA授予在胃癌中的孤儿药称号。仔细翻一下今年ASCO大会,竟然有多达五个曲妥珠单抗

近日,靶向HER2的抗体偶联药物(ADC)DS-8201在胃癌上获得美国FDA授予的突破性疗法(BTD),并获得美国FDA授予在胃癌中的孤儿药称号。仔细翻一下今年ASCO大会,竟然有多达五个曲妥珠单抗相关的报告,排除掉两个还没有结论的,我们简单的看下这三个研究的结果和结论,如果有兴趣了解更多的话,扫描文章底部的二维码,我们会提供完整的大会报告ppt。

曲妥珠单抗deruxtecan(T-DXd; DS-8201)在患有HER2表达的转移性结直肠癌(mCRC)患者:DESTINY-CRC01的II期,多中心,开放标签研究中。

研究结果:

在数据截止(2019年8月9日)时,有78例(A,53; B,7; C,18)收到了T-DXd。中位年龄为58.5岁(范围为27-79岁),男性为52.6%,左结肠癌或直肠癌为89.7%;既往治疗方案的中位数为4(范围2-11);所有患者均已使用伊立替康。中位治疗持续时间为3.5 mo(95%CI,2.1-4.3 mo;队列A,4.8 mo [95%CI,3.9-5.8 mo]);T-DXd治疗仍保留38.5%的患者。队列A中确诊的ORR为45.3%(24/53分; CI为95%,为31.6%~59.6%),包括1个CR和23个PR。未达到中值DOR(95%CI,4.2 mo-NE)。先前接受过抗HER2治疗的患者的ORR为43.8%(7/16分; 95%CI,19.8%~70.1%)。DCR为83.0%(44/53分; 95%CI,70.2%~91.9%); PFS中位数为6.9 mo(95%CI,4.1 mo-NE); 未达到中位操作系统。在队列B或C中未观察到响应。61.5%的患者发生≥3级治疗紧急不良事件(TEAE)(48/78);最常见的(≥10%)是中性粒细胞减少(21.8%)和贫血(14.1%)。有7例患者(9.0%)的TEAE导致药物停用,5例患者(6.4%)有间质性肺病(ILD),经独立委员会判定与T-DXd有关(2级;1级3;2级5[唯一与药物有关的死亡])。

研究结论:

总体而言,T-DXd 6.4mg/kg q3w在标准治疗无效的HER2表达mCRC的pts中显示出显著的活性,其安全性与先前的结果一致。ILD是一种重要的风险,需要仔细的认识和干预。

曲妥珠单抗deruxtecan(T-DXd; DS-8201)在HER2阳性晚期胃或胃食管交界处(GEJ)腺癌患者中:一项随机,II期,多中心,开放标签研究(DESTINY-Gastric01)

研究结果:

187例患者接受了T-DXd(n = 125)或PC(n = 62 [55伊立替康; 7紫杉醇]);日本79.7%,韩国20.3%。患者中位有2个先前的治疗方案,44.4%的患者≥3个。截至数据截止(2019年11月8日),仍有22.4%的T-DXd和4.8%的PC患者继续接受治疗。

使用T-DXd的ORR为51.3%(61/119; 11 CR和50 PR),而使用PC的ORR为14.3%(8/56;全部PR)(P <.0001); 确认ORR为42.9%比12.5%(P <.0001); DCR为85.7%和62.5%(P = .0005); mDOR为11.3 比3.9 mo;mPFS为5.6 vs 3.5 mo(HR,0.47 [95%CI,0.31-0.71];P = .0003)。使用T-DXd可以显着延长OS(mOS,12.5比8.4 mo; HR,0.59 [95%CI,0.39-0.88];P = 0.0097 ;预先设定的O'Brien Fleming边界,P= .0202);12个月OS为52.1%B比28.9%。T-DXd患者发生AE≥3级的比例为85.6%,而PC患者为56.5%。最常见的是中性粒细胞计数下降(51.2%; 24.2%),贫血(37.6%; 22.6%)和白细胞计数下降(20.8%; 11.3%)。12例(9.6%)患有T-DXd相关性间质性肺疾病(ILD; 2级3级,1级4级,无5级),而PC组为0级。发生了1例与药物相关的死亡(T-DXd组中的肺炎[非ILD])。

研究结论:

与标准化疗(紫杉醇或伊立替康)相比,T-DXd在HER2 +晚期胃癌或GEJ腺癌患者中显示出ORR和OS的统计学显著性和临床意义的改善。

曲妥珠单抗deruxtecan(T-DXd; DS-8201)在HER2突变的转移性非小细胞肺癌(NSCLC)患者中:DESTINY-Lung01的中期结果。

研究结果:

数据截止2019年11月25日时,42例患者(64.3%女性)接受了T-DXd。中位年龄为63.0岁(范围34-83岁; <65岁,59.5%); 45.2%有中枢神经系统转移;23.8%的患者ECOG表现为0,而76.2%的患者为1。HER2突变主要位于激酶结构域(90.5%)。大多数患者(90.5%)曾接受铂类化学疗法,54.8%曾接受过抗PD-1或–PD-L1治疗。先前治疗的中位数为2(范围为1-6)。中位治疗时间为7.75 mo(范围0.7-14.3 mo);45.2%的患者仍在接受治疗。ICR证实的42例患者的ORR为61.9%(95%CI,45.6%-76.4%);数据截止时未达到中值DOR;26名应答者中有16名在数据截止时仍在接受治疗;DCR为90.5%(95%CI,77.4%-97.3%); 估计PFS中位数为14.0 mo(95%CI,6.4-14.0 mo)。所有患者(42/42)均出现治疗紧急不良事件(TEAE)。≥3级者占64.3%(与药物有关为52.4%),其中中性粒细胞减少(26.2%)和贫血(16.7%)。经独立委员会裁决的药物相关性间质性肺病(ILD)5例(11.9%),均为2级、无≥3级。1例为1级。TEAEs导致25例(59.5%)的剂量中断,16例(38.1%)的剂量减少和10例患者(23.8%)的治疗中断。

研究结论:

T-DXd在具有HER2突变的NSCLC的患者中表现出具有高ORR和持久反应的良好临床活性。期安全性概况通常与先前报道的研究一致。

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    2021-03-16 quxin068
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    2020-06-06 lovetcm

    #T-DM1#曲妥珠单抗deruxtecan,ADC类药物的便捷性和效果,与联用的灵活性如何选择?

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    2020-06-06 lovetcm

    #T-DM1#他的未来前景你怎么看?

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