罗氏Tecentriq联合紫杉醇用于三阴性乳腺癌研究主要终点PFS未能达到

2020-08-07 Allan MedSci原创

罗氏今日宣布,抗PD-L1抗体Tecentriq(atezolizumab)与紫杉醇联合治疗转移性三阴性乳腺癌(TNBC)的III期临床试验(IMpassion131研究)未能显著改善PFS。

罗氏今日宣布,抗PD-L1抗体Tecentriq(atezolizumab)与紫杉醇联合治疗转移性三阴性乳腺癌(TNBC)的III期临床试验(IMpassion131研究)未能显著改善无进展生存期(PFS)。这些患者均为PD-L1阳性人群。该公司指出,正在与全球卫生当局讨论IMpassion131试验的全部结果。

这项研究随机分配了651例未经治疗、无法手术、局部晚期或转移性TNBC患者,患者接受Tecentriq或安慰剂,并与紫杉醇联合使用。该试验的主要终点是PD-L1阳性人群的PFS,而次要目标包括PD-L1阳性人群和意向性治疗人群的总体生存率(OS)、总体缓解率(ORR)和缓解持续时间。罗氏指出,尽管在分析时OS的数据还不成熟,该制药商表示,计划继续进行OS随访,直到进行最终分析为止。

罗氏全球产品开发部负责人Levi Garraway表示:“今天的结果强调,需要更好地了解癌症和免疫系统之间的相互作用,包括化学疗法和相关疗法”。在先前的IMpassion130研究中,Tecentriq与百时美施贵宝(Bristol Myers Squibb)的Abraxane(nab-paclitaxel)联合使用显示出了显著的PFS益处,并且对PD-L1阳性转移性TNBC患者显示了OS的显著改善。

 

梅斯医学小编也认为,IMpassion131在PFS上的失利表明,PD-L1联合白蛋白紫杉醇对于TNBC而言,是优化的选择,因此,IMpassion130获得了相当理想的效果。但是,如果换用常规紫杉醇,由于常规紫杉醇使用时需要同时使用大剂量的激素,对免疫系统可能具有一定的抑制作用,可能会减弱免疫治疗的效果,这是IMpassion131未能获益的关键原因之一。因此,在今后的TNBC的治疗方案中,仍然应该选择PD-L1联合白紫,作为优化的方案。

当然,TNBC仍然是痼疾。在IMpassion130研究中显示,PD-L1阳性的患者群体中,试验组和对照组的PFS分别为7.5个月和5.0个月,虽然统计学差异极为显著,但是,不管哪一组的PFS仍然不足够高。未来仍然需要探索PD-1/PD-L1联合优化的化疗方案,例如是否可以在白紫基础上,再增加化疗药物,或在PD-L1基础上,再增加免疫治疗药物?也许都是未来的探索方向。

附:IMpassion130临床研究

IMpassion130是乳腺癌免疫治疗领域开展的一项重要的多中心临床研究,这项研究目前取得了比较好的结果,也可以说是我们在三阴性乳腺癌或者整个乳腺癌治疗领域取得的一个突破性的进展。该研究入组了902例不可手术的局部晚期或者转移性乳腺癌患者,1:1随机接受一线阿特利珠单抗联合白蛋白紫杉醇治疗对比安慰剂联合白蛋白紫杉醇治疗,主要研究终点包括PFS和OS。

 

IMpassion130临床研究设计及数据检测

此项研究的特殊性在于它的统计学设计,它平行检验了ITT人群和PD-L1阳性这两组人群的PFS的水平。而对于OS是按层级进行检验,先检验ITT人群,获得阳性结果后再针对其中PD-L1阳性人群的OS数据进行进一步分析。这样的检验方法优点在于很大程度上能减少对p值的消耗,控制样本量,增加研究进度。伴随的风险就是,如果首先检验的ITT人群没有统计学差异,后续的PD-L1阳性人群就无法正式检验。但是此研究设计巧妙,对临床研究有一定的促进作用。

IMpassion130的研究结果显示在ITT人群中,实验组和对照组的PFS分别为7.2个月和5.5个月;而在PD-L1阳性的患者群体中,PFS的差异更明显,实验组和对照组的PFS分别为7.5个月和5.0个月,而且都有显著的统计学差异,所以说患者PFS的获益是非常明确的。之所以研究设计不先检验PD-L1+人群是因为在IMpassion130之前,阿替利珠单抗只有两个Ⅰ期研究,其中与白蛋白紫杉醇联合治疗的GP28328研究只有32例三阴性乳腺癌患者,信息量相对较少,还无法真正判断PD-L1对免疫治疗的指导意义,而且PD-L1人群的比例只有40%多一点,基于样本量的原因,先检验PD-L1人群同样要冒很大的风险。所以在最初设计的时,我们还是先以ITT人群作为一个主要研究终点。

研究数据出来之后,我们的认识发生了改变,我们知道了PD-L1阳性人群获益不仅在PFS上,OS数据也提示PD-L1+的患者人群获益更大,所以在未来的临床研究中,我们可以考虑用PD-L1+作为主要研究终点的优势亚型。除了IMpassion130之外,我国目前还在开展另一个阿替利珠单抗联合紫杉醇的多中心Ⅲ期临床研究(IMpassion131研究)。IMpassion130的研究结果公布之后,IMpassion131很快就进行了方案修订,主要研究终点由原来的只看ITT人群的PFS改为先看PD-L1+人群的PFS,样本量也相应的从495例增加到了600例。

原始出处:

https://www.firstwordpharma.com/node/1747348?tsid=4

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    2020-09-11 ms7000001505175733

    学习下

    0

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    2020-10-15 shock_melon
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    2020-08-09 jeanqiuqiu
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    2020-08-09 xlysu
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    2020-08-09 lfyang
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    2020-08-07 619103330

    学习了

    0

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Cancer Discov:三阴性乳腺癌新疗法——BBOX1抑制剂

与其它呈激素受体或HER2阳性的癌症不同,三阴性乳腺癌几乎无靶向疗法可用,只能依靠手术、化疗和放疗来进行治疗,但效果不如靶向治疗,会伤害健康组织。研究发现BBOX1可以作为三阴性乳腺癌的可行治疗靶点。

Cell Res :复旦大学发布三阴性乳腺癌精准治疗方案,让患者从山穷水尽到柳暗花明

三阴性乳腺癌是所有乳腺癌中的一种,因雌激素受体、孕激素受体和HER-2三个主要治疗靶点均为阴性而被称为“三阴”,约占所有乳腺癌的15%左右。这种乳腺癌由于缺乏靶点、复发转移风险高,被认为最毒、最凶险。

Cancer Dis:三阴性乳腺癌靶向治疗新突破!BBOX1基因是关键!

导言:三阴性乳腺癌(TNBC)约占所有乳腺癌的15-20%,以分化差、侵袭性高、易转移著称。在精准治疗时代,三阴性乳腺癌因无具体的靶点,往往以化疗为主,临床治疗比较棘手。有效的治疗靶点一直是学界的世界

Clini Cancer Res:PD-L1表达与三阴性乳腺癌新辅助化疗预后的相关性

既往研究表明三阴性乳腺癌患者可从PD-1轴免疫疗法中获益。因此,本研究评估PD-L1在肿瘤细胞和免疫细胞上的表达与TNBC患者采用新辅助度伐单抗联合化疗获益的相关性。

拓展阅读

Nature子刊:三阴性乳腺癌的罕见亚型有哪些分子特征?

本文回顾了化生性、三阴性小叶、乳腺大汗腺分化癌、腺样囊性、分泌性和高级别神经内分泌TNBC的流行病学、组织学以及临床和分子特征。

Nat. Commun | 单臂II期临床试验:卡瑞利珠单抗联合白蛋白紫杉醇和表柔比星新辅助治疗早期三阴性乳腺癌

该研究旨在评估新辅助卡瑞利珠单抗联合化疗在早期TNBC患者中的疗效和安全性,新辅助卡瑞利珠单抗联合化疗在早期TNBC患者中显示出良好的抗肿瘤活性和可控的安全性。

成中医李小芳/罗开沛《Small》:双靶向脂质体增强三阴性乳腺癌化学免疫治疗

诱导ICD并抑制STAT3,有望增强免疫原性,逆转免疫抑制。

Nat. Commun | 紫杉醇加卡铂和度伐利尤单抗联合或不联合oleclumab用于治疗既往未经治疗的局部晚期或转移性三阴性乳腺癌女性:随机SYNERGY I/II 试验

该研究旨在探索抗CD73单抗oleclumab联合化疗和抗PD-L1单抗度伐利尤单抗在未经治疗的三阴性乳腺癌患者中的安全性和疗效,该研究未达到主要终点。

JAMA Oncol | 新辅助帕博利珠单抗加卡铂和多西他赛治疗三阴性乳腺癌的临床和生物标志物结果:NeoPACT 2期临床试验

该研究旨在评估卡铂、多西他赛和帕博利珠单抗联合应用在早期三阴性乳腺癌患者新辅助治疗中的疗效,研究结果支持将非蒽环类新辅助化疗联合帕博利珠单抗方案作为化疗降级策略进行进一步随机对照研究。

Nat. Commun:抗PD-L1/CTLA-4双特异性抗体KN046联合白蛋白结合型紫杉醇一线治疗转移性三阴性乳腺癌:多中心II期试验

该研究旨在评估KN046联合白蛋白结合型紫杉醇在初治晚期TNBC中的疗效和安全性,联合方案在一线治疗晚期三阴性乳腺癌中展现出良好的疗效和安全性,尤其对PD-L1阳性患者更为显著。