默克公司的派姆单抗与化疗联用在早期三阴性乳腺癌(TNBC)试验中有显著疗效
来源:本站原创 2019-10-01 10:26
默克公司也被称为M默沙东,今天宣布了关键的新辅助疗法在早期三阴性乳腺癌(TNBC)KEYNOTE-522试验3期中的结果。该试验研究了默克公司的新辅助疗法:抗PD-1疗法KEYTRUDA联合化疗的方案。该方案采用抗PD-1疗法KEYTRUDA联合化疗再使用辅助疗法KEYTRUDA作为单一疗法(KEYTRUDA方案)。与其相比的方案采用了新辅助化疗后采用了辅助安慰剂(化疗-安慰剂方案)。针对三阴性乳
默克公司也被称为M默沙东,今天宣布了关键的新辅助疗法在早期三阴性乳腺癌(TNBC)KEYNOTE-522试验3期中的结果。该试验研究了默克公司的新辅助疗法:抗PD-1疗法KEYTRUDA联合化疗的方案。该方案采用抗PD-1疗法KEYTRUDA联合化疗再使用辅助疗法KEYTRUDA作为单一疗法(KEYTRUDA方案)。与其相比的方案采用了新辅助化疗后采用了辅助安慰剂(化疗-安慰剂方案)。针对三阴性乳腺癌(TNBC)的新辅助/佐剂环境中抗PD-1治疗的第一项随机试验的临时结果今天将在欧洲医学肿瘤学会(ESMO)2019年大会上发表。![Image result for KEYTRUDA®](data:image/png;base64,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)
在新辅助阶段,KEYTRUDA联合化疗(n = 401)相对于化疗(n = 201)的在早期TNBC患者中显着地增加病理完全缓解(pCR),从新辅助化疗的51.2%增至新辅助KEYTRUDA联合化疗的64.8%(P=0.00055)。病理学完全缓解是双重主要终点之一,被定义为ypT0 /Tis ypN0(即在乳腺和淋巴结中无浸润性残留癌)。无论患者的PD-L1表达如何,研究员可以观察到将KEYTRUDA添加到新辅助化疗中后所引起的改善。随访了15.5个月后,在另一个双重主要终点:无事件生存率(EFS)的研究中,研究员发现KEYTRUDA方案将新辅助期进展和辅助期复发的风险与化疗-安慰剂方案相比降低了37%(HR = 0.63 [95%CI,0.43-0.93])。KEYNOTE-522中KEYTRUDA和化学疗法的安全性与以前的研究一致。
默克研究实验室总裁Roger M. Perlmutter博士说:“这项创新性试验是第一个将新辅助和KEYTRUDA辅助治疗结合使用来治疗早期TNBC患者。今天报道的KEYNOTE-522研究结果令人鼓舞,并且有可能改变诊断为TNBC的患者的治疗方法。”
巴茨癌症研究所实验癌症医学中心主任彼得·施密德博士说:“作为一名专门研究TNBC的肿瘤学家,在新辅助治疗中,KEYTRUDA联合化疗显着改善了pCR率,并且无事件生存率的积极趋势令我倍受鼓舞。我们迫切需要可以增加该患者人群中pCR率的新治疗方案。”
如先前宣布的那样,KEYTRUDA加化学疗法被美国食品和药物管理局(FDA)授予“突破疗法”称号(BTD),用于高危早期TNBC患者的新辅助治疗。根据来自1b期KEYNOTE-173期和2期I-SPY2期试验的数据FDA批准了BTD,该试验证明了在这些患者中使用新辅助KEYTRUDA联合化疗可激发令人鼓舞的抗肿瘤活性。
三阴性乳腺癌基金会”执行董事海莉·迪纳曼说:“ KEYNOTE-522试验的这些发现对于TNBC社区来说是令人兴奋的,TNBC社区特别需要科学进步。我们致力于为TNBC患者提供支持,我们很高兴看到有关早期治疗方法的新数据。”
正如先前宣布的那样,默克计划与监管机构共享KEYNOTE-522的早期中期分析数据。 该公司将继续为KEYTRUDA制定一项强有力的乳腺癌临床开发计划,该计划包括多项内部研究和外部合作试验,包括KEYNOTE-355和KEYNOTE-242。(生物谷\Bioon.com)
原文出处:默克官网
版权声明 本网站所有注明“来源:生物谷”或“来源:bioon”的文字、图片和音视频资料,版权均属于生物谷网站所有。非经授权,任何媒体、网站或个人不得转载,否则将追究法律责任。取得书面授权转载时,须注明“来源:生物谷”。其它来源的文章系转载文章,本网所有转载文章系出于传递更多信息之目的,转载内容不代表本站立场。不希望被转载的媒体或个人可与我们联系,我们将立即进行删除处理。
87%用户都在用生物谷APP 随时阅读、评论、分享交流 请扫描二维码下载->
![](https://cdn1.bioon.com/images/qcode.png)