• 主题
高级搜索  >
历史搜索 清空历史
首页> 美国卫生研究院文献>ESMO Open >European Medicines Agency extension of indication to include the combination immunotherapy cancer drug treatment with nivolumab (Opdivo) and ipilimumab (Yervoy) for adults with intermediate/poor-risk advanced renal cell carcinoma
【2h】

European Medicines Agency extension of indication to include the combination immunotherapy cancer drug treatment with nivolumab (Opdivo) and ipilimumab (Yervoy) for adults with intermediate/poor-risk advanced renal cell carcinoma

机译：欧洲药物局局长延长含有中间/贫困肾细胞癌的成人与Nivolumab（Opdivo）和Ipilemimab（Yervoy）的组合免疫治疗药物治疗药物治疗

代理获取
本网站仅为用户提供外文OA文献查询和代理获取服务，本网站没有原文。下单后我们将采用程序或人工为您竭诚获取高质量的原文，但由于OA文献来源多样且变更频繁，仍可能出现获取不到、文献不完整或与标题不符等情况，如果获取不到我们将提供退款服务。请知悉。
页面导航
  • 摘要
  • 著录项
  • 相似文献
  • 相关主题

摘要

On the 15 November 2018, the Committee for Medicinal Products for Human Use adopted an extension to an existing indication for the use of nivolumab (Opdivo) in combination with ipilimumab (Yervoy) for the first-line treatment of adult patients with intermediate/poor-risk advanced renal cell carcinoma (RCC). The approval was based on results from the Pivotal {"type":"entrez-nucleotide","attrs":{"text":"CA209214","term_id":"35251268","term_text":"CA209214"}}CA209214 study, a randomised, open-label, phase III study, comparing nivolumab +ipilimumab with sunitinib in subjects≥18 years of age with previously untreated advanced RCC (not amenable for surgery or radiotherapy) or metastatic RCC, with a clear-cell component. A total of 1096 patients were randomised in the trial, of which 847 patients had intermediate/poor-risk RCC and received either nivolumab (n=425) in combination with ipilimumab administered every 3 weeks for 4 doses followed by nivolumab monotherapy 3 mg/kg every 2 weeks or sunitinib (n=422) administered orally for 4 weeks followed by 2 weeks off, every cycle. A statistically significant difference in overall survival (OS) was observed in the nivolumab + ipilimumab group compared with the sunitinib group in intermediate/poor-risk subjects (HR 0.63 (99.8% CI 0.44 to 0.89); stratified log-rank 2-sided p-value<0.0001). The median OS was not reached for the nivolumab + ipilimumab group and was 25.95 months for the sunitinib group. The OS rates were 89.5% and 86.2% at 6 months, and 80.1% and 72.1% at 12 months in the nivolumab +ipilimumab and the sunitinib groups, respectively. K-M curves separated after approximately 3 months, favouring nivolumab + ipilimumab. This was not mirrored in the favourable-risk patients where no statistically significant difference was observed between nivolumab + ipilimumab and sunitinib in favourable-risk patients (HR 1.45 (descriptive 99.8% CI 0.51 to 4.12), p =0.2715).
机译：在2018年11月15日，用于人类使用的药物委员会通过了延长了现有指示用于使用Nivolumab（Opdivo）与Ipilimumab（Yervoy）组合用于中级/穷人的成人患者的一线治疗风险晚期肾细胞癌（RCC）。批准基于关键{“类型”：“entrez-nucleotide”，“attrs”：{“text”：“ca209214”，“term_id”，“35251268”，“term_text”：“ca209214”}}。 CA209214研究，随机开放标签，第三阶段研究，将Nivolumab + IpiLimumab与Sunitinib在≥18岁的受试者中，具有先前未经治疗的晚期RCC（不适合手术或放射疗法）或转移RCC，具有透明细胞组分。在试验中，共有1096名患者随机化，其中847名患者具有中间/贫困风险RCC，并在每3周给予每3周给药后的IPILUMAB（n = 425），其次用Nivolumab单药治疗3mg / kg组合。每2周或仙烟蛋白（n = 422）口服施用4周，然后休息2周，每个周期。与中间/贫瘠受试者中的孙氨硅基团（HR 0.63（99.8％0.44至0.89）相比，在Nivolumab + Ipilimalab组中观察到整体存活率（OS）的统计学上显着差异;分层对数排名双面P. -Value <0.0001）。 Nivolumab + Ipilimumab组未达到中位操作系统，为Sunitinib集团为25.95个月。在Nivolumab + Ipilimumab和Sunitinib组中，OS率在6个月内为89.5％和86.2％，和80.1％和72.1％。 K-M曲线在约3个月后分离，有利于Nivolumab + Ipilimumab。这在有利风险的患者中没有镜像，在良好的风险患者中没有观察到Nivolumab + Ipilemimab和Sunitinib之间没有统计学显着差异（HR 1.45（描述性99.8％CI 0.51至4.12），p = 0.2715）。

著录项

相似文献

  • 外文文献
  • 专利
代理获取

客服邮箱：kefu@zhangqiaokeyan.com

京公网安备：11010802029741号 ICP备案号：京ICP备15016152号-6 六维联合信息科技 (北京) 有限公司©版权所有

  • 客服微信

  • 服务号