第一金融网主办
»您现在的位置: 第一金融网 >> 财经金融 >> 文传商讯 >> 正文

Samsung Bioepis Announces Phase 3 Results of SB8, Bevacizumab Biosimilar Candidate, at the European Society for Medical Oncology (ESMO) 2019 Congress

2019/9/30 8:22:37  文章来源:文传商讯  作者:文传商讯
文章简介: InaPhase3study,SB8demonstratedequivalentefficacyintermsofriskratioofoverallresponserate(ORR)toreferencebevacizumabAVASTINiinpatientswit

In a Phase 3 study, SB8 demonstrated equivalent efficacy in terms of risk ratio of overall response rate (ORR) to reference bevacizumab AVASTIN i in patients with metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC)
Safety, pharmacokinetics, and immunogenicity were also comparable
Marketing authorization application for SB8 accepted for review by the European Medicines Agency (EMA)

INCHEON, Korea -- (BUSINESS WIRE) --

Samsung Bioepis Co., Ltd. today announced results from the Phase 3 study evaluating the efficacy and safety of SB8, a bevacizumab biosimilar candidate, compared to reference bevacizumab in patients with metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC).ii The study results will be presented for the first time today at the European Society for Medical Oncology (ESMO) 2019 Congress in Barcelona, Spain.

“Data from this study showed that there were no clinically meaningful differences between SB8 and reference bevacizumab in terms of efficacy, safety, pharmacokinetics and immunogenicity,” said Chul Kim, Senior Vice President and Head of Clinical Sciences Division, Samsung Bioepis. “We are committed to increasing access to high-quality, life-changing oncology medicines through the development of biosimilars to address some of oncology’s most pressing challenges.”

The primary endpoint of the study was the overall response rate (ORR) by 24 weeks; risk ratio was analyzed in the full analysis set (FAS) with pre-defined equivalence margin of 0.737 to 1.357 and the risk difference was analyzed in the per-protocol set (PPS) with pre-defined equivalence margin of ±12.5%. The ORR in FAS was 47.6% for SB8 and 42.8% for reference bevacizumab; the risk ratio was 1.11 (90% CI: 0.975, 1.269). The ORR in PPS was 50.1% for SB8 and 44.8% for reference bevacizumab; the risk difference was 5.3% (95% CI: −2.2%, 12.9%). The median progression-free survival (8.5 months vs 7.9 months) and overall survival (14.9 months vs. 15.8 months) were comparable between SB8 and reference bevacizumab. The overall incidence of treatment-emergent adverse events (92.1% vs 91.1%) and the incidence of overall anti-drug antibodies (16.1% vs 11.0%) were also comparable between SB8 and reference bevacizumab.

Marketing Authorization Application (MAA) for SB8 was accepted for review by the European Medicines Agency (EMA) in July 2019.

The results of the SB8 Phase 3 study will be presented as a poster during ESMO as follows: [1565P] 12:00-13:00, September 28, Hall 4. Samsung Bioepis will also host a satellite symposium, titled ‘Quality Assurance to Optimize HER2+ Breast Cancer Treatment’, which will discuss the importance of quality maintenance in oncology biologics. The symposium will take place between 13:00-14:30 on September 30, 2019 in Toledo Auditorium, Hall 5, Fira Gran Via, Barcelona. Topics include:

  • Building confidence in biosimilars
  • Acknowledging importance of biologics quality in clinical practice
  • Reassuring biosimilarity based on clinical evidence
  • Interactive discussion: perspective on biosimilars in oncology

SB8 Phase 3 Study

The SB8 Phase 3 study is a randomized, double-blind, multicenter study evaluating the efficacy, safety, pharmacokinetics (PK), and immunogenicity of SB8 compared to reference bevacizumab in combination with paclitaxel and carboplatin in patients with metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC). 763 patients were randomized (1:1) to receive SB8 or reference bevacizumab with paclitaxel and carboplatin Q3W followed by SB8 or reference bevacizumab maintenance therapy until disease progression, unacceptable toxicity, death, or 1 year from the randomization of the last patient. The primary endpoint is the overall response rate (ORR) which is defined as the proportion of patients whose best overall response by 24 weeks is either complete response or partial response. Secondary endpoints were progression free survival (PFS), overall survival (OS), duration of response (DOR), safety, PK, and immunogenicity.

About Samsung Bioepis Co., Ltd.

Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biosimilar candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology and hematology. Samsung Bioepis is a joint venture between Samsung BioLogics and Biogen. For more information, please visit: www.samsungbioepis.com.

_____________________________

i AVASTIN is a registered trademark of Genentech Inc.

ii Reck et al. A Phase III Study comparing SB8, a Proposed Bevacizumab Biosimilar, and Reference Bevacizumab in Patients with Metastatic or Recurrent Non-squamous NSCLC. ESMO 2019, Barcelona, Spain [1565P]

View source version on businesswire.com: https://www.businesswire.com/news/home/20190926005378/en/

CONTACT:

Na Yun KIM
+82-31-8061-1604
nayun86.kim@samsung.com

分享到:
第一金融网免责声明:
1、本网站中的文章(包括转贴文章)的版权仅归原作者所有,若作者有版权声明的或文章从其它网站转载而附带有原所有站的版权声明者,其版权归属以附带声明为准。
2、文章来源为均为其它媒体的转载文章,我们会尽可能注明出处,但不排除来源不明的情况。转载是处于提供更多信息以参考使用或学习、交流、科研之目的,不用于 商业用途。转载无意侵犯版权,如转载文章涉及您的权益等问题,请作者速来电话和函告知,我们将尽快处理。来信:fengyueyoubian#sina.com (请将#改为@)。
3、本网站所载文章、数据、网友投稿等内容纯属作者个人观点,仅供投资者参考,并不构成投资建议,与第一金融网站无关。投资者据此操作,风险自担。如对本文内容有疑义,请及时与我们联系。
发表评论

【发表评论】(网友评论内容只代表网友观点,与本站立场无关!)
 姓 名:
 评 分: 1分 2分 3分 4分 5分
 评论内容:
验证码:   *
  • 请遵守《互联网电子公告服务管理规定》及中华人民共和国其他各项有关法律法规。
  • 严禁发表危害国家安全、损害国家利益、破坏民族团结、破坏国家宗教政策、破坏社会稳定、侮辱、诽谤、教唆、淫秽等内容的评论 。
  • 用户需对自己在使用本站服务过程中的行为承担法律责任(直接或间接导致的)。
  • 本站管理员有权保留或删除评论内容。
  • 评论内容只代表网友个人观点,与本网站立场无关。
  • 全站精选
    [新闻]  10月起一批新规将正式实施 对你我生活产生哪些影
     央行暂停逆回购操作 此前强调“把好货币供给总闸
    [银行]  2019银行概念股票一览?财政部新规引发银行股飘
     2019银行从业资格证报名时间 报名需要什么条件?
    [股票]  6张图看清A股估值:中证500市盈率24.5 创业板综指
     10月不缺剧情!几路资金悄然买入这些股(名单)
    [基金]  基民"嗨了"!这20只基金狂赚70%以上,前三季度冠
     社保基金再度壮大具体什么情况?究竟是怎么一回
    [保险]  人保车险理赔时间规定
     职工医保和新农合医保哪个好?主要看这三点
    [期货]  原油暴涨暴跌波及化工产业 去年苯乙烯价差超600
     沙特油田遭无人机袭击 美布两油暴涨
    [股评]  机构强推买入 六股成摇钱树(9/30)
     下周一机构一致看好的十大金股(9/30)
    [港股]  港股通中秋休市安排2019:开市时间9月16日起
     阿里20亿美元全资收购网易考拉并领投网易云音乐
    [美股]  百度卖携程股份,价值十亿美元
     WeWorkceo离职怎么回事?还拟裁员5000!WeWork还
    [外汇]  华尔街突遭“美元荒” 本周重点关注欧美制造业P
     17日人民币对美元汇率中间价下调73个基点
    [债券]  2019国庆假期国债逆回购时间表 让你小长假躺着赚
     中国10年国债收益率 今年波幅七年来最小
    [黄金]  2020庚子鼠年贺岁银条哪里预约?怎么购买?
     中国为何不把存美国黄金运回?因为美国不敢私吞
    [理财]  微信支付宝绑定银行卡的 赶紧删了手机里这些照片
     组图:网友前置摄像头跟拍那英 疑似惹对方不满遭
    [信托]  跌破8% 集合信托收益或继续下跌
     信托违约增多 预期收益9%的产品还能买吗?
    [房产]  陕西秦岭保护再升级:违建最高罚两百万
     榜单:6家房企信用评级上调 超7成债券获AAA评级
    [汽车]  4年亏损220亿,蔚来迎战艰难时刻
     10月25日上市! 丰田全新RAV4配多种动力系统
  • 此栏目下没有推荐文章
  • | 设为首页 | 加入收藏 | 关于我们 | 友情链接 | 版权申明 | 文章列表 | 网站地图 | 征稿启事 | 广告服务 | 意见反馈 |

    Copyright©2006-2027 afinance.cn All Rights Reserved 版权所有·第一金融网 ,未经授权禁止复制或建立镜像,否则将依法追究法律责任!

    声明:我们不做任何形式的代客理财及投资指导,凡是以第一金融网名义做股票推荐的行为均属违法!

    广告商的言论与行为均与第一金融网无关!股市有风险,投资需谨慎。

    合作邮箱:fengyueyoubian@sina.com 合作电话:18678839953 点击这里给我发消息