您现在的位置: 生物谷 > 生物制药 > 新药研发 > 正文

默沙东终止抗癌药vintafolide卵巢癌III期PROCEED研究

2014年5月2日讯 /生物谷BIOON/ --默沙东(Merck & Co)和Endocyte公司5月2日宣布,数据安全监督委员会(DSMB)已完成对PROCEED试验的一项既定中期分析,该委员会建议终止该项研究,因为vintafolide在铂耐药卵巢癌中未能改善疾病无进展生存期(PFS)。DSMB未发现任何安全性问题。基于DSMB的意见,默沙东和Endocyte已决定终止该项研究。目前,默沙东正在开展进一步的数据审查。

PROCEED是一项随机、双盲III期试验,在叶酸受体阳性、铂耐药卵巢癌患者中开展,将vintafolide+聚乙二醇化脂质体阿霉素(PLD)联合疗法与PLD+安慰剂进行了对比。研究中,利用etarfolatide显像剂(一种靶向叶酸的分子显像剂)确定患者为叶酸受体阳性卵巢癌。研究主要终点是疾病无进展生存期(PFS),以实体瘤治疗疗效评价标准(RECIST)衡量。次要终末点为总生存期(OS)。etarfolatide是一种非侵入性诊断显像剂,用于识别叶酸受体阳性肿瘤细胞。

2012年4月,默沙东与Endocyte公司签署10亿美元协议,获得了处于后期开发阶段的卵巢癌药物vintafolide(EC145)的全部权利。该笔交易包括1.2亿美元的预付款,在达到用于6种癌症治疗的开发、监管及商业化里程碑后,更将获得高达8.8亿美元的里程碑款项。

2012年3月,欧盟授予vintafolide孤儿药地位。(生物谷Bioon.com)

英文原文:Merck and Endocyte Announce Independent DSMB Recommends Vintafolide PROCEED Phase 3 Trial Be Stopped for Futility Following Interim Analysis

WHITEHOUSE STATION, N.J. & WEST LAFAYETTE, Ind.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, and Endocyte, Inc. (NASDAQ:ECYT), today announced that the Data Safety Monitoring Board (DSMB) of the PROCEED trial has completed a pre-specified, interim futility analysis and the DSMB recommended that the trial be stopped because vintafolide did not demonstrate efficacy on the pre-specified outcome of Progression-Free Survival (PFS) in patients with platinum-resistant ovarian cancer. The DSMB did not identify any safety concerns for the patients enrolled in the trial. Based on the DSMB recommendation and while further review of the data is conducted, the Companies have taken steps to notify investigators that screening and randomization of participants in the trial will be suspended.

PROCEED is a Phase 3 randomized, double-blind clinical trial, evaluating vintafolide in combination with pegylated liposomal doxorubicin (PLD) compared to PLD plus placebo for the treatment of folate receptor-positive, platinum-resistant ovarian cancer. The primary endpoint of the trial was PFS as measured by RECIST v 1.1 (Response Evaluation Criteria In Solid Tumor) criteria in patients with all target tumor lesions positive as assessed by etarfolatide imaging agent.

About Merck

Today’s Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships.

About Endocyte

Endocyte is a biopharmaceutical company and leader in developing targeted small molecule drug conjugates (SMDCs) and companion imaging agents for personalized therapy in cancer and other serious diseases. Endocyte uses its proprietary technology to create novel SMDCs and companion imaging agents for personalized targeted therapies. The company's SMDCs actively target receptors that are expressed or over-expressed on diseased cells, relative to healthy cells. This targeted approach is designed to enable the treatment of patients with highly potent drugs into these cells. The companion imaging agents are designed to identify patients whose disease expresses the molecular target of the therapy and who therefore may be more likely to benefit from treatment.

关键词:默沙东,Endocyte,vintafolide,叶酸受体阳性,卵巢癌,显像剂,etarfolatide

信息来源:生物谷