2014年5月2日訊 /生物谷BIOON/ --默沙東（Merck & Co）和Endocyte公司5月2日宣布，數據安全監督委員會（DSMB）已完成對PROCEED試驗的一項既定中期分析，該委員會建議終止該項研究，因為vintafolide在鉑耐藥卵巢癌中未能改善疾病無進展生存期（PFS）。DSMB未發現任何安全性問題。基於DSMB的意見，默沙東和Endocyte已決定終止該項研究。目前，默沙東正在開展進一步的數據審查。
PROCEED是一項隨機、雙盲III期試驗，在葉酸受體陽性、鉑耐藥卵巢癌患者中開展，將vintafolide+聚乙二醇化脂質體阿黴素（PLD）聯合療法與PLD+安慰劑進行了對比。研究中，利用etarfolatide顯像劑（一種靶向葉酸的分子顯像劑）確定患者為葉酸受體陽性卵巢癌。研究主要終點是疾病無進展生存期（PFS），以實體瘤治療療效評價標準（RECIST）衡量。次要終末點為總生存期（OS）。etarfolatide是一種非侵入性診斷顯像劑，用於識別葉酸受體陽性腫瘤細胞。
2012年4月，默沙東與Endocyte公司籤署10億美元協議，獲得了處於後期開發階段的卵巢癌藥物vintafolide（EC145）的全部權利。該筆交易包括1.2億美元的預付款，在達到用於6種癌症治療的開發、監管及商業化裡程碑後，更將獲得高達8.8億美元的裡程碑款項。
2012年3月，歐盟授予vintafolide孤兒藥地位。（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.