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Phase 3 PROCEED Trial of Vintafolide Halted
Vintafolide, jointly being developed by Merck and Endocyte, failed to present efficacy on PFS in Phase 3 trials, resulting in early termination.
Merck, known as MSD outside the United States and Canada (NYSE: MRK), 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 are conducted, the Companies have taken steps to notify investigators that screening and randomization of participants in the trial will be suspended.
Press release:
Source: Endocyte