Merck and Endocyte pull CMA for vintafolide and companion imaging component in EU

US pharma giant Merck & Co (NYSE: MRK) and Endocyte (Nasdaq: ECYT) have withdrawn their conditional marketing authorization applications (CMA) from the European Medicines Agency for vintafolide and companion imaging components, imaging agent etarfolatide and intravenous (IV) folic acid, for the treatment of adult patients with folate receptor-positive, platinum-resistant ovarian cancer, in combination with pegylated liposomal doxorubicin (PLD).

The companies’ decision was based on further review of interim data from the PROCEED trial. Study enrollment was suspended earlier this month based on the Data Safety Monitoring Board’s (DSMB) recommendation that the study be stopped because vintafolide in combination with PLD versus PLD alone did not meet the pre-specified criteria for progression-free survival to allow continuation of the study (The Pharma Letter May 3). That news caused Endocyte’s share to nose dive 62% to $6.65. The firm’s shares fell 6% in after-hours trading to $6.10 last night. Merck acquired rights to the drug in a licensing deal worth up to $1 billion in 2012.

The DSMB did not identify any safety concerns for the patients enrolled in the PROCEED trial. The companies will take steps to terminate the PROCEED trial and will provide investigators with instructions to conclude the trial. The study results will be presented in a future scientific congress.