Merck and Endocyte Withdraw Conditional Marketing Authorization Applications for Vintafolide and Companion Imaging Components, Etarfolatide and Intravenous Folic Acid in Europe

Merck (known as MSD outside the US and Canada), and Endocyte, Inc. have announced the withdrawal of conditional marketing authorization applications (CMA) from the European Medicines Agency (EMA) 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 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.  

“Advanced stage ovarian cancer is a difficult-to-treat disease with few options available, and we are disappointed by the outcome of this confirmatory study. We would like to thank our clinical investigators and especially the patients with platinum-resistant ovarian cancer who participated in the clinical studies for these investigational candidates,” the Companies said. The randomized Phase IIb TARGET trial in non-small cell lung cancer (NSCLC) is ongoing. The Companies are awaiting maturation of the overall survival data later this year to help inform potential further development of the vintafolide and docetaxel combination in NSCLC.