Merck & Co., Endocyte Withdraw EU Application for Vintafolide

Merck & Co. Inc. and the biopharmaceutical company Endocyte, Inc. have withdrawn the conditional marketing authorization applications (CMA) from the European Medicines Agency for vintafolide and companion imaging components, imaging agent etarfolatide and intravenous 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 clinical trials that showed 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. Earlier this month, Merck and Endocyte suspended a Phase III trial for vintafolide in combination with PLD for the treatment of folate receptor-positive, platinum-resistant ovarian cancer. The Phase II2b clinical trial for testing the combination of vintafolide and docetaxel in non-small cell lung cancer is ongoing.

Endocyte is developing small-molecule drug conjugates and companion imaging agents for personalized therapy. In 2012, Merck and Endocyte signed a drug-development pact for vintafolide under which Endocyte received a $120-million upfront payment and was eligible for milestone payments of up to $880 million based on the successful achievement of development, regulatory and commercialization goals for vintafolide for a total of six cancer indications.

Source: Merck & Co.

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