Merck withdraws vintafolide MAA
Merck & Co. Inc. (NYSE:MRK) withdrew an MAA from EMA seeking conditional approval of Vynfinit vintafolide to treat ovarian cancer. The pharma and partner Endocyte Inc. (NASDAQ:ECYT) made the decision based on further review of interim data from the Phase III PROCEED trial, which was suspended earlier this month after an independent DSMB recommended stopping the trial early for futility. The trial was evaluating Vynfinit in combination with doxorubicin to treat folate receptor-positive platinum-resistant ovarian cancer. Merck also withdrew MAAs seeking conditional approval of two companion imaging diagnostics for Vynfinit. EMA's CHMP had issued a positive opinion in March recommending conditional approval for all three (see BioCentury Extra, May 2).
This year, the partners expect overall survival (OS) data from the Phase IIb TARGET trial of Vynfinit plus docetaxel as second-line treatment of non-small cell lung cancer (NSCLC). Merck has exclusive, worldwide rights from Endocyte to Vynfinit, which is folate linked to an alkaloid chemotherapy agent. ...