Vynfinit vintafolide: Phase III halted
Merck and Endocyte suspended the double-blind, placebo-controlled, international Phase III PROCEED trial evaluating Vynfinit in combination with doxorubicin to treat folate receptor-positive platinum-resistant ovarian cancer after an independent DSMB recommended the trial be stopped early for futility. The recommendation was based on a pre-specified interim futility analysis showing that Vynfinit plus doxorubicin "did not demonstrate efficacy" on the primary endpoint of PFS. The DSMB did not identify any safety concerns. The trial planned to enroll about 640 patients.
On a conference call to discuss the data and its 1Q14 financial results, Endocyte said PFS in the Vynfinit arm was consistent with that reported in the Phase II PRECEDENT trial in the indication, but that the placebo arm in PROCEED had a higher PFS than in PRECEDENT. In 2011, Endocyte reported data from PRECEDENT showing that Vynfinit plus doxorubicin led to a median PFS of 4.2 months vs. 2 months for doxorubicin alone (p=0.2235) (see BioCentury, Dec. 19, 2011). Endocyte said it is reviewing and validating the data with Merck to make a formal decision regarding the execution of PROCEED, but declined to disclose a time frame for when it expects to make a decision and report detailed data. ...