Independent data monitoring committee determines that Phase III study of Prostvac in prostate cancer should not continue.- Bavarian Nordic.

Bavarian Nordic A/S announced that an independent Data Monitoring Committee (DMCB) has determined, based on a preplanned interim analysis, that continuation of the Phase III PROSPECT study of Prostvac vaccine in patients with metastatic castration-resistant prostate cancer (mCRPC) is futile.

PROSPECT was a global, randomized, double-blind, placebo-controlled Phase III study conducted under a Special Protocol Assessment (SPA) from the FDA. The objective of the study was to determine whether Prostvac alone or in combination with GM-CSF could prolong overall survival in men with asymptomatic or minimally symptomatic mCRPC. The study enrolled 1,297 patients at more than 200 sites in 15 countries.