Merck KGaA's EMD Serono, Inc Phase III Trial Of Cilengitide Did Not Meet Primary Endpoint In Patients With Newly Diagnosed Glioblastoma

EMD Serono, Inc., a subsidiary of Merck KGaA, Darmstadt, Germany, announced that the Phase III CENTRICa trial of the investigational integrin inhibitor cilengitide did not meet primary endpoint of significantly increasing overall survival when added to the current standard chemoradiotherapy regimen (temozolomide and radiotherapy). CENTRIC includes patients with newly diagnosed glioblastoma and methylated O6-methylguanine-DNA methyltransferase (MGMT) gene promoter status. The trial was planned and is being conducted in partnership with the European Organization for Research and Treatment of Cancer (EORTC). Patient safety in CENTRIC was monitored frequently by an independent data monitoring committee and no new or unexpected safety concerns were noted. In prior clinical studies, the most frequently reported adverse events the investigators considered to be attributed to cilengitide included nausea and fatigue. CENTRIC is a randomized, controlled, multicenter, open-label Phase III trial. The trial evaluated the efficacy and safety of cilengitide in combination with temozolomide and radiotherapy in more than 500 patients from 23 countries worldwide with newly diagnosed glioblastoma and methylated MGMT gene promoter status. Patients whose tumors have an unmethylated MGMT gene promoter status are currently being evaluated in the Phase II, randomized, open-label, multicenter COREb trial.