Merck: Phase III Trial of Cilengitide Did Not Meet Primary Endpoint in Patients With Newly Diagnosed Glioblastoma
Patients with newly diagnosed glioblastoma and methylated MGMT gene promoter status did not live significantly longer when treated with cilengitide plus chemoradiotherapy
Merck announced that the Phase III CENTRICa trial of the investigational integrin inhibitor Cilengitide did not meet its 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 Organisation for Research and Treatment of cancer (EORTC). Detailed trial results will be submitted for presentation at the American Society of Clinical Oncology (ASCO) 2013 Annual Meeting and publication in a peer-reviewed journal.
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.
“These results illustrate how challenging this disease remains, and that thorough clinical investigations like in this study are crucial before adopting new treatment strategies,” said the lead investigator and president of the EORTC Professor Roger Stupp, Head of Neuro-Oncology, Department of Neurosurgery, University of Lausanne Medical Center, Lausanne, Switzerland and newly appointed director of the Zurich University Cancer Center. “Nevertheless, the unique collaboration between academia and industry was key in establishing molecular tumor characterization towards personalized medicine. And it allows for investigation of mechanisms of disease, and identifying novel targets and combinations for the future. We remain committed to addressing the needs of patients suffering from this rare disease and will continue to investigate other treatment options.”
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