Merck Serono, a division of Merck KGaA, Darmstadt, Germany, announced today that patient enrollment in the global pivotal Phase III clinical study CENTRIC has been completed. CENTRIC was designed to assess the efficacy and safety of the investigational integrin inhibitor cilengitide in combination with standard treatment in a biomarker-defined subgroup of newly diagnosed patients with glioblastoma (GBM). More than 500 patients have been successfully recruited into this global trial. The primary endpoint of the study is overall survival.
"Completing patient enrollment in the CENTRIC study is a very exciting milestone for us and takes us a step closer to evaluating the efficacy and safety of cilengitide in patients with this aggressive form of brain cancer, an area of high unmet medical need," said Dr. Oliver Kisker, Senior Vice President for the Global Clinical Development Unit, Oncology at Merck Serono.
Developed in Merck Serono's own laboratories in scientific collaboration with external partners, cilengitide is the first in a new class of investigational anti-cancer therapies, known as integrin inhibitors, to reach Phase III development. Cilengitide is thought to control tumor growth by working in two ways: through attacking the tumor cells directly in a targeted manner and through starving tumor cells by stopping the formation of new blood vessels that feed the tumor. Cilengitide is an investigational agent and has not been approved for commercial distribution.
In Europe, two to three people in 100,000 develop glioblastoma each year. In the United States, about three new cases per 100,000 are reported anually. Though rare, glioblastoma is the most aggressive form of primary brain tumors and has a poor prognosis in adults with a two-year overall survival rate of 27.2% with standard of care treatment (radiotherapy plus temozolomide).
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