- Clinical Trials
- Research News
- Industry Trends
- Agency Actions
- Drug Safety Issues
- Approvals, Launches, & New Indications
- Health Care Reform
Brain Cancer Drug Cilengitide Fails Phase III Trial
No improvement in survival when added to standard therapy (Feb. 25)
According to a recent announcement, a phase III study of the investigational integrin inhibitor cilengitide (Merck KGaA) did not meet its primary endpoint of significantly increasing overall survival when added to the current standard chemoradiotherapy regimen (temozolomide and radiotherapy). The ongoing study includes patients with newly diagnosed glioblastoma and methylated O(6)-methylguanine-DNA methyltransferase (MGMT) gene promoter status. Detailed trial results will be submitted for presentation at the 2013 annual meeting of the American Society of Clinical Oncology (ASCO).
In the U.S., cilengitide is being developed by EMD Serono, a Merck subsidiary.
The open-label CilENgitide in Combination With Temozolomide and Radiotherapy In Newly Diagnosed Glioblastoma Phase III Randomized Clinical Trial (CENTRIC) evaluated the efficacy and safety of cilengitide in combination with temozolomide and radiotherapy in more than 500 patients 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 a phase II study, the Cilengitide in Patients With Newly DiagnOsed Glioblastoma MultifoRme and Unmethylated MGMT GenE Promoter (CORE) trial.
Cilengitide is the first in a new class of investigational targeted anticancer therapies — integrin inhibitors — to reach phase III clinical development. The drug is thought to target certain integrins that are over-expressed or aberrantly expressed in many cancers. Integrins are involved in tumor cell growth and in the formation of new tumor-related blood vessels in the tumor microenvironment.
Source: Merck KGaA; February 25, 2013.