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Merck at ASCO 2007: Encouraging Results in Progression-Free,Survival in Patients With Aggressive Brain Tumors (glioblastoma),Using Cilengitide in Phase I/IIa Study

Phase III trial planned
Abstracts: 2000, 2002

CHICAGO/DARMSTADT, Germany, June 4, 2007 – Results of a Phase I/IIa study presented today at the American Society of Clinical Oncology (ASCO) annual meeting in Chicago demonstrate the clinical activity of cilengitide in patients with newly diagnosed glioblastoma – a particularly aggressive form of brain tumor. Cilengitide is a highly selective integrin inhibitor targeting the tumor and its vasculature.

Fifty-two patients with newly diagnosed glioblastoma were treated with cilengitide, combined with a standard regimen of radiotherapy and temozolomide following tumor resection or biopsy. The study reached the predefined primary endpoint with 69% of patients being alive and progression free at six months, and showed a median progression free survival (PFS) of 8.1 months. In a defined patient subgroup with the methylated MGMT gene promoter in the tumor tissue, 91% of patients had six months PFS and the median has not yet been reached. These results are encouraging when compared to the historical control of the EORTC-NCIC phase III trial [overall population: 54% 6 months PFS, median PFS of 6.9 months;(1) methylated MGMT gene promoter subgroup: 69% PFS and 10.3 months median PFS].(2)

Lead investigator Dr. Roger Stupp of the University of Lausanne Hospital in Switzerland, commented: “We are excited by these findings. They demonstrate the potential of cilengitide to make a real difference to the outcome of patients with this aggressive type of brain cancer, where currently available treatment options are limited and prognosis is poor. We look forward to learning more about the benefits of this promising agent in larger patient populations.”

Also presented at ASCO was a Phase IIa randomized multicenter trial, examining two dosing levels of cilengitide monotherapy (500mg and 2000mg) in 81 patients with recurrent gliobl
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