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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

astoma. Following surgery or biopsy, more than 98% of these patients had previously been treated with radiotherapy and temozolomide and had relapsed on these treatments. The PFS rate was 16% and 10% at six and 12 months, respectively. While the target of 25% of patients being progression free at six months was not met, there was a subset of patients with very clear and prolonged clinical response, which indicated biological activity. Durable significant responses have been observed with stabilization so far for up to two years. The observed median overall survival was 6.5 months with the low dose and 9.9 months with the high dose of cilengitide. These results are encouraging considering the limited treatment options for recurrent glioblastoma patients.

“These results of cilengitide in glioblastoma – a very difficult to treat tumor – are important. New highly active, well-tolerated targeted therapies inducing significant responses are strongly needed. Based on these results, we are planning a Phase III trial to investigate the benefits of cilengitide in glioblastoma in a larger confirmatory trial,” said Dr. Wolfgang Wein, Senior Executive Vice President, Oncology, Merck Serono – a division of Merck KGaA, Darmstadt, Germany.

“Cilengitide is part of the Merck Serono Oncology portfolio – led by the epidermal growth factor receptor-targeting monoclonal antibody Erbitux® – and the clinical programs for these investigational products demonstrate Merck Serono’s commitment to developing new treatment options for patients with cancer,” Dr. Wein stated.

There are 189,000 new cases of cancers of the brain and nervous system globally each year, and 142,000 deaths. This accounts for 1.7% of new cancers and 2.1% of cancer deaths.(3) Brain tumors account for as many as 90% of all primary central nervous system tumors.(4) The commonest type of primary brain tumor is glioma, accounting for 80% of all
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