Merck Serono reports long-term follow-up data of cilengitide Phase II study for recurrent glioblastoma

ASCO Abstract Numbers: 2010, TPS151, TPS152

“These positive long-term data once again support our ongoing Phase III study program of cilengitide in patients with this devastating disease. We believe that cilengitide may play a valuable part in the future care of glioblastoma patients”

Merck Serono, a division of Merck KGaA, Darmstadt, Germany announced today that long-term follow-up data of a randomized Phase II study of two cilengitide doses in recurrent glioblastoma were presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. The data showed that treatment of 15 patients with the investigational integrin-inhibitor for more than six months and for up to 4.5 years did not result in any treatment-related severe adverse events (Grade 3/4). In addition, 37% of patients who received the higher dose of cilengitide (2000 mg) were still alive after one year and 22% after two years. The current prognosis of patients with recurrent glioblastoma is poor with median overall survival (OS) between 4-7 months and one year survival rates of approximately 20%.

Treatment-related adverse events (AEs) usually occurred within the first six months of receiving cilengitide and the most common (>1 patient) was fatigue.

"The prognosis for patients with recurrent glioblastoma is extremely poor and additional treatment options have been desperately needed for some time," said Dr. Karen Fink, Baylor University Medical Center, Dallas. "We are excited about the results of this study, in that patients were able to receive cilengitide beyond six months with no treatment-related severe adverse events. Moreover, 10% of patients were still alive after four years."