Phase III Cilengtide trial fails to meet primary endpoint

EMD Sereno has announced that its Phase III CENTRIC trial of the investigational integrin inhibitor cilengitude did not meet its primary endpoint.

The aim was for the drug to increase overall survival when added to the existing standard chermoradiotherapy regimen of temozolomide and radiotherapy.

CENTIRC features patients with newly diagnosed giloblastoma and methylated O6-methylguanine-DNA methyltransferase (MGMT) gene promoter status.

The trial was conducted in partnership with the European Organisation for Research and Treatment of Cancer (EORTC).

In-depth trial results will be submitted for presentation at the American Society of Clinical Oncology 2013 Annual Meeting, before being published in a peer-reviewed journal.

There were no unexpected safety concerns noted in the research, despite nausea and fatigue being seen in previous studies.

The CENTRIC trial evaluated the efficacy and safety of cilengtide in combination with termozolomide and radiotherapy in over 500 patients from a total of 23 countries.

Patients with tumours that have an unmethylated MGMT gene promoter status are presently being evaluated in the Phase II, randomized, open-label multicentre COREb trial.

Lead investigator and president of the EORTC Professor Roger Stupp said: "These results illustrate how challenging this disease remains, and that thorough clinical investigations like in this study are crucial before adopting new treatment strategies.

"Nevertheless, the unique collaboration between academia and industry was key in establishing molecular tumor characterization towards personalized medicine. And it allows for investigation of mechanisms of disease, and identifying novel targets and combinations for the future.

"We remain committed to addressing the needs of patients suffering from this rare disease and will continue to investigate other treatment options."

Dr Annalisa Jenkins, head of global drug development and medical for Merck Serono, also commented on the research, describing the results as "disappointing".

Ms Jenkins explained that the company remains committed to advancing its pipeline.

Posted by Fiona Griffiths