Merck KGaA has suffered a setback following disappointing late-stage data on its brain cancer drug cilengitide.
In a Phase III trial called Centric, cilengitide, which is an integrin inhibitor, did not meet its primary endpoint of significantly increasing overall survival when added to the current standard chemoradiotherapy regimen, ie temozolomide and radiotherapy. The study included some 500 patients with newly-diagnosed glioblastoma and methylated O6-methylguanine-DNA methyltransferase (MGMT) gene promoter status; detailed results will be submitted for presentation at the American Society of Clinical Oncology meeting in June.
Annalisa Jenkins, head of global drug development and medical for the Merck Serono division, said the Centric results "are disappointing, especially for people who are fighting this devastating and difficult-to-treat cancer". She added that over the coming months, the firm will analyse the data "and ensure appropriate public disclosure of key information that will serve future scientific research related to targeted therapies in oncology".
Dr Jenkins noted that "for a complete picture, we will also evaluate the results of the currently ongoing Phase II (Core) trial, which included only patients with an unmethylated MGMT gene promoter status".