Merck KGaA's cilengitide fails to meet main goal of late-stage brain cancer study

Merck KGaA's Serono unit announced Monday that a Phase III trial of the experimental integrin inhibitor cilengitide failed to meet the primary endpoint of significantly increasing overall survival in certain patients with newly diagnosed glioblastoma. "The results of CENTRIC are disappointing," remarked Annalisa Jenkins, head of global drug development and medical at the company, adding "we remain committed to advancing our pipeline and developing new treatment options in oncology."

The trial randomised more than 500 patients with newly diagnosed glioblastoma and methylated MGMT gene promoter status to receive standard chemoradiotherapy either alone or in combination with cilengitide. Merck noted that data from the study will be presented at the ASCO meeting and published in a peer-reviewed journal.

Cilengitide is also being investigated in the Phase II CORE trial in patients with newly diagnosed glioblastoma and unmethylated MGMT gene promoter status. In addition, a Phase I/II study in patients with non-small-cell lung cancer (NSCLC) is ongoing.

Helvea analyst Odile Rundquist said the result is "another blow" for the Serono unit, following the failure of Stimuvax, also known as L-BLP25, to improve overall survival in patients with NSCLC in a late-stage trial last year.

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