Merck KGaA readies phase III brain cancer trial
pharmafile | June 13, 2011 | News story | Research and Development | Merck KGaA, brain cancer, cilengitide, glioblastoma
Merck KGaA has completed patient enrollment for a phase III global trial of its first-in-class integrin inhibitor in a rare but aggressive form of brain cancer.
The CENTRIC trial will examine investigational drug cilengitide in combination with standard therapy – radiotherapy plus temozolomide – as a first-line treatment for glioblastoma (GBM) sufferers.
Integrin inhibitors are thought to control tumour growth by attacking tumour cells directly and by preventing the formation of new blood vessels that feed the tumour.
Developed in Merck Serono’s labs, cilengitide is the first such drug to reach phase III and the primary endpoint of the trial is overall survival.
In Europe, two to three people in 100,000 develop the disease each year but there is a poor prognosis in adults, with a two-year overall survival rate of 27.2% with standard of care treatment.
“Completing patient enrollment in the CENTRIC study is a very exciting milestone for us,” said Oliver Kisker, senior vice president for Merck Serono’s Global Clinical Development Unit, Oncology.
“[The trial] takes us a step closer to evaluating the efficacy and safety of cilengitide in patients with this aggressive form of brain cancer, an area of high unmet medical need,” he added.
A biomarker-defined subgroup of more than 500 newly-diagnosed GBM patients is to take part in CENTRIC. Meanwhile a phase I/II companion trial, CORE, is investigating cilengitide in patients with an unmethylated MGMT gene promoter in the tumour tissue.
There are also phase I/II trials in non-small cell lung cancer (CERTO) and squamous cell carcinoma of the head and neck (ADVANTAGE).
US biotech company Celldex is to begin an international, placebo-controlled phase III trial of its own anti-GBM drug later in the year.
It says studies of rindopepimut (CDX-110) in newly-diagnosed GBM patients show a significant extension in progression free survival.
Unlike cilengitide, rindopepimut is an immunotherapeutic vaccine that targets epidermal growth factor receptor variant III (EGFRvIII).
The company’s data showed 66% of patients were progression-free at 8.5 months from diagnosis or 5.5 months from start of vaccination, a statistically significant increase over a predetermined progression-free rate (PFR) estimate of 53%.
This compares to studies of patients on standard of care which showed between 29% and 45% of patients progression-free at 8.5 months post-diagnosis.
Adam Hill
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