OncoMethylome Sciences has begun MGMT gene promoter methylation testing in a recently started phase-III clinical trial for the US-based, Radiotherapy Oncology Group (RTOG) in newly diagnosed brain tumours (glioblastoma [GBM]).
This trial will compare the current standard-of-care therapy, concurrent chemoradiation and adjuvant temozolomide (Temodar, Schering-Plough) with the standard-of-care and the addition of bevacizumab (Avastin, Genentech, a wholly-owned member of the Roche Group). All patients will receive standard therapy of radiation and daily temozolomide for three weeks. Patients will then be stratified by MGMT methylation status and molecular profile to receive standard therapy plus bevacizumab or a continuation of their standard therapy plus placebo. OncoMethylome Sciences will receive payments for performing MGMT testing using their patented Methylation-Specific PCR technology.
"Prior studies have shown that patients with methylated MGMT are more likely to respond to temozolomide-based therapy. Since encouraging response rates have been demonstrated in phase-II trials of Avastin for treatment in patients with recurrent glioblastoma, we designed this trial as a natural progression to evaluate the benefits of the combination therapy in newly diagnosed GBM," said Mark R Gilbert, MD, the study's principal investigator and professor of neuro-oncology at the University of Texas Maryland Anderson Cancer Center. "The goal of RTOG 0825 is to demonstrate improvements in progression-free and overall survival in all GBM patients being treated with the combination therapy versus temozolomide/radiation therapy alone."
Herman Spolders, CEO of OncoMethylome commented, "We are very pleased that the RTOG has determined that testing for MGMT gene methylation will play a key role in evaluating patient response to this combination therapy. This trial supports our efforts to establish the clinical value of MGMT methylation for optimizing the treatment decision-making process for patients with advanced brain tumours and confirms market interest in our MGMT assay leading to personalized and more effective treatments."
GBM is the most aggressive and malignant form of glioma, a type of primary brain tumour.
The use of OncoMethylome's MGMT assay is based on studies that have shown that methylation (silencing) of the MGMT gene promoter may help to identify brain tumors more likely to respond to standard chemotherapeutic agents.
Bevacizumab (Avastin) is a biologic antibody designed to specifically inhibit the vascular endothelial growth factor (VEGF) protein that plays an important role in the development and maintenance of blood vessels, a process known as angiogenesis.
OncoMethylome Sciences is a molecular diagnostics company developing gene methylation tests to assist physicians in effectively detecting and treating cancer.