Roche announced that an analysis of the phase-II BRAIN study of Avastin (bevacizumab) alone or in combination with irinotecan chemotherapy for the treatment of relapsed or progressive glioblastoma (GBM) demonstrated that in addition to increasing the chance of patients being alive without worsening of their disease at six months (progression free survival; PFS-6), Avastin-based therapy may also lead to additional positive impact on patients' daily lives. Adverse events in the BRAIN study were consistent with those previously seen with Avastin and no new safety signals were reported.
The analysis presented today at Europe's largest scientific meeting for cancer specialists, the joint 15th ECCO and 34th ESMO, showed that those patients who responded to Avastin-based therapy may also have a stabilisation or improvement in neurocognitive function and a reduction in their dose of steroids2).
"Stabilising neurocognitive function and reducing reliance on steroids can improve day to day life for patients with recurrent GBM which, given the poor prognosis, is a key aim of treatment," said professor James Vredenburgh, medical director, Adult Clinical Service, Duke University Medical Center, Durham, USA. "This analysis suggests that Avastin-based therapy which has already demonstrated PFS benefits may also have a positive impact on patients' daily lives and should offer hope to physicians, patients and their caregivers alike."
Neurocognitive function includes the ability to think and reason, to make judgements and remember things. A decline in this function, a common consequence of GBM, can be distressing for both patients and their families. Avastin based treatment was also associated with lower use of steroids in some patients. Steroids are an important part of managing symptoms in many patients with GBM but they can lead to complications such as weight gain, insomnia and behavioural changes. Reduction in steroid dose means that physicians may be able to reduce the side effects of long term steroid use.
GBM is the most common and the most aggressive type of primary malignant brain tumour and most patients experience relapse or progression of their disease following initial treatment3,4). When the disease returns, prognosis is particularly poor and improving day to day life for patients is a component of the treatment aim.
"Avastin continues to demonstrate its benefits as a treatment for an increasing variety of cancers," said William M Burns, CEO of Roche's Pharmaceuticals Division. "Avastin based therapy has the potential to make a real difference for patients with glioblastoma."
Avastin precisely inhibits vascular endothelial growth factor (VEGF) a key mediator of angiogenesis, the growth of new blood vessels, which is essential for tumour growth and spread. GBM has very high VEGF expression. By controlling angiogenesis, Avastin controls tumour growth.
In May 2009, Avastin was granted accelerated approval for the treatment of GBM patients with progressive disease following prior therapy from the US Food and Drug Administration (FDA) based on data from the BRAIN study (AVF3708g) which was recently published in the Journal of Clinical Oncology1) and an NCI study (NCI 06-C-0064E). The data is currently being discussed with regulators in Europe and has led to approvals in Switzerland, Albania, Dominican Republic, India, Moldova and the Ukraine.
Avastin is an antibody that specifically binds and blocks the biological effects of VEGF (vascular endothelial growth factor).