Swiss drug major Roche reveals 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 the compound and no new safety signals were reported.
Commenting on the news, Switzerland-based Helvea analyst Karl-Heinz Koch suggested that the use of Avastin for malignant melanoma, if approved, could be worth $1 billion or more, but "to realize that potential, Roche will likely have to run a confirmatory Phase III study" with similar results. In its current uses, the drug already generates annual revenues of some $4.8 billion for the drugmaker.
The analysis, presented at the joint 15th Congress of the European CanCer Organization (ECCO) and 34th Congress of the European Society for Medical Oncology (ESMO) held in Berlin, Germany, showed that those patients who responded to Avastin-based therapy may also have a stabilization or improvement in neurocognitive function and a reduction in their dose of steroids.
'Stabilizing 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 James Vredenburgh, medical director, adult clinical service at the 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,' Prof Vredenburgh added.
GBM is the most common and the most aggressive type of primary malignant brain tumor and most patients experience relapse or progression of their disease following initial treatment). 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 Burns, chief executive of Roche's Pharmaceuticals Division, adding: 'Avastin based therapy has the potential to make a real difference for patients with glioblastoma.'
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