National Brain Tumor Society comments on the recently announced results of the AVAglio and RTOG clinical trials.
Beginning in May of 2009, drug maker Genentech received accelerated approval from the U.S. Food and Drug Administration (FDA) to market Avastin (bevacizumab) for the treatment of recurrent glioblastoma multiforme (GBM). National Brain Tumor Society has since followed the progress of Genentech’s required post-market study of Avastin called AVAglio, and has also sought input from the brain tumor community about the role Avastin has played as one of only four approved brain cancer drugs.
National Brain Tumor Society is deeply disappointed in the recently announced results of the AVAglio clinical trial. This trial revealed that Avastin (in combination with standard of care treatments) did not significantly prolong the lives of newly diagnosed GBM patients.
We are equally concerned with additional findings from a large, National Cancer Institute (NCI)-supported clinical trial conducted by the Radiation Therapy Oncology Group (RTOG). Similar to the AVAglio trial, the RTOG study did not show statistically significant increases in overall survival for newly diagnosed GBM patients taking Avastin in combination with standard of care treatments. Data from the AVAglio and RTOG studies collectively have provided mixed results on issues such as progression-free survival (i.e. a measure of tumor growth in response to a therapy) and quality of life, which will require careful and further analysis to better understand their full meaning in terms of patient care.
While we had hoped to see positive overall survival figures, the gold standard of measurement for oncology drugs, further analysis of the recently concluded trials, as well as an anticipated FDA reaction, will necessitate larger discussions about Avastin’s role as a brain cancer treatment. Most important for patients, Avastin is still approved as a treatment for recurrent GBM.
The discouraging results from the AVAglio and RTOG studies underscore the critical importance of advancing research for the discovery of new, more durable therapies, while advocating for the continued availability of all treatment options for brain tumor patients.
Going forward, the National Brain Tumor Society will work with our medical and scientific advisors to bring clarity to the issue of how Avastin and other targeted therapies fit into the current glioblastoma treatment standard. Additionally, we are steadfastly determined to support the development of new therapeutic approaches through our integrated research and public policy programs.
For more information, please refer to our Avastin FAQ document.