The FDA approval is the result of findings from a phase 3 EORTC 26101 study, which added Avastin to lomustine chemotherapy, resulting in a reduced risk of glioblastoma progression, or proving fatal, by 48 per cent.
“Glioblastoma is the most common and aggressive form of brain cancer and can be very difficult to treat,” said Sandra Horning MD, Chief Medical Officer and Head of Global Product Development at Genetech. “Delaying disease progression and reducing the need for corticosteroids over the course of treatment are considered important goals for those impacted by this devastating disease where patients have limited treatment options.”
The phase 3 EORTC 26101 study was conducted on 432 patients with recurrent glioblastoma. Patients were split into two groups. One took a combination of Avastin and lomustine, and the other just lomustine. The primary objective of the study was to determine if overall survival, progression-free survival (the length of time during and after treatment that a patient lives with the disease, but it doesn’t get worse) and overall response rate.
The study found no significant
change in overall survival with the addition of Avastin. However, adding
Avastin to lomustine resulted in an average progression-free survival of more
than four months, compared to 1.5 months with lomustine alone.
Half of all patients across both
categories were taking corticosteroids as a baseline supplement. Of these
patients, 23 per cent taking Avastin were able to stop corticosteroids while on
the treatment, compared to 12 per cent taking lomustine.
In May 2009 the FDA granted
accelerated approval for Avastin for use as a monotherapy (a single drug to
treat a particular disease) to treat patients with glioblastoma whose tumours progressed
following earlier therapy. This approval was based on two single-arm trials - NCI
06-C-0064E and AVF3708g.
In the AVF3708g trial, previous
glioblastoma patients received 10 mg/kg IV of Avastin fortnightly until the
disease progressed or reached an unacceptable level of toxicity. The FDA only
considered the single-agent arm for the accelerated approval. Of the 85
patients in this category, the overall response rate was 25.9 per cent, with
the average response duration being 4.2 months.
However, in the NCI 06-C-0064E
study, which involved 56 patients who were previously treated for gliomas, received
10mh/kg IV of Avastin fortnightly. Here the overall response rate was 19.6 per
cent, with the median duration of response being 3.9 months.
Safety data from the AVF3708g study
indicated the most common side-effects from Avastin were infection, fatigue,
hypertension, headache, diarrhea and epistaxis.
Avastin is currently not reimbursed
for GBM patients in Australia.
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