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news.Genentech said that both study arms of a Phase II study of Avastin administered alone or in combination with irinotecan chemotherapy demonstrated encouraging six-month progression-free survival and objective response rate in patients with relapsed glioblastoma multiforme, the most common and aggressive type of brain cancer.
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As assessed by independent radiological review, 36% of glioblastoma multiforme (GBM) patients treated with Avastin alone, and 51% of patients treated with Avastin in combination with chemotherapy, lived without the disease advancing within six months. In addition, preliminary estimates of tumor response were observed in 21% of patients treated with Avastin alone and in 34% of patients treated with Avastin in combination with chemotherapy.
The study was a Phase II, open-label, multicenter, randomized, non-comparative study that enrolled 167 patients with GBM whose cancer had relapsed after first- or second-line therapy. The primary endpoints were six-month progression-free survival (PFS) and objective response rate as determined by an independent radiology facility.
Secondary endpoints of the study included overall survival and safety. The study is ongoing and final analyses for safety and other efficacy endpoints will be available in 2008.