Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the Phase III AVAglio study of Avastin
(bevacizumab) plus radiation and temozolomide chemotherapy in people with newly diagnosed glioblastoma met its co-primary endpoint of a significant improvement in progression-free survival (PFS). In the study, Avastin in combination with radiation and temozolomide chemotherapy significantly extended the time people with this aggressive form of primary brain cancer lived without their disease getting worse (PFS), compared to those treated with radiation and temozolomide chemotherapy plus placebo. Data for final overall survival (OS), the other co-primary endpoint, are expected in 2013.
No new safety findings were observed in the AVAglio study, and adverse events were consistent with those seen in previous trials of Avastin across tumor types for approved indications. Full data from the AVAglio study will be submitted for presentation at an upcoming medical meeting.
Avastin is currently approved in the United States for the treatment of adults with glioblastoma who have progressive disease following prior therapy. In glioblastoma, it is approved for use as a single therapy and not in combination with other therapies. The effectiveness of Avastin is based on improvement in objective response rate. Currently, no data are available from randomized controlled trials demonstrating improvement in disease related symptoms or increased survival with Avastin in glioblastoma. The approval was granted under the U.S. Food and Drug Administration’s (FDA) accelerated approval program.
“This study showed that people with glioblastoma, a particularly devastating and aggressive cancer without many treatment options, lived significantly longer without their disease worsening when Avastin was added to radiation and temozolomide chemotherapy,” said Hal Barron, M.D., chief medical officer and head, Global Product Development.
Roche and Genentech plan to discuss these Phase III results with global regulatory authorities, including the European Medicines Agency (EMA) and FDA.