Genentech Halts Enrollment In Avastin Early-Stage Colon Cancer Trial
This article was originally published in The Pink Sheet Daily
Executive Summary
The firm reports a higher rate of non-colon cancer related deaths in the AVANT trial for adjuvant use of bevacizumab.
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A two-arm study evaluating Avastin (bevacizumab) as an adjuvant treatment for early-stage colon cancer will continue despite Genentech's decision to suspend enrollment of its larger, three-arm AVANT trial for the same indication. The AVANT trial compares bevacizumab plus the chemotherapy regimen FOLFOX, FOLFOX alone, and bevacizumab plus the chemotherapy regimen XELOX. Genentech suspended enrollment in the study due to a higher rate of adverse events observed in the XELOX/Avastin arm, the company said Feb. 13. Seven non-colon cancer related deaths were observed in the XELOX/Avastin (1%) arm compared to four in the FOLFOX arm (0.6%) and three in the FOLFOX/Avastin arm (0.4%). The 1% mortality rate for XELOX/Avastin is less than what has been observed in the metastatic setting, estimated at up to 2%, Genentech noted. The study has enrolled almost two-thirds of its 3,450-patient target, Genentech said. Patients already participating in the study will continue to be treated. A two-arm study led by the National Surgical Breast and Bowel Project and the National Cancer Institute - comparing treatment with FOLFOX/Avastin to FOLFOX alone for early-stage colon cancer - will continue enrolling patients. The C-08 study has enrolled more than half of its 2,714-patient target. Avastin was approved for first-line treatment of metastatic colon cancer in combination with FOLFOX4 in February 2004. Genentech submitted an sBLA for Avastin for a relapsed metastatic colorectal cancer indication in December, giving it an estimated user fee date of Oct. 19 (1 (Also see "Genentech Files Avastin sBLA For Relapsed Metastatic Colorectal Cancer" - Pink Sheet, 19 Dec, 2005.)). The company also plans to file applications for Avastin as first-line treatment of metastatic breast cancer and first-line treatment of non-squamous non-small cell lung cancer in the first half of 2006. -Brian Marson |