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Positive Results From Avastin Plus FOLFOX4 Chemotherapy Trial Presented

January 28, 2005

Genentech has announced that a randomized Phase III study (E3200) of Avastin plus the FOLFOX4 chemotherapy regimen, compared to FOLFOX4 alone in second-line metastatic colorectal cancer patients achieved its primary endpoint of improving overall survival.

Avastin (bevacizumab) is currently approved as a first-line treatment for metastatic colorectal cancer in combination with intravenous 5-FU-based chemotherapy. Results from a preliminary analysis of the E3200 study demonstrated that patients receiving Avastin plus FOLFOX4 (oxaliplatin/5-FU/leucovorin) had a 26 percent reduction in the risk of death, the primary endpoint, compared to patients who received FOLFOX4 alone.

Median survival for patients receiving Avastin plus FOLFOX4 was 12.5 months, compared to 10.7 months for those receiving FOLFOX4 alone, a 17 percent improvement. Adverse events in this Phase III study were consistent with those seen in previous Avastin and FOLFOX4 clinical trials in metastatic colorectal cancer. The most frequent adverse events were hypertension and sensory neuropathy.