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Many More Patients Can Now Benefit from Avastin's Proven Survival Benefits
Date:1/27/2008

The approval of this broad label is based on the results of two large international phase III pivotal studies (NO16966 and E3200).

About the Phase III studies that formed the basis of the approval

Note: Progression-free survival is a measure of the time patients live without their disease advancing.

NO16966 study

NO16966 is a large, international phase III trial which recruited 2,034 patients. It was originally planned to compare XELOX vs FOLFOX as first-line treatment in metastatic colorectal cancer. After release of the pivotal Avastin data in colorectal cancer in 2003, the protocol was amended to investigate using a 2 by 2 factorial design: FOLFOX/XELOX + placebo vs FOLFOX/XELOX + Avastin.

The primary objective was to answer two questions: 1) whether the XELOX regimen is non-inferior to FOLFOX; 2) whether the addition of Avastin to chemotherapy improved progression-free survival compared to chemotherapy alone. The secondary endpoints included overall survival, overall response rates, time to, and duration of, response and safety profile. Results of the study showed:

-- The addition of Avastin to chemotherapy (XELOX or FOLFOX-4) significantly improved progression-free survival by 20% compared with chemotherapy alone.

-- In patients that received treatment until disease progression, the benefit was even greater, and adding Avastin to chemotherapy improved progression-free survival by 58%.

-- The chemotherapy combination XELOX is as effective in terms of progression-free survival as FOLFOX.

E3200 study

The E3200 study is a randomized, controlled, multi-center phase III trial of 829 patients with advanced or metastatic colorectal cancer who had received previous treatment with irinotecan and 5-FU as initial therapy for metastatic disease or as adjuvant therapy. The study showed that patients who received Avastin plus the 5-FU-based chemotherapy regimen known as FOLFOX4 (oxaliplatin/5-FU/leuc
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SOURCE Roche
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