Avastin Study Misses Endpoint In Early-Stage Colon Cancer

Genentech’s Phase III study of Avastin (bevacizumab) plus chemotherapy in patients with early-stage colon cancer (NSABP C-08) did not meet its primary endpoint of reducing the risk of cancer returning (improvement in disease-free survival). This is the first trial of Avastin in early-stage cancer and results do not affect approved indications in advanced (metastatic) disease.

“While we are disappointed the C-08 study did not meet its primary endpoint, our initial review of the data leads us to continue to believe Avastin may be active in patients with early-stage colon cancer and look forward to NSABP’s presentation at ASCO,” said Hal Barron, M.D., senior vice president, development and chief medical officer, Genentech. “We remain fully committed to the ongoing Avastin adjuvant programs in early-stage colon, breast and lung cancers.”

“In order to provide patients with the full potential benefit of Avastin in early-stage cancer, we believe the findings of the C-08 trial should be considered for the ongoing adjuvant trial programs,” said William M. Burns, chief executive officer of Roche’s Pharmaceutical Division. “The current studies and indications in advanced disease are not affected.”