Genentech: Recruitment suspended in Avastin phase 3 cancer trial amid safety concerns

By E. Janene Geiss

Philadelphia, Feb. 13 - Genentech, Inc. announced Monday that enrollment into Avant, an international phase 3 study of Avastin (bevacizumab), Xelox and Folfox chemotherapy regimens in early stage colon cancer has been temporarily suspended to enable the Data Safety Monitoring Board to conduct a review of 60-day safety data.

The board's recommendations are based on adverse events observed at a higher rate in the Xelox/Avastin arm of the study compared to the other two arms of the study (Folfox and Folfox/Avastin), according to a company news release.

Officials also said the rapid recruitment in the Avant trial of more than 200 patients per month could prevent an adequate and timely safety assessment.

The Xelox regimen consists of capecitabine and oxaliplatin, and the Folfox regimen consists of oxaliplatin, 5-FU and leucovorin, officials said.

Excluding deaths due to recurrent colon cancer, all-cause mortality was 0.6%, or four cases, for Folfox, 0.4%, or three cases, for Folfox/Avastin and 1%, or seven cases, for Xelox/Avastin.

Two cases of cardiac and unknown deaths, some of which occurred in younger patients, were noted in the Xelox/Avastin arm, officials said.

Since the Avant trial began recruitment in December 2004, nearly two-thirds of the target number of 3,450 patients has been enrolled, and in January 2006 alone more than 250 patients were recruited, officials said.

The safety board will continue to monitor all adverse events in the study, including gastrointestinal perforations, an adverse event observed in previous studies of Avastin plus chemotherapy that has been observed in Avastin-treated patients in the Avant study at a rate of about 1%, officials said. This is less than what has been observed in the metastatic setting.

"Due to the rapid enrollment of patients in the Avant study and the ongoing need to carefully monitor safety, we believe that the [the board's] recommendation to temporarily suspend enrollment in the study is the right thing to do for patients in order to enable a more detailed analysis of safety data," Hal Barron, Genentech's senior vice president of development and chief medical officer, said in the release.

Avant is an international study being conducted by Roche to evaluate whether the addition of Avastin to chemotherapy as an adjuvant treatment following surgery can reduce the chance of recurrence in patients with stage 2 and 3 colorectal cancer.

Genentech is a South San Francisco biotechnology company focused on developing new ways to treat cancer.

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