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Format: 04/16/2014
Format: 04/16/2014


Reuters: Failed Avastin study detailed, other trials go on

Tuesday, June 2nd, 2009

A failed study of blockbuster drug Avastin in colon cancer patients who have undergone surgery was detailed for the first time on Saturday, but similar clinical trials are still ongoing.

The 2,710-patient trial, for which top-line results were announced in April, found that adding Avastin to standard
chemotherapy did not improve disease-free survival for patients with locally advanced colon cancer. After a median follow-up of three years, the investigators found that 77.4 percent of patients in the Avastin group were alive and free of disease, compared with 75.5 percent of patients in the control group, a difference that was not statistically significant.

The results were presented here at the annual meeting of the American Society of Clinical Oncology. Avastin, known chemically as bevacizumab, is an antibody designed to fight cancer by interfering with the blood supply to tumors. It is made by Genentech, which is now a unit of Switzerland's Roche Holding AG (ROG.VX).

The drug, which has annual sales of about $4.4 billion, is currently approved for treating metastatic colorectal, breast, lung and later-stage brain cancers. This was the first trial which sought to show Avastin's ability to prevent cancer recurrence by wiping out microscopic cancer cells that may remain in the body after tumors have been removed by surgery, known as use in the "adjuvant" setting.

But several similar trials are under way, including a second in early-stage colon cancer patients for which results are
expected next year.

"One interesting effect was that during the year that patients were receiving bevacizumab we saw a benefit in disease-free survival that subsequently diminished when follow-up was completed," Dr. Norman Wolmark, chairman of the Department of Human Oncology at Allegheny General Hospital and the study's lead author, said in a statement. He said the transient benefit illustrates that there is more to learn about how Avastin works, and more clinical trials are needed to determine how it can be used most effectively.

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