Roche suspends Avastin AVANT study

Swiss drug major Roche says that it has suspended recruitment in a Phase III trial of the cancer drug Avastin (bevacizumab), used in the treatment of colorectal cancer, due to safety concerns relating to several sudden deaths in patients prescribed Xelox (capecitabine plus oxaliplatin) and Avastin in cohort C of the firm's ongoing AVANT study. The company says that the suspension will allow the independent Data Safety Monitoring Board to review the 60-day safety data that the firm has already collected, and added that patients already enrolled in the program will continue taking the medication as per the protocol.

Principle investgator Aimery de Gramont, said that the trial provides a unique opportunity to assess the combination of chemotherapy and anti-angiogenic agents. Prof de Gramont added that : "the temporary halting of the recruitment is necessary because in the adjuvant setting, the threshold for concern is particularly low."

A second study of Avastin as an adjuvant to chemotherapy for the treatment of early-stage colon cancer is continuing as planned under the leadership of the US National Surgical Breast and Bowel project. The group says that this second trial will enroll 2,714 patients who will be randomized to receive either Folfox4 chemotherapy (oxaliplatin, 5 fluorouracil and leucovovin) or Folfox and Avastin combined therapy. Avastin first gained US Food and Drug Administration approval in February 2004 having gained fast-track designation.