Roche released full details from a Phase III study of Avastin (bevacizumab) showing that the drug failed to improve disease-free survival (DFS), compared with chemotherapy, in patients with early-stage colon cancer. The presentation of the data at ASCO follows Roche’s announcement in April that the trial did not meet its primary endpoint.

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The C-08 study involved 2710 patients with surgically-resected stage II or III adenocarcinoma of the colon who received either six months of treatment with chemotherapy alone, or six months of treatment with chemotherapy plus Avastin followed by six months of Avastin monotherapy. After a follow up of three years, findings demonstrated that 77.4 percent of patients in the Avastin arm were free of disease, compared with 75.5 percent of those in the control group. The result was not statistically significant, but lead investigator Norman Wolmark noted that Avastin reduced the risk of cancer recurrence or death by about 40 percent at the one-year mark.

Philippe Bishop, head of clinical development at Roche’s Genentech unit, explained that “as patients come off treatment, the events come back…The one-year duration of treatment was insufficient to derive clinical benefit.” Wolmark stated that “these results suggest longer durations of Avastin treatment should be considered for future studies in early-stage colon cancer to further reduce the risk of the cancer coming back,” and he added that researchers hope to begin a trial in the near future using Avastin for a two-year treatment period.

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A separate late-stage study of Avastin in the adjuvant setting in early-stage colon cancer is in progress, with results expected next year. Bishop indicated that the results from the C-08 study are influencing Roche’s and Genentech’s ongoing clinical trial programme for the drug, which includes use in early-stage breast cancer and non-small-cell lung cancer.

Source: FirstWord

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