Positive data for Glivec in early GIST study

22 April 2007

Swiss drug major Novartis says that the interim analysis of data from a study of its anticancer agent Glivec (imatinib) indicate that the agent dramatically reduces the likelihood of disease recurrence following surgery for the removal of Kit-positive gastrointestinal stromal tumors. The study, which was sponsored by the National Cancer Institute, was designed to compare the efficacy of a 400mg daily dose of Glivec, versus placebo, in patients who have had surgery for Kit-positive GIST tumors. In total, 600 subjects were randomized into either treatment or placebo groups for a one-year period, with subjects in the control arm eligible to receive the drug if they went on to experience disease recurrence.

97% Glivec patients disease free after a year

The interim analysis showed the 97% of the patients treated with Glivec were disease-free after one year, compared with 83% of those in the placebo cohort. The investigators made public the results which fulfiled the trial's primary endpoint, and have begun offering the drug to the placebo group.

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