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Novartis Drug Gleevec® Shows Significant Overall Survival Benefit for Patients With GIST After Three Years of Adjuvant Treatment vs. One Year
Date:6/5/2011

EAST HANOVER, N.J., June 5, 2011 /PRNewswire/ -- Novartis announced new data today showing a significant improvement in both recurrence-free survival and overall survival for patients taking Gleevec® (imatinib mesylate)* tablets for three years after surgery to remove KIT (CD117)-positive gastrointestinal stromal tumors (KIT+ GIST) compared to one year of treatment. These data will be presented at the 47th American Society of Clinical Oncology (ASCO) plenary session on Sunday, June 5.

The results show that at five years 66% of patients taking Gleevec for three years remained free of cancer recurrence (primary endpoint) compared to 48% who had received Gleevec for only one year (p<0.0001). Moreover, 92% of patients taking Gleevec for three years were alive (secondary endpoint) compared to 82% who had received Gleevec for only one year (p=0.019) (1). Median patient follow-up was 54 months.

The 400-patient Phase III trial, conducted by the Scandinavian Sarcoma Group (SSG) and the Sarcoma Group of the Arbeitsgemeinschaft Internistische Onkologie (AIO), is the first prospective multicenter clinical trial to demonstrate a survival benefit of adjuvant Gleevec therapy for KIT+ GIST with extended three years of therapy relative to one year of therapy. The side effect profile in the clinical trial was consistent with that reported in previous studies with Gleevec.

"This study confirms the hypothesis that extending the duration of Gleevec treatment for patients following surgery improves recurrence-free survival. For the first time, an effect on overall survival was found," said Heikki Joensuu, M.D., Ph.D., Professor, Oncology, University of Helsinki and principal investigator of the study. "Results from this trial may positively impact clinical practice by helping physicians create the optimal treatment plan for patients with operable KIT+ GIST."

Gastrointestinal stromal tumors are a rare, life-threatening cancer of the gastrointestinal
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