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Published on 6 June 2011

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Novartis drug shows survival benefit for patients with GIST

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  • Data show 66% recurrence-free survival and 92% overall survival at five years following three years of adjuvant therapy with Glivec in patients with resected KIT+ GIST
  • First large Phase III clinical trial to demonstrate survival benefits of extended treatment with Glivec for three years compared to one year following surgery
  • Important finding for treatment of GIST patients who are at risk of recurrence following complete resection of primary tumour

Novartis announced new data today showing a significant improvement in both recurrence-free survival and overall survival for patients taking Glivec® (imatinib)* for three years after surgery to remove KIT (CD117)-positive gastrointestinal stromal tumours (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 Glivec for three years remained free of cancer recurrence (primary endpoint) compared to 48% who had received Glivec for only one year (p<.0001). Moreover, 92% of patients taking Glivec for three years were alive (secondary endpoint) compared to 82% who had received Glivec for only one year (p=.019). 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 multi-centre clinical trial to demonstrate a survival benefit of adjuvant Glivec 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 Glivec.

“This study confirms the hypothesis that extending the duration of Glivec 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 tumours are a rare, life-threatening cancer of the gastrointestinal tract. The major cause of GIST is an abnormal form of the protein KIT, which causes cells to grow uncontrollably and become cancerous. Patients with GIST are at risk of recurrence following complete resection of primary GIST.

“Over the past nine years Glivec has provided KIT+ GIST patients with the first effective drug treatment option in the metastatic setting and later in the adjuvant setting,” said Hervé Hoppenot, President, Novartis Oncology. “Now we see exciting new data showing that by extending post-surgical treatment duration to three years, Glivec has significant impact on overall survival in patients with KIT+ GIST. This is important news for GIST patients and the GIST community.”

Novartis



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