Novartis drug Glivec® shows significant overall survival benefit

NovartisNovartis announced new data 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 tumors (GIST) compared to one year of treatment.

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.[1]

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 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 tumors are a rare, life-threatening cancer of the gastrointestinal tract. The major cause of GIST is an abnormal form of the protein KIT,[2] which causes cells to grow uncontrollably and become cancerous. Patients with GIST are at risk of recurrence following complete resection of primary GIST.[3]

"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."

Study details
The SSG XVIII clinical trial was conducted by the Scandinavian Sarcoma Group (SSG), and the Sarcoma Group of the Arbeitsgemeinschaft Internistische Onkologie (AIO). SSG XVIII is a multicenter, prospective, randomized study for the evaluation of adjuvant treatment with Glivec of histologically verified KIT+ GIST with a greater than 50% risk of GIST recurrence despite complete removal of all macroscopic GIST tissue at surgery.[4]

The primary endpoint of the study was to compare the recurrence-free survival in GIST patients with a greater than 50% estimated risk of disease recurrence within the first five years following the diagnosis and treatment with adjuvant Glivec for 12 or 36 months. The secondary endpoints included overall survival and treatment safety.[1]

Four hundred patients entered the study and the median follow-up was 54 months. Recurrence-free survival was longer in the 36-month group compared to the 12-month group (HR 0.46, 95% CI 0.32-0.65; p<.0001; five-year recurrence-free survival 66% vs. 48%, respectively). Patients assigned to 36 months of Glivec had longer overall survival (HR 0.45, 95% CI 0.22-0.89; p=.019; five-year overall survival 92% vs. 82%, respectively). Glivec was generally well tolerated. The proportion of patients who discontinued Glivec during the assigned treatment period for reasons other than GIST recurrence was 26% in the 36-month group and 13% in the 12-month group.[1]

About Glivec
Glivec is approved in more than 110 countries, including the US, EU and Japan, for the treatment of all phases of Ph+ CML. Glivec is also approved in the US, EU and other countries for the treatment of patients with KIT (CD117)-positive gastrointestinal stromal tumors (GIST), which cannot be surgically removed and/or have already spread to other parts of the body (metastasized). In the US and EU, Glivec is approved for the post-surgery treatment of adult patients following complete surgical removal of KIT (CD117)-positive gastrointestinal stromal tumors.

About Novartis
Novartis provides healthcare solutions that address the evolving needs of patients and societies. Focused solely on healthcare, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care, cost-saving generic pharmaceuticals, consumer health products, preventive vaccines and diagnostic tools. Novartis is the only company with leading positions in these areas. In 2010, the Group's continuing operations achieved net sales of USD 50.6 billion, while approximately USD 9.1 billion (USD 8.1 billion excluding impairment and amortization charges) was invested in R&D throughout the Group. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 119,000 full-time-equivalent associates and operate in more than 140 countries around the world.

1. Joensuu H, et al. Twelve vs. 36 months of adjuvant imatinib (IM) as treatment of operable GIST with a high risk of recurrence: Final results of a randomized trial (SSGXVIII/AIO). 47th Annual Meeting of the American Society of Clinical Oncology. Abstract No. LBA1. June 5, 2011.
2. Gomes AL, Bardales RH, Milanezi F, Reis RM, Schmitt F. Molecular analysis of c-KIT and PDGFRA in GISTs diagnosed by EUS. Am J Clin Pathol. 2007 Jan;127(1):89-96.
3. DeMatteo RP, Lewis JJ, Leung D, Mudan SS, Woodruff JM, Brennan MF. Two hundred gastrointestinal stromal tumors: recurrence patterns and prognostic factors for survival. Ann Surg. 2000 Jan;231(1):51-8.
4. Study Comparing 12 Months Versus 36 Months of Imatinib in the Treatment of Gastrointestinal Stromal Tumor (GIST). Available at http://clinicaltrials.gov/show/NCT00116935. Accessed on April 11, 2011.

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