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04/06/2007, 08.00 AM CET
Study shows one year of Glivec® reduces risk of cancer returning by 82% following surgery for gastrointestinal stromal tumors
Authors suggest highly significant findings could lead to change in clinical practice recommendations   Results prompted study organizers to offer Glivec to patients on placebo   Global regulatory submissions in adjuvant GIST planned for early 2008   Basel, June 4, 2007 - Study results presented today show one year of treatment with Glivec® (imatinib)[1] dramatically reduced the risk of cancer returning by 82% in patients with Kit-positive gastrointestinal stromal tumors (GIST), when given following surgery to remove primary tumors.   New data from the international clinical trial, sponsored by the US National Cancer Institute (NCI), were presented at the 43rd American Society of Clinical Oncology's annual meeting in Chicago.   Researchers found that out of 644 patients with primary GISTs that were resectable (i.e. could be removed by surgery), 97% of those who received Glivec after surgery were alive after one year with no sign of the cancer coming back, compared to 83% of patients who received placebo (p<0.001). After two years, 90% of Glivec patients were alive without any sign of the cancer returning compared to 71% of patients receiving placebo.   "This highly significant result could prompt re-evaluation of clinical practice recommendations for management of intermediate- and high-risk primary resectable GISTs," said principal investigator Ronald DeMatteo, MD, Memorial Sloan-Kettering Cancer Center, New York, US. "Conventional chemotherapy agents have been notoriously ineffective in GIST. This study demonstrated for the first time that targeted molecular therapy reduces the rate of recurrence after complete removal of a primary GIST."   NCI announced in April 2007 that the committee overseeing the trial had halted further enrolment because the primary endpoint of increasing recurrence-free survival had been met. Patients in the study who were being treated with placebo were offered one year of Glivec treatment.   Novartis expects to file global regulatory submissions for use of Glivec as adjuvant (i.e. post-surgical) therapy in GIST patients following surgery to remove primary tumors by early 2008.   Gastrointestinal stromal tumors belong to a group of cancers known as soft tissue sarcomas that usually arise from the intestinal tract, with the most common site being the stomach followed by the small intestine. Estimates of the incidence of GIST in the US vary, but experts believe there are between 1,500 and 6,000 new cases each year. Although surgery cures some patients with GIST, the recurrence rate is high.   "These results provide compelling evidence that Glivec may dramatically improve treatment for patients across the spectrum of this disease," said Diane Young, MD, Head of Global Medical Affairs at Novartis Oncology. "In keeping with our commitment to providing useful medicines to patients with critical unmet medical needs, we are working closely with the investigators and will prepare regulatory submissions to gain approval for Glivec as adjuvant treatment for GIST."   Patients participated through one of five NCI-sponsored North American Cooperative Oncology Groups, led by the American College of Surgeons Oncology Group and including Cancer and Leukemia Group B, Eastern Cooperative Oncology Group, Southwest Oncology Group, and the National Cancer Institute of Canada Clinical Trials Group.   Glivec therapy was generally well tolerated by most patients in the adjuvant GIST study, with side effects similar to those observed in other GIST clinical trials with Glivec including (but not limited to) nausea, diarrhea and swelling (edema).   Glivec is indicated for the treatment of patients with Kit (CD117)-positive unresectable and/or metastatic malignant gastrointestinal stromal tumors. The effectiveness of Glivec in GIST is based on objective response rate. There are no controlled trials demonstrating a clinical benefit, such as improvement in disease-related symptoms or increased survival.   Novartis supplied Glivec for use in the study, and also provided partial funding under a Cooperative Research and Development Agreement with NCI to support the clinical development of Glivec.   Glivec contraindications, warnings and adverse events The majority of patients treated with Glivec in clinical trials experienced adverse events at some time. Most events were of mild to moderate grade and treatment discontinuation was not necessary in the majority of cases.   The safety profile of Glivec was similar in all indications. The most common side effects included nausea, superficial edema, muscle cramps, skin rash, vomiting, diarrhea, abdominal pain, myalgia, arthralgia, hemorrhage, fatigue, headache, joint pain, cough, dizziness, dyspepsia and dyspnea, dermatitis, eczema, fluid retention, as well as neutropenia, thrombocytopenia and anemia. Glivec was generally well-tolerated in all of the studies that were performed, either as monotherapy or in combination with chemotherapy, with the exception of a transient liver toxicity in the form of transaminase elevation and hyperbilirubimaemia observed when Glivec was combined with high dose chemotherapy.   Patients with cardiac disease or risk factors for cardiac failure should be monitored carefully and any patient with signs or symptoms consistent with cardiac failure should be evaluated and treated. Cardiac screening should be considered in patients with HES/CEL, and patients with MDS/MPD or SM with high level of eosinophils (echocardiogram, serum troponin level).   Rare/serious adverse reactions include: sepsis, pneumonia, depression, convulsions, cardiac failure, thrombosis/embolism, ileus, pancreatitis, hepatic failure, exfoliative dermatitis, angioedema, Stevens-Johnson syndrome, renal failure, fluid retention, edema (including brain, eye, pericardium, abdomen and lung), hemorrhage (including brain, eye, kidney and gastrointestinal tract), diverticulitis, gastrointestinal perforation, tumour hemorrhage/ necrosis, hip osteonecrosis/avascular necrosis.   Glivec is contraindicated in patients with known hypersensitivity to imatinib or any of its excipients. Women of childbearing potential should be advised to avoid becoming pregnant while taking Glivec.   Disclaimer The foregoing release contains forward-looking statements that can be identified by terminology such as "could affect/change," "could prompt re-evaluation," "increased survival," "may dramatically improve," "are working closely," "planned" or similar expressions, or by express or implied discussions regarding potential new indications for Glivec or potential future sales of Glivec, or regarding the long-term impact of a patient's use of Glivec. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results with Glivec to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that Glivec will be approved for any additional indications in any market. Nor can there be any guarantee regarding potential future sales of Glivec. Neither can there be any guarantee regarding the long-term impact of a patient's use of Glivec. In particular, management's expectations regarding commercialization of Glivec could be affected by, among other things, additional analysis of Glivec clinical data; new clinical data; unexpected clinical trial results; unexpected regulatory actions or delays or government regulation generally; the company's ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; government, industry, and general public pricing pressures; and other risks and factors referred to in the Company's current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Novartis is providing this information as of this date and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.   About Novartis Novartis AG (NYSE: NVS) is a world leader in offering medicines to protect health, cure disease and improve well-being. Our goal is to discover, develop and successfully market innovative products to treat patients, ease suffering and enhance the quality of life. We are strengthening our medicine-based portfolio, which is focused on strategic growth platforms in innovation-driven pharmaceuticals, high-quality and low-cost generics, human vaccines and leading self-medication OTC brands. Novartis is the only company with leadership positions in these areas. In 2006, the Group's businesses achieved net sales of USD 37.0 billion and net income of USD 7.2 billion. Approximately USD 5.4 billion was invested in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 100,000 associates and operate in over 140 countries around the world. For more information, please visit http://www.novartis.com.    [1] Known as Gleevec® (imatinib mesylate) in the US, Canada and Israel     # # #   Novartis Media Relations   Geoffrey Cook Novartis Oncology +1 862 778 2675 (direct) +1 973 652 7927 (mobile) geoffrey.cook@novartis.com   Corinne Hoff Novartis Global Media Relations +41 61 324 9577 (direct) +41 79 248 5717 (mobile) corinne.hoff@novartis.com     Novartis Investor Relations   International   Ruth Metzler-Arnold             +41 61 324 7944 Katharina Ambühl             +41 61 324 5316 Nafida Bendali             +41 61 324 3514 Jason Hannon             +41 61 324 2152 Thomas Hungerbuehler             +41 61 324 8425 Richard Jarvis             +41 61 324 4353     North America   Ronen Tamir             +1 212 830 2433 Arun Nadiga             +1 212 830 2444 Jill Pozarek             +1 212 830 2445 Edwin Valeriano             +1 212 830 2456   e-mail: investor.relations@novartis.com   Attachments: Media release (PDF)