Early action against rare cancer reduces relapse risk

Health Canada approves first post-surgical treatment for patients with gastrointestinal stromal tumours

DORVAL, QC, Jan. 26 /CNW/ - Patients with gastrointestinal stromal tumours (GIST) can now take action at an earlier stage of this rare form of cancer to reduce the risk of their disease returning following surgery. Novartis Pharmaceuticals Canada announced today that Gleevec* (imatinib mesylate) has received conditional approval by Health Canada for the adjuvant (post-surgical) treatment of adult patients who are at intermediate to high risk of disease recurrence following the surgical removal of GIST.

Gleevec* is now the only adjuvant treatment indicated to delay or prevent the return of this highly aggressive cancer, filling a major unmet medical need and giving new hope to GIST patients. Clinical study results published in The Lancet in March, 2009 showed the risk of GIST recurring is reduced by 89% as a result of using adjuvant therapy with Gleevec*, with an almost two-fold longer recurrence-free survival (RFS) compared to placebo.(1)

GIST is a life-threatening disease, and the most common form of gastrointestinal tract cancer. After initial removal, GIST tumours can return in as many as one of two patients.(2) Recurrent GISTs are often more aggressive than primary tumours, with relapses associated with lower survival rates.(3)

"Prior to this approval, observation has been the standard of care after surgical removal of primary GIST, with a significant number of patients facing postoperative recurrence or metastasis of their disease," said Dr. Martin Blackstein, Medical Oncologist, Mount Sinai Hospital in Toronto. "The approval of Gleevec in the adjuvant setting impacts the course of the disease by delaying, and in some cases preventing, disease recurrence."

Gleevec* is now approved for 10 indications, including the treatment of Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) and Kit (CD117)-positive gastrointestinal stromal tumours which cannot be surgically removed and/or have already spread to other parts of the body (metastasized).(4)

Filing data

This approval was based on data from a National Cancer Institute-sponsored Phase III study that showed a dramatic reduction after one year in the return of GIST after surgery in patients treated with Gleevec* versus placebo. The final data from the study, as published in The Lancet, showed an estimated one-year, recurrence-free survival of 98% for GIST patients taking Gleevec versus 83% taking placebo.(1)

The study was a double-blind, randomized, multicentre, international study of more than 700 GIST patients throughout the US and Canada who had undergone surgery to remove their tumours. The primary efficacy endpoint of the study was recurrence-free survival (RFS), defined as the time from the date of randomization to the date of recurrence or death from any cause. Participants were randomized to receive either Gleevec* 400 mg/day or a matching placebo for one year.(1)

With a median follow-up of 19.7 months, there were 30 RFS events out of 359 patients in the Gleevec* arm (8%) compared to 70 RFS events out of 354 patients in the placebo arm (20%) (hazard ratio=0.35 (95% CI: 0.22, 0.53), p less than 0.0001). This follow up is too short to evaluate survival.(1)

The study, known as ACOSOG Z9001, was conducted at multiple cancer centres, including centres in Canada, under a Cooperative Research and Development Agreement between Novartis and the National Cancer Institute. The study was led by the American College of Surgeons Oncology Group (ACOSOG) in association with the Duke Clinical Research Institute.(1)

The investigators reported that Gleevec* therapy was generally well tolerated by most patients, with side effects similar to those observed in previous clinical trials with Gleevec*. The most frequently reported adverse reactions were diarrhea, fatigue, nausea, edema, decreased hemoglobin, rash, vomiting and abdominal pain. No new adverse reactions were reported in the adjuvant GIST treatment setting that had not been previously reported in other patient populations including patients with unresectable and/or malignant metastatic GIST.(1)

For detailed study and safety information please see the approved Gleevec Product Monograph.

About gastrointestinal stromal tumours

Gastrointestinal stromal tumours (GIST) belong to a group of cancers known as soft tissue sarcomas. The most common sarcomas, they can be found most often in the stomach and small intestine. The true incidence and prevalence are difficult to determine because the diagnosis of GIST has only recently been well-defined. However, a Swedish study has estimated an incidence of primary GIST of 14.5 and a prevalence of 129 individuals per million population. This represents approximately 500 newly-diagnosed Canadians per year.(5)

Important safety information(4)

The majority of patients treated with Gleevec 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 Gleevec* 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 and fluid retention, as well as neutropenia, thrombocytopenia and anemia. Gleevec* 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 hyperbilirubinemia observed when Gleevec* was combined with high dose chemotherapy.

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, tumor hemorrhage/necrosis and hip osteonecrosis/avascular necrosis.

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 with high level of eosinophils (echocardiogram, serum troponin level).

Gleevec* 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 Gleevec*.

Disclaimer

The foregoing release contains forward-looking statements that can be identified by terminology such as "risk," "can," "likelihood," "aimed to," "will," or similar expressions, or by express or implied discussions regarding potential new indications or labelling for Gleevec* or regarding potential future revenues from Gleevec*. You should not place undue reliance on these statements. Such forward-looking statements reflect the current views of management regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results with Gleevec* to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that Gleevec* will be approved for any additional indications or labeling in any market. Nor can there be any guarantee that Gleevec* will achieve any particular levels of revenue in the future. In particular, management's expectations regarding Gleevec* could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally; unexpected clinical trial results, including unexpected new clinical data and unexpected additional analysis of existing clinical data; 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; the impact that the foregoing factors could have on the values attributed to the Novartis Group's assets and liabilities as recorded in the Group's consolidated balance sheet, and other risks and factors referred to in Novartis AG'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 the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About Novartis Pharmaceuticals Canada

Novartis Pharmaceuticals Canada Inc., a leader in the healthcare field, is committed to the discovery, development and marketing of innovative products to improve the well-being of all Canadians. Novartis Pharmaceuticals Canada Inc. conducts hundreds of clinical trials across the country seeking new treatments for cardiovascular disease, oncology, diabetes, cancer, ophthalmology and organ transplantation. In 2008, the Company invested close to $96 million in research and development. Novartis Pharmaceuticals Canada Inc. employs more than 750 people in Canada and its headquarters are located in Dorval, Québec. In addition to Novartis Pharmaceuticals Canada Inc., the Novartis Group in Canada consists of Novartis Animal Health Canada Inc., Novartis Consumer Health Canada Inc., CIBA Vision Canada Inc. and Sandoz Canada Inc. For further information about Novartis Canada, please consult www.novartis.ca.

    
    References

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    (1) DeMatteo, R. et al. Adjuvant imatinib mesylate after resection of
        localized, primary gastrointestinal stromal tumour: a randomized,
        double-blind, placebo-controlled trial. The Lancet. Published online
        March 19, 2009. Accessed March 2009. http://www.thelancet.com.
    (2) Van den Abbeele A., Benjamin R., Blanke C, et al. Clinical Management
        of GIST. Recurrence patterns and prognostic factors for survival.
        2003;1-24.
    (3) Life Raft Group. Managing Initial Recurrence.
        http://www.liferaftgroup.org/gist_recurrence.html. Accessed November
        2008
    (4) Gleevec* (imatinib mesylate) product monograph; December 21, 2009.
    (5) Nilsson B., Bumming P., Meis-Kindblom JM., et al. Gastrointestinal
        stromal tumours: the incidence, prevalence, clinical course, and
        prognostication in the preimatib mesylate era. Cancer. 2005;
        103:821-9.
    * Gleevec is a registered trademark.
    

SOURCE Novartis Pharmaceuticals Canada Inc.

For further information: For further information: about this news release, please contact: Lise Huneault, Novartis Pharmaceuticals Canada Inc., (514) 631-6775, ext. 1203, lise.huneault@novartis.com


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