EAST HANOVER, N.J., Jan. 7, 2002 — In an interim analysis of the ongoing Phase III study comparing Gleevec (imatinib mesylate) to standard therapy (interferon injections plus Ara-C [cytarabine] chemotherapy) for initial treatment in newly diagnosed CML patients, the Gleevec arm was found — early on — to demonstrate a substantially higher response. Based on this finding, the Independent Data Monitoring Board (IDMB) has recommended a change in the protocol to enable the patients on standard therapy who have not achieved a major cytogenetic response to switch to Gleevec at this time.

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The changes to the study protocol as recommended by the IDMB (comprised of independent hematologists and a clinical statistician) are being communicated to investigators and patients beginning January 3. These changes allow patients on the control arm who have not achieved a major cytogenetic response after one year of treatment with interferon-alpha and cytarabine to switch to Gleevec. A cytogenetic response is the disappearance or reduction in the number of cancerous cells. Patient consent forms will be changed to inform patients of the new data, and to urge them to speak with their physicians.

Called the IRIS study (International Randomized study of Interferon vs. STI571), this large, international multicenter Phase III trial is evaluating Gleevec vs. the combination of standard interferon and cytarabine as first line therapy in patients with CML. Between June 2000 and January 2001, the ongoing study enrolled 1,106 patients in 177 centers across 16 countries. The study was designed to help determine the long-term outcome (including survival) of patients with newly diagnosed CML treated with Gleevec in comparison to the combination of interferon-alpha and cytarabine.

The Independent Data Monitoring Board further recommended that a formal, peer-reviewed presentation of the 12-month data results be made to the scientific community at the earliest possible opportunity.

Preliminary results from a different and smaller, single-institution study in newly diagnosed CML patients were presented in December 2001 at the annual meeting of the American Society for Hematology. ^** The data from this trial on the use of Gleevec in 47 newly diagnosed patients with early chronic phase CML showed that after three months of treatment, 77% (36 patients) had achieved complete or major cytogenetic responses (Ph<35% Philadelphia chromosome, hallmark of the disease). The hematologic response rate was 98% (46 patients). In comparison, in previously reported studies of other agents (interferon-alpha alone and interferon-alpha with cytarabine and homoharringtonine [Triple Rx]) 2-24% of patients on other treatments achieved complete or major cytogenetic responses after three months of treatment.

Contraindications and Adverse Events

The majority of patients treated with Gleevec experienced adverse events at some time. Most events were of mild to moderate grade, but drug was discontinued for adverse events in 1% of patients in chronic phase, 2% in accelerated phase and 5% in blast crisis. Women of childbearing potential should be advised to avoid becoming pregnant while taking Gleevec. The most common side effects included nausea, fluid retention, vomiting, diarrhea, hemorrhage, muscle cramps, skin rash, fatigue, headache, dyspepsia and dyspnea, as well as neutropenia and thrombocytopenia. Serious and severe side effects, such as hepatoxicity (1.1% to 3.5%), fluid retention syndrome (2% to 10%), neutropenia (8% to 46%) and thrombocytopenia (less than 1% to 31%) have also been reported in some patients. There are no long-term safety data on Gleevec treatment.

In most countries where Gleevec is approved, it is indicated for the treatment of patients with chronic myeloid leukemia (CML) in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy. The effectiveness of Gleevec is based on overall hematologic and cytogenetic response rates. There are no controlled trials demonstrating a clinical benefit, such as improvement in disease-related symptoms or increased survival.

The foregoing release contains forward-looking statements that can be identified by terminology such as "early positive results," "to help determine," "preliminary results," or similar expressions. Such forward-looking statements 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. In particular, management's ability to ensure satisfaction of the FDA's further requirements is not guaranteed and management's expectations regarding further commercialization of Gleevec could be affected by, among other things, additional analysis of data; new data; unexpected clinical trial results for Gleevec in the IRIS trial or other Gleevec clinical trials; 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; and other risks and factors referred to in the Company's current Form 20-F on file with the Securities and Exchange Commission of the United States. 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.

About Novartis

Novartis Oncology is a business unit within Novartis AG (NYSE: NVS), a world leader in healthcare with core businesses in pharmaceuticals, consumer health, generics, eye-care, and animal health. In 2000, the Novartis Group's ongoing businesses achieved collective sales of CHF 29.1 billion (USD 17.2 billion) and a net income of CHF 6.5 billion (USD 3.9 billion). The Group invested approximately CHF 4.0 billion (USD 2.4 billion) in R&D. Novartis AG is headquartered in Basel, Switzerland. Novartis Group companies employ about 70,000 people and operate in over 140 countries around the world.

** Presented by Hagop Kantarjian, MD, Professor of Medicine, Chairman, Department of Leukemia and Chief, Section of Leukemia Developmental Therapeutics, M.D. Anderson Cancer Center, Houston, Texas.

Source: Novartis

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