FRIMLEY, England, December 8 /PRNewswire/ --

- 86 Percent of Patients With Ph+ Chronic Myeloid Leukaemia Treated With Breakthrough Treatment Glivec(R) are Alive After Seven Years(1)

- Treatment Shown to Slow Disease Progression: Only one Patient out of 317 Experienced Disease Progression Between Year Six and Seven of Treatment(1)

- Data Demonstrate Longest Overall Survival Observed to Date in This Disease Area

Nearly nine out of ten patients (86 percent) with a life-threatening leukaemia are still alive seven years after diagnosis when treated with Glivec (imatinib). Data from the largest clinical trial in newly diagnosed patients with Philadelphia chromosome positive (Ph+) chronic myeloid leukaemia (CML) demonstrate the longest overall survival observed to date in this disease area.

Data presented today from the 7-year update of the landmark International Randomized Interferon versus STI571 (IRIS) study also demonstrate an extremely low rate of disease progression. Between years six and seven, only one patient progressed to a more advanced stage of the disease.(1)

CML, one of the most common leukaemias, is a progressive disease. Patients are usually diagnosed in the chronic phase of the disease and then progress through several stages before eventually reaching the final blast crisis phase. Before Glivec's availability in 2001, almost 60 percent of patients treated with interferon alpha (the previous standard treatment for CML) would not survive to five years.(2),(3) Once patients reached the blast crisis stage of the disease, survival was generally limited to only three to six months.(4)

Dr Stephen O'Brien, Senior Lecturer in Experimental Haematology, University of Newcastle, and investigator on the IRIS trial said: CML patients treated with imatinib continue to demonstrate impressive long-term survival. Long-term analyses are offering important new insights and, encouragingly, we're seeing that patients' clinical responses are durable over time.

Lead investigators presented the updated findings from the study involving more than 1,100 newly diagnosed patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukaemia (CML) at the 50th Annual Meeting of the American Society of Haematology (ASH).

Sandy Craine, the first person in Europe to be treated with Glivec, and founder of The CML Support Group in the UK said: Glivec has had an incredible impact on patients. Without this treatment many people with CML would not be alive today. Glivec certainly helped to save my life and it is more than encouraging that so many more people are now able to tell the same story of living long term, probably their natural life span, with what once was a terminal disease.

CML is one of the four most common leukaemias in the world affecting 4000 people in the UK, with around 800 new cases being diagnosed each year.(5) It is the result of an abnormal chromosome which is involved in controlling the production of white blood cells.

References 1. O'Brien S, et al. International Randomized Study of Interferon versus STI571 (IRIS) 7-year follow-up Sustained survival, low rate of transformation and increased rate of major molecular response in patients with newly diagnosed chronic myeloid leukemia in chronic phase treated with imatinib. Abstract # 186. American Society of Haematology 2008 Annual Meeting, San Francisco, CA. 2. O'Brien SG, Guilhot F, Larson RA et al. Imatinib Compared with Interferon and Low-Dose Cytarabine for Newly Diagnosed Chronic-Phase Chronic Myeloid Leukemia. N Engl J Med 2003;348:994-1004 3. Chronic Myeloid Leukaemia Trialists' Collaborative Group. J Nat Can Inst. 1997;89(21):1616-1620 4. Guidance on the use of imatinib for CML, NICE technology Appraisal 70, October 2003 5. CancerBackup, Nice one - CancerBACUP welcomes decision on treatment for leukaemia Last accessed 1 December 2008 6. Faderl S; Talpaz M; Estrov Z; O'Brien S; Kurzrock R; Kantarjian HM. The biology of chronic myeloid leukemia. N Engl J Med. 341:164-72, 1999.

About The International Randomized Interferon versus STI571 (IRIS) Study

Study details

IRIS is an open-label Phase III clinical trial enrolling 1,106 newly diagnosed patients with chronic phase Ph+ CML in 177 centres across 16 countries. There are two arms to the study: one group of patients received Glivec 400 mg per day, while the other received a target dose of interferon (IFN) of 5 MIU/m2/day in combination with cytarabine (Ara-C) 20 mg/m2/day for 10 days each month. Because of tolerability issues, lack of response or loss of response, 65% of patients in the IFN/Ara-C arm crossed over to the Glivec arm, whereas only 3% of patients in the Glivec arm crossed over to the IFN/Ara-C arm.

In IRIS, treatment with Glivec was well-tolerated. No new safety issues were identified between the sixth and seventh years of treatment(1).

About Glivec

Glivec is approved in more than 90 countries including the US, EU and Japan for the treatment of all phases of Ph+ CML. Glivec is also approved in the EU, US and other countries for the treatment of patients with Kit (CD117)-positive gastrointestinal tumours (GIST), which cannot be surgically removed and/or have already spread to other parts of the body (metastasised). In Japan, Glivec is approved for the treatment of patients with Kit (CD117)-positive GIST. In the EU, Glivec is also approved for the treatment of adult patients with newly diagnosed Ph+ acute lymphoblastic leukaemia (Ph+ ALL) in combination with chemotherapy and as a single agent for patients with relapsed or refractory Ph+ ALL. Glivec is also approved for the treatment of adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP) who are not eligible for surgery. Glivec is also approved for the treatment of patients with myelodysplastic/myeloproliferative diseases (MDS/MPD). Glivec is also approved for hypereosinophilic syndrome and/or chronic eosinophilic leukaemia (HES/CEL).

The effectiveness of Glivec is based on overall haematologic and cytogenetic response rates and progression-free survival in CML, on haematological and cytogenetic response rates in Ph+ ALL, and on objective response rates in GIST and DFSP. There are no controlled trials demonstrating increased survival.

Not all indications are available in every country.

About chronic myeloid leukaemia

Chronic myeloid leukaemia (CML) is an abnormality of white blood cell production. CML one of the four most common types of leukaemia affecting approximately 4,000 people in the UK.5 It is the result of a genetic abnormality called the Philadelphia chromosome (Ph+) which is found in up to 95 per cent of patients with CML.(6) There are 800 new cases of CML diagnosed in the UK each year and it accounts for 15 percent of leukaemias in adults.(5),(6) The median age of patients is between 45 to 55 years old, but CML can affect people of all ages.(6)

Most people with CML have the Philadelphia chromosome, which can be detected by laboratory tests. In CML, when the cells divide, part of chromosome 9 (the ABL gene) wrongly moves over to join chromosome 22 where the BCR gene sits. The resulting abnormality is known as Bcr-Abl.(6) The protein (tyrosine kinase) produced by Bcr-Abl stimulates the production of white blood cells by the bone marrow, prevents the white blood cells from maturing and encourages CML cells to divide. Patients with CML are prone to repeated infections because they cannot produce enough normal white blood cells to mount an effective immune response.

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