More patients expected to survive blood cancer

News Release

More patients expected to survive aggressive blood cancer
- new funding great news for New Zealanders

Auckland, 2nd February 2004 – Each year an additional 30 - 35 people2 who are diagnosed with aggressive blood cancer may live beyond 2006 thanks to a new funding agreement for targeted cancer therapy MabThera.

MabThera supplier Roche Products and pharmaceutical management agency PHARMAC have agreed to funding MabThera for people with an aggressive form of Non-Hodgkins Lymphoma (NHL) until the
1st July 2004 when ongoing funding will be taken over by DHB Hospitals. Until now MabThera was only funded for patients with the low-grade (indolent) form of NHL.

“Patients diagnosed with aggressive NHL often have a short time to start treatment as the disease can progress very quickly. The improved survival rates for people who use MabThera are encouraging and will give patients a better chance to beat the disease. Our organisation has contact with patients who will be delighted to hear this news,” said Pru Etcheverry, Executive Director of the Leukaemia and Blood Foundation.

The agreement follows the results of a European study that showed MabThera used in combination with standard chemotherapy improved the chance of survival three years later by 22%.1

Approximately 6002 new cases of Non-Hodgkin’s lymphoma are diagnosed in New Zealand each year – approximately half of these cases have the aggressive form of the disease.3 NHL affects the body’s immune system preventing the body from protecting itself against infection and disease. The aggressive form of NHL spreads rapidly through the body if left untreated, and generally has a poor prognosis. NHL is the third fastest growing cancer worldwide behind skin and lung cancer.3

Roche Products (NZ) Ltd Managing Director Rob Mitchell said it was a very positive step forward for oncology treatment in New Zealand. “Many New Zealanders have already benefited from MabThera in the low-grade form of NHL and now this will include the 120-130 patients each year who develop aggressive NHL.”

The exact cause of NHL remains unknown, but the specific cells it affects in the body have been identified. MabThera has been designed to specifically target these cells and recruit the body’s natural defences to destroy them.3

MabThera was discovered by IDEC Pharmaceuticals Corporation and was jointly developed by IDEC, Genentech, Roche and Zenyaku Kogyo.

About Roche

Roche Products (NZ) Ltd is committed to providing innovative products for cancer care in New Zealand. Headquartered in Basel, Switzerland, Roche is one of the world’s leading research-orientated health groups in the fields of pharmaceuticals and diagnostics and is the leading oncology company. Roche’s products and services address prevention, diagnosis and treatment of disease, enhancing well-being and quality of life. Roche employs some 62 000 people in more than 150 countries around the world. The company has business alliances and R&D relationships with numerous partners, including majority ownership interests in Genentech and Chugai, which are both members of the Roche Group.

References

1. Coiffier B et al. GELA Study Comparing CHOP and R-CHOP in Elderly Patients with DLCL: 3-Year Median Follow-up with an Analysis According to Comorbidity Factors. 2395. ASCO Conference, 39th. 31 May – 3 June 2003. Chicago, USA.
2. New Zealand Health Information Service Health Statistics. Cancer Deaths and New Registrations. [Internet]. Available from . Accessed 13 March 2003.
3. Facts: Non-Hodgkins Lymphoma.

TAPS: PP945

MabThera® (rituximab) is a Prescription Medicine used to treat non-Hodgkin’s lymphoma (a type of blood cancer).

Possible unwanted effects include: Common: fever, chills and severe shivering; nausea; fatigue; headache; runny nose; pain where the lymphoma is located; hypotension; flushing; pain at site of infusion. Rare (serious): severe skin rash, itching, hives; severe swelling of the face, lips, mouth, throat, hands, feet or ankles; severe shortness of breath, difficulty breathing, wheezing or coughing; signs of infection.

MabThera should not be used if you are pregnant or breastfeeding. Tell your doctor if you have any other health problems including: heart disease, certain blood disorders (e.g. low white blood cells or platelets), or lung disease.

Ask your doctor if MabThera is right for you. Use strictly as directed. If symptoms continue or you experience side effects or would like further information please talk to your doctor or pharmacist or visit www.medsafe.govt.nz for MabThera Consumer Medicine Information. Mabthera (100mg/10ml and 500mg/50ml single use vials) is a funded medicine under Section H of the Pharmaceutical Schedule for patients who meet pre-defined criteria. A prescription charge and normal oncologists fees may apply.

FACTS: GELA Study

 The GELA study, a phase III clinical study, was conducted by Groupe d’Etude des Lymphomes de l’Adulte (GELA), a cancer co-operative group of over 110 institutions in France, Belgium and Switzerland.1

 The GELA study was based on 398 previously untreated elderly patients with aggressive non-Hodgkin’s Lymphoma (NHL). Patients were randomly assigned to receive standard CHOP chemotherapy alone (every three weeks for eight cycles) or MabThera plus CHOP. MabThera was administered on day 1 of each cycle of CHOP for the eight cycles.1

 The findings of the pivotal two year GELA study show that a new medicine combination of MabThera (rituximab) plus CHOP (standard chemotherapy) increases the patients’ chance of survival without a clinically significant increase in toxicity.1

 The findings of the three year median follow-up of the GELA study showed the benefit of MabThera plus CHOP over standard chemotherapy (CHOP) was maintained.2

FACTS: About MabThera

 The development and availability of MabThera for aggressive NHL has provided the first improvement in survival compared with standard CHOP chemotherapy in more than 20 years.3

 For aggressive NHL, the current standard of care is CHOP chemotherapy, which is curative in about 30% of patients with stage III/IV disease.4

 The GELA study now shows that patients receiving MabThera + CHOP have a 22% relative increase in survival and a 51% relative increase in event free survival at 3 years.2

 MabThera, when combined with CHOP, is more effective than conventional chemotherapy alone.1,2

 It is the first new medicine combination to show an improvement in overall survival for patients with aggressive NHL.1,3

MabThera is a specifically engineered antibody, which is designed to target specific lymphoma cells. Once MabThera binds to these cells, the immune system is then able to recognise and kill them.5

MabThera specifically targets a protein called CD20, which is found only on the surface of mature B-lymphocytes, a type of white blood cell. MabThera does not affect any other cells, which may also explain why generally the side effects are mild to moderate and are mostly limited to the first infusion.5

References
1. Coiffier, B, et al. CHOP Chemotherapy Plus Rituximab Compared with CHOP Alone in Elderly Patients with Diffuse Large B-Cell Lymphoma. N Engl J Med, 2002. 346:235-242.
2. Coiffier, B, et al. GELA Study Comparing CHOP and R-CHOP in Elderly Patients with DLCL: 3-Year Median Follow-up with an Analysis According to Co-Morbidity Factors. ASCO Annual Meeting. 2003. Chicago, USA.
3. Horning, S. Introduction. Sem Oncol. 2003. 30:1(2);1-2.
4. Coiffier, B. Immunochemotherapy: The New Standard in Aggressive Non-Hodgkin’s Lymphoma in the Elderly. Sem Oncol. 2003. 30:1(2);21-27.
5. MabThera International Product Monograph, 3rd Edition. F-Hoffman La Roche. Basel, Switzerland.

FACTS: NHL in New Zealand

 In New Zealand, an estimated 600 new cases of NHL are diagnosed annually.1

 NHL is the sixth most common cancer in New Zealand.1

 Low-grade lymphomas are more common in New Zealanders over the age of 60.1,2

 The most common form of treatment for NHL in New Zealand is chemotherapy, which aims to kill cancer cells while causing the least possible damage to normal cells.3

 When used alone, standard chemotherapy has about a 30% cure rate of treating aggressive NHL.4

 Between 1987 – 1997 in New Zealand, the incidence of NHL cancer has increased by 200%.5

 The average cost of MabThera in $NZ is around $13,000 (excl GST) for a four week course of treatment for low-grade NHL (this figure will vary depending on the number of cycles given and the size of the person). Because the course of treatment for aggressive NHL is longer, the cost is higher.6

 MabThera is currently registered and funded for the treatment of relapsed low-grade NHL. MabThera is registered and now funded for the treatment of Aggressive Diffuse Large B-Cell NHL.7

References
6. Selected Health Statistics: Cancer Deaths and New Registrations. [Internet. ] Provisional Data, New Zealand Health Information Service. Available from . 13/03/2003.
7. Coiffier, B. Non-Hodgkin’s Lymphomas. Clinical presentation, treatment and outcome.
8. Collins, A. Treatment of Low Grade NHL and Initial Reaction to MabThera. Collins Research. Dec 2002.
9. Coiffier, B. Immunochemotherapy: The New Standard in Aggressive Non-Hodgkin’s Lymphoma in the Elderly. Sem Oncol. 2003. 30:1(2);21-27.
10. New Zealand Health Information Service. Cancer Registrations 1948 to 1998.
11. MabThera (rituximab) 100mg & MabThera 500mg Vials Pricing Information. Data on file: Roche Products (New Zealand) Ltd, 8 Henderson Place, Te Papapa, Auckland. August 2003.
12. MabThera (rituximab) Data Sheet, 12 February 2003. Data on file: Roche Products (New Zealand) Ltd, 8 Henderson Place, Te Papapa, Auckland.

FACTS: Non-Hodgkin’s Lymphoma

 Non-Hodgkin’s Lymphoma (NHL) is a type of white blood cancer. It is not a single disease but one that affects various parts of the body’s immune system. NHL can develop wherever in the body white blood cells can be found. The lymphatic system is a vital part of the body’s immune system, which plays a key role in defending the body against cancer and other diseases.1

 NHL is the third fastest increasing cancer worldwide, behind skin and lung cancer.1

 NHL is grouped into low, intermediate and high grades depending on the rate of tumour growth. 1

 Low-grade NHL is more difficult to diagnose due to it’s slow rate of growth. Standard treatments cannot cure the disease but patients may live many years with the disease being managed.1

 Aggressive (high-grade) NHL spreads rapidly through the body and can be fatal within a year or two if left untreated.1

 Those patients who are diagnosed and treated at an early stage are more likely to be cured within several years.2

 Approximately 1.5 million people worldwide are living with NHL and an estimated 300,000 die each year.3

 Approximately 50% of cases diagnosed are of the aggressive form of the disease.4

 Since the early 1970s, global incidence of NHL has grown by approximately 80%.3

 The exact cause of NHL remains unknown, however, genetic factors and immune system diseases such as HIV may contribute.1

References
13. Patlak, M. Non-Hodgkin’s Lymphoma Becomes More Common, More Treatable. [Internet.] U.S. Food and Drug Administration. Available from: www.fda.gov. 01/08/2003.
14. Armitage, J et al. Text Atlas of Lymphomas. Revised Edition. Martin Dunitz Ltd, United Kingdom. 1999.
15. World Health Report 2000, World Health Organisation, www.who.int.
16. Vose, JM. Phase II Study of Rituximab in Combination With CHOP Chemotherapy in Patients With Previously Untreated, Aggressive Non-Hodgkin’s Lymphoma. J Clin Oncol. 2001. 19:2;389-397.

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