New Hope for UK Follicular Lymphoma Patients As Zevalin , 90Y -Ibritumomab Tiuxetan, Licenced

New hope for UK Follicular Lymphoma Patients as Zevalin®, [90Y]-ibritumomab tiuxetan, Licenced for First Line Consolidation Therapy

2 year improvement in progression free survival (PFS) shown in patients with advanced follicular lymphoma receiving Zevalin vs, induction chemotherapy alone

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Newbury, Berkshire – 14th May, 2008: Zevalin ([90Y]-ibritumomab tiuxetan) can now be used as first-line consolidation therapy after remission induction in previously untreated patients with follicular lymphoma (FL).1

The European Commission (EC) decision is based on data from the First-line Indolent Trial (FIT) study which showed almost a 2 year improvement in progression free survival (PFS) in patients with advanced FL receiving consolidation treatment with [90Y]-ibritumomab tiuxetan, compared to those patients receiving induction chemotherapy alone.2

Consolidation treatment is a cancer therapy given after the induction therapy (usually chemotherapy) and aims to improve the initial effect of an induction therapy.

“The focus and hope of treatment of follicular lymphoma patients is to achieve remission. First line consolidation treatment with Zevalin offers clear benefits for patients in improving the quality of their response and therefore extending their remission period” said Professor Tim Illidge, a Consultant in Oncology at the ChristieHospital in Manchester and Zevalin investigator. “The availability of Zevalin as consolidation therapy provides clinicians with an innovative treatment option that could help follicular lymphoma patients extend life without disease progression.”

[90Y]-ibritumomab tiuxetan combines the tumor-targeting ability of an anti-CD20 monoclonal antibody and the tumour-destroying power of localised yttrium-90 radiation.3

“For anyone diagnosed with cancer any additional time with family is hugely important and being able to offer follicular lymphoma patients the chance of a survival advantage cannot be under estimated“, said Melanie Burfitt from the Lymphoma Association. “We look forward to continued clinical developments in this area and hope that patients’ continue to be able to access and benefit from the improvements they offer.”

“It is particularly impressive that with one single infusion of Zevalin, we have achieved prolongation of median progression free survival by two years, with a favorable toxicity profile,” said Professor Anton Hagenbeek, Academic Medical Centre, Amsterdam, the Netherlands, lead investigator of the FIT trial. “The results also show that radioimmunotherapy is a very effective single agent in the treatment of follicular lymphoma.”

Zevalin was originally approved in 2004 for adult patients with rituximab relapsed or refractory CD20-positive follicular B-cell NHL in Europe. It remains the only licensed radioimmunotherapy in this indication.4 The recent decision by the European Commission to extend marketing authorisation will provide a much wider group of patients with the chance of prolonged remission and improved response to treatment.1

Lymphoma

Lymphoma is cancer of the lymphatic system5, which is one of the human body’s natural defence systems against infection. There are two main types; Hodgkin’s lymphoma and non-Hodgkin’s lymphoma. Hodgkin's lymphoma was named after the doctor who first described the disease, and is characterised by the presence of Reed-Sternberg cells.The Reed Sternberg cell is not usually found in other lymphomas, so these are called non-Hodgkin lymphoma. This difference is important, because the treatment for Hodgkin and non-Hodgkin lymphomas can be very different6. Follicular NHL accounts for 16% of NHLs and is a cancer of the B-lymphocytes7. Follicular lymphoma can occur any time during adulthood, with around two thirds (69%) of all cases are diagnosed in people over 60 years8. It is equally common in men and women8. The causes of follicular lymphoma are unknown9.

The FIT Study

The [90Y]-ibritumomab tiuxetan FIT trial was a multinational, randomized Phase III trial in 414 patients, which investigated [90Y]-ibritumomab tiuxetan as first-line consolidation therapy given as a single therapeutic dose in patients with advanced (stage III or IV) follicular lymphoma who achieved either a partial remission (PR), unconfirmed complete response (CRu) or complete remission(CR) after receiving induction chemotherapy regimens.2 These data were presented at the American Society of Hematology (ASH) Annual Meeting in December 2007.

The FIT study2 showed a median PFS of 37 months with [90Y]-ibritumomab tiuxetan vs.13.5 months in the control arm (p<0.0001, HR 0.463), an increase of 23.50 months. Subgroup analysis showed a median PFS of 29.7 months for [90Y]-ibritumomab tiuxetan vs. 6.3 months for control arm (p<0.0001) for patients in PR following induction therapy, and 54.6 months for [90Y]-ibritumomab tiuxetan vs. 29.9 months control arm (p=0.01) for patients in CR, respectively. [90Y]-ibritumomab tiuxetan consolidation of first remission after induction therapy in advanced stage FL is highly effective with a favourable toxicity profile. 77% of patients in PR converted to CR with 87% of patients in CR(u) and prolongation of PFS by 2 years.

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Contacts:

NOTES TO EDITORS:

Glossary

Follicular lymphomaA type of non-Hodgkin’s Lymphoma (NHL)

IndolentlymphomaA slow growing lymphoma

Progression free survivalThe time that a patient lives without evident tumour growth

Consolidation therapyIs cancer treatment given after induction therapy to consolidate the gains obtained, further reduce the number of cancer cells and achieve a complete remission. Often just called consolidation.

ECEuropean Commission

RemissionA complete or partial disappearance of the signs and symptoms of disease in response to treatment. The period during which a disease is undercontrol

[90Y]-ibritumomab tiuxetan

[90Y]-ibritumomab tiuxetan is a type of targeted cancer therapy called radioimmunotherapy. Radioimmunotherapy combines the use of a monoclonal antibody to target specific tumour cells within the body and a radioisotope to kill the targeted lymphoma cells, through several layers of tumour cells. [90Y]-ibritumomab tiuxetan combines the tumour-targeting ability of an anti-CD20 monoclonal antibody and the tumour-destroying ability of localized yttrium-90 [90-Y] radioisotope beta-radiation, resulting in a significantly higher overall response rate compared to non-radiolabelled immunotherapy alone.3 [90Y]-ibritumomab tiuxetan has been approved for adult patients with rituximab-relapsed or refractory CD20-positive follicular B-cell non-Hodgkin’s lymphoma in UK since 2004.

Rituximab pre-treatment is necessary to clear circulating B-cells, enabling [90Y]-ibritumomab tiuxetan to deliver radiation more specifically to the lymphomas.

First-line Consolidation Therapy

Consolidation therapy is a treatment regimen given after a patient responds to initial first-line induction therapy (e.g. chemotherapy). The aim of consolidation therapy is to rapidly improve the quality of a patient’s response, thereby extending the response duration.

Bayer Schering Pharma:

Bayer Schering Pharma is a leading, worldwide speciality pharmaceutical company. Its research and business activities are focussed on the fields of oncology, haematology & cardiology, diagnostic imaging, primary care, specialised therapeutics and women’s healthcare. With innovative products and using new ideas, Bayer Schering Pharma aims to make a contribution to medical progress and strives to improve the quality of life of patients - a factor of particular importance in Oncology.

Bayer Schering Pharma’s portfolio of oncology products includes treatments for both solid and haematological malignancies. Intensive research is ongoing as Bayer Schering Pharma strives to discover and advance therapeutic solutions for the benefit of all cancer patients.

For more information, please visit

Zevalin® ([90Y]-ibritumomab tiuxetan) is a registered trademark of Bayer Pharmaceuticals Corporation.

References:

1. EMEA:
2. FIT trial: [90Y]-ibritumomab tiuxetan ([90Y]-ibritumomab tiuxetan) consolidation of first remission in advanced stage follicular NHL: First results of the international randomized Phase 3 First-line Indolent Trial (FIT) in 414 Patients.Abstract# 643. This data was presented at the American Society of Hematology (ASH) Annual Meeting in December 2007.
3. Witzig TE et al. Randomized controlled trial of yttrium-90-labeled ibritumomab tiuxetan radioimmunotherapy versus rituximab immunotherapy for patients with relapsed or refractory low-grade, follicular, or transformed B-cell non-Hodgkin's lymphoma.J Clin Oncol. 2002 May 15; 20(10):2453-63. (efficacy superior to antibody alone)

1. Zevalin Summary of Product Characteristics (April 2008)

1. Cancer Research UK Accessed 12 May 2008

1. Cancerbackup Accessed 12 May 2008

1. Accessed 12 May 2008

1. Cancer Research UK Accessed 12 May 2008

1. Cancer Backup Accessed 12 May 2008

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