New Study Offers Hope For Patients With Advanced Follicular Lymphoma

Main Category: Lymphoma / Leukemia / Myeloma
Article Date: 12 Dec 2007 - 13:00 PDT

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New data presented at the Congress of the American Society of Hematology (ASH) on the First-line Indolent Trial (FIT) study shows nearly a 2 year improvement in progression free survival (PFS) in patients with advanced follicular lymphoma receiving Zevalin® ([90Y]-ibritumomab tiuxetan) vs, induction chemotherapy alone.1

Professor John Radford, a Consultant in Medical Oncology at the Christie Hospital in Manchester and FIT trial investigator said: "For many people with this type of lymphoma their main hope is to stay in remission for as long as possible. The FIT study shows that Zevalin, given after initial chemotherapy, produces nearly 2 additional years free of disease progression."

The [90Y]-ibritumomab tiuxetan FIT trial (First-line Indolent 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 at least a partial remission (PR), unconfirmed complete response (CRu) or complete remission (CR) after receiving induction chemotherapy regimens.1

The FIT study1 showed a median PFS of 37 months with [90Y]-ibritumomab tiuxetan vs. 13.5 months in the control arm (p<0.0001). 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. Further, after [90Y]-ibritumomab tiuxetan consolidation 77% of patients in PR after induction therapy converted to CR. In total, 87% of [90Y]-ibritumomab tiuxetan patients responded, with 76% in CR and 11% in CRu. The adverse event profile was similar to that seen in other studies with [90Y]-ibritumomab tiuxetan.

Non-Hodgkin's Lymphoma (NHL) is the 6th most common cancer in the UK.2,3 Follicular lymphoma accounts for around a quarter of all NHL cases.4

"Despite non-Hodgkin's lymphoma being the 6th most common type of cancer in the UK, it is not a well known disease and many patients first hear of it on diagnosis. Radioimmunotherapy is a type of cancer therapy which targets and treats the cancer cells more specifically, with the aim of causing less damage to the healthy cells, in comparison to conventional radiotherapy or chemotherapy. The FIT data is encouraging in that it demonstrates the ability of Zevalin to extend remission and increase response rates in patients who have been treated with combination chemotherapy." said Melanie Burfitt from the Lymphoma Association.

[90Y]-ibritumomab tiuxetan is a type of targeted cancer therapy called radioimmunotherapy. Radioimmunotherapy combines the use of a monoclonal antibody and a radioisotope to target and destroy specific cells. The radioisotope used is Yttrium-90. The radiolabelled antibodies can specifically bind to the tumour, thus killing targeted lymphoma cells, through several layers of tumour cells. [90Y]-ibritumomab tiuxetan is a treatment for patients with a type of slow growing lymphoma known as B- cell follicular lymphoma that has stopped responding to most other treatments.

[90Y]-ibritumomab tiuxetan patients' radiation exposure was also analysed, in patients for whom dosimetry data were available(n=57). Overall the results confirmed that radiation exposure with [90Y]-ibritumomab tiuxetan treatment was within acceptable limits to normal organs. Overall haematologic toxicity was not correlated with radiation dose estimates. These findings are consistent with previously published data, and suggest that [90Y]-ibritumomab tiuxetan can be administered in patients with low tumor burden.5

"The positive results of the FIT study indicate the extent of benefit patients could receive from consolidation of their initial response, to their first line treatment for advanced follicular lymphoma with [90Y]-ibritumomab tiuxetan. The Cancer Reform Strategy sets out to build a world class cancer service in the NHS and as such, we look forward to a positive reception to these data and access for patients" commented Philip Ashman, Business Unit Head of Bayer Schering Pharma (BSP) Oncology Division in the UK.

Glossary

-Follicular lymphoma- A type of non-Hodgkin's Lymphoma (NHL)

-Indolent lymphoma- A slow growing lymphoma

-Aggressive lymphoma- A fast growing lymphoma

-Progression free survival- The time that a patient lives without evident tumour growth

-EMEA- European Medicines Agency. Responsible for the scientific evaluation of applications for European marketing authorisation for medicinal products (centralised procedure)

-Consolidation therapy- Is 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.

About [90Y]-ibritumomab tiuxetan

[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. [90Y]-ibritumomab tiuxetan combines the tumour-targeting ability of an anti-CD20 monoclonal antibody and the tumour-destroying ability of localized yttrium-90 beta-radiation, resulting in a significantly higher overall response rate compared to non-radiolabelled immunotherapy alone.6

The radiolabelled antibodies can specifically bind to the tumour, thus killing targeted and also neighbouring lymphoma cells, thus destroying the tumour through several layers of tumour cells. Rituximab pre-treatment is necessary to clear circulating B-cells, enabling [90Y]-ibritumomab tiuxetan to deliver radiation more specifically to the lymphomas.

About the FIT Study1:

Patients who responded to first line induction therapy with complete (including unconfirmed) or partial remission - CR/CRu or PR) were randomised to a single infusion of [90Y]-ibritumomab tiuxetan or no further treatment. In patients given [90Y]-ibritumomab tiuxetan the median PFS improved by 23.50 months to 37 months compared to 13.5 months for controls (p<0.0001; HR 0.463) and 77% moved from PR to CR. In total 87% of patients achieved CR or CRu.1

Bayer Schering Pharma AG has now filed a Type II Variation to the Marketing Authorisation of [90Y]-ibritumomab tiuxetan with the European Medicines Agency (EMEA), seeking a supplementary indication as first-line consolidation treatment for follicular lymphoma patients.

About Non-Hodgkins Lymphoma

There are over 20 different types of Non-Hodgkins Lymphoma7 with follicular lymphoma (FL) accounting for 1 in 4 of all cases.4 NHL is a cancer of the lymphatic system and is the 6th most common cancer in the UK.2,3 Every year around 10,000 people in the UK are diagnosed with NHL8 and it is estimated to cause around 4,450 deaths.9

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 http://www.bayerscheringpharma.co.uk

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

References:

1. FIT trial: [90Y]-ibritumomab tiuxetan (Zevalin) 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

2. CancerResearch UK accessed 12th December 2007.

3. Cancer help accessed 3rd December

4. Cancerbackup accessed 3rd December

5. Delaloye AB et al, Data presented at ASH, Atlanta, December 20075.

6. [90Y]-ibritumomab tiuxetan Summary of Product Characteristics

7. Cancerbackup accessed 3rd December

8. CancerResearch UK accessed 3rd December 2007

9. CancerResearch UK accessed 3rd December

Bayer Schering Pharma