ZevalinÂ® Phase 3 Multi-National Trial Meets Primary Endpoint / Presentation at 49th Annual Meeting of the American Society of Hematology
BERLIN, November 12, 2007 â€“ The major multinational, randomized Phase 3 First-Line Indolent Trial (FIT), with Zevalin ([90Y]-ibritumomab tiuxetan), has met its primary endpoint. The trial demonstrated an improvement in progression-free survival (PFS) in patients with advanced follicular lymphoma (FL) treated with Zevalin as first-line consolidation therapy.
In the trial, patients received either Zevalin or no further treatment after at least a partial response to initial induction treatment. Patients in the Zevalin study arm experienced longer PFS compared to those patients in the observation arm.
â€œDespite improvements in recent years, follicular lymphoma is still challenging to treat and many patients experience a relapse following treatment. An important goal of consolidation therapy is to ensure that, for patients who respond to initial induction therapy, the quality of their response is improved and therefore, their remission period is long-lastingâ€, said Dr. Kemal Malik, Head of Global Development, Bayer Schering Pharma AG. â€œThe aim of FIT was to see â€” in a randomized, prospective clinical trial setting â€” if a single therapeutic dose of Zevalin as first-line consolidation therapy could achieve this important goal.â€
Full results from the Phase 3 FIT trial will be presented during the 49th Annual Meeting of the American Society of Hematology (ASH) in the Georgia World Congress Center in Atlanta, Georgia, from December 8 to 11, 2007:
â€¢ [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).
Abstract# 643. Oral presentation: Monday December 10, 15.30-17.00 EST, Room A411-A412
Copies of abstracts are available and can be viewed online at the ASH website:
About the FIT study
The Zevalin FIT trial (First-line Indolent Trial) is a multinational, randomized Phase 3 trial to investigate Zevalin as first-line consolidation therapy, given as a single therapeutic dose in patients with advanced (stage III or IV) follicular lymphoma who achieve at least a partial remission (PR) or complete remission (CR) after receiving induction chemotherapy regimens. The objective of the FIT study is the evaluation of benefit and safety of consolidation with Zevalin after first-line therapy in patients with follicular lymphoma, one of the most common types of non-Hodgkin lymphoma (NHL).
About Zevalin â€” the immunotherapy with yttrium-90 power
Zevalin has been approved for adult patients with rituximab-relapsed or refractory CD20-positive follicular B-cell non-Hodgkinâ€™s lymphoma in Europe since 2004. Zevalin ([90Y]-ibritumomab tiuxetan) combines the tumor-targeting ability of an anti-CD20 monoclonal antibody and the tumor-destroying power of localized yttrium-90 radiation, resulting in an efficacy superior to non-radiolabelled immunotherapy alone.
The radiolabelled antibodies can specifically bind to the tumor, thus killing targeted and also neighbouring lymphoma cells, thus destroying the tumor through several layers of tumor cells. The treatment ensures a high bio-availability at tumor sites and prevents the radioactivity from being distributed through the body by circulating lymphocytes.
About Zevalin â€“ First-line Consolidation Therapy
Consolidation therapy is a treatment regimen given after a patient responds to initial first-line induction therapy (e.g. chemotherapy, immunochemotherapy). The aim of consolidation therapy is to rapidly improve the quality of a patientâ€™s response, thereby extending the response duration.
Bayer Schering Pharma AG has now filed a Type II Variation to the Marketing Authorisation of Zevalin with the European Medicines Agency (EMEA), seeking a supplementary indication as first-line consolidation treatment for follicular lymphoma patients.
About non-Hodgkin lymphoma (NHL)
Non-Hodgkin lymphoma is a type of malignant disease that occurs within the lymphatic system. NHL is the fifth most common cancer after breast, prostate, lung, and colon cancer. It originates from lymphocytes, a type of white blood cells, which can be divided into two main types, B lymphocytes and T lymphocytes (also called B-cells or T-cells). In adults, approximately 85% of NHL cases are of B-cell origin.
The overall prevalence of NHL in the European Union is approximately 230,000, with an annual incidence of about 70,000. This incidence is currently increasing in Europe by four percent per year. Follicular lymphoma is one of the most common types of non-Hodgkin lymphomas, accounting for 30-40% of NHL cases: it is a long-lasting disease and is difficult to treat.
Non-Hodgkinâ€™s lymphomas can be divided into two general clinical categories: indolent lymphomas, mainly typified as follicular lymphoma, which tend to grow relatively slow, and aggressive lymphomas, mainly typified as diffuse large B-cell lymphoma (DLBCL), which grow more rapidly.
About Bayer Schering Pharma
The Bayer Group is a global enterprise with core competencies in the fields of health care, nutrition and high-tech materials. Bayer HealthCare, a subsidiary of Bayer AG, is one of the worldâ€™s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Diabetes Care and Pharmaceuticals divisions. The pharmaceuticals business operates under the name Bayer Schering Pharma AG. Bayer HealthCareâ€™s aim is to discover and manufacture products that will improve human and animal health worldwide. Find more information at www.bayerhealthcare.com.
Bayer Schering Pharma is a worldwide leading specialty pharmaceutical company. Its research and business activities are focused on the following areas: Diagnostic Imaging, Hematology/Cardiology, Oncology, Primary Care, Specialized Therapeutics and Women's Healthcare. With innovative products, Bayer Schering Pharma aims for leading positions in specialized markets worldwide. Using new ideas, Bayer Schering Pharma aims to make a contribution to medical progress and strives to improve the quality of life. Find more information at www.bayerscheringpharma.de.
This news release contains forward-looking statements based on current assumptions and forecasts made by Bayer Group management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in our annual and interim reports to the Frankfurt Stock Exchange and in our reports filed with the U.S. Securities and Exchange Commission (including our Form 20-F). The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.