The FINANCIAL -- Zevalin ([90Y]-ibritumomab tiuxetan) consolidation therapy significantly improves progression-free survival (PFS) rates in advanced stage follicular lymphoma (FL), according to major new data presented at the 49th Annual Meeting of the American Society of Hematology.
According to Bayer, presented to the scientific community for the first time, results from the Zevalin First-Line Indolent Trial (FIT) showed a median PFS of 37 months with Zevalin vs. 13.5 months in the control arm (p<0.0001). Bayer Schering Pharma AG has exclusive rights to Zevalin in all countries of the world except the United States of America.
"Subgroup analysis showed a median PFS of 29.7 months vs. 6.3 months (p<0.0001) for patients in partial remission (PR) following induction therapy, and 54.6 months vs. 29.9 months (p=0.01) for patients in complete remission (CR), respectively." Bayer reports.
Professor Anton Hagenbeek, FIT lead investigator, Academic Medical Centre, Amsterdam, the Netherlands, commented, "I am particularly impressed with the observation that with one single infusion of Zevalin, we have achieved prolongation of Progression-Free Survival by two years, with a favorable toxicity profile. These results help us to understand how we can improve patients’ prospects step by step, and show that radioimmunotherapy is the most effective single agent in the treatment of follicular lymphoma.”
"Further, after Zevalin consolidation 77% of patients in PR after induction therapy converted to CR. In total, 87% of Zevalin patients responded, with 76% in CR and 11% in unconfirmed complete remission (CRu)." Bayer adds.
“We are very excited about the FIT results as they demonstrate that Zevalin consolidation therapy provides a clear improvement for patients in the quality of their response and therefore, in their remission period”, said Dr. Kemal Malik, Head of Global Development, Bayer Schering Pharma AG. “It is our goal to provide highly effective forms of treatments to patients as early as possible. Therefore, the positive FIT results are very important for the clinical practice.”
Bayer announces, that measuring remission response at a molecular level, Zevalin treatment resulted in 90% of patients converting from RQ-PCR positive to negative status (Real-time Quantitative Polymerase Chain Reaction), which was was associated with a significant prolongation of PFS compared with the control arm.
"FIT also investigated the impact of Zevalin consolidation therapy on health-related quality of life (QoL). No differences were observed in health-related QoL parameters between the two trial arms. The data are therefore encouraging in suggesting that in patients with advanced-stage FL responsive to first-line therapy, Zevalin consolidation treatment does not adversely impact health-related QoL." Bayer reports.
According to Bayer, Zevalin patients’ radiation exposure was also analysed, in patients for whom dosimetry data were available. The results confirmed that radiation exposure with Zevalin treatment is within safe limits to normal organs and that hematologic toxicity does not correlate with RM radiation dose estimates. These findings are consistent with previously published data, and suggest that Zevalin is safely administered in patients with low tumor burden.
About the FIT study
The Zevalin FIT study (First-line Indolent Trial) is a multinational, randomized, Phase III 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 standard first-line chemotherapy regimens. The objective of the FIT study is the evaluation of benefit and safety of consolidation with Zevalin after first-line therapy in follicular lymphoma patients, one of the most common types of Non Hodgkin’s Lymphoma (NHL).
About Zevalin – 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 patient’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 Agency for the Evaluation of Medicinal Products (EMEA), seeking a supplementary indication as first-line consolidation treatment for follicular lymphoma patients.
About Zevalin – the immunotherapy with yttrium-90
Zevalin has been approved for adult patients with rituximab-relapsed or refractory CD20-positive follicular B-cell non-Hodgkin’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-radiolabeled immunotherapy alone.
The radiolabeled antibodies can specifically bind to the tumor, thus killing targeted and also neighboring 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 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).
Non-Hodgkin’s lymphomas can be divided into two general clinical categories: indolent lymphomas, mainly typified as follicular lymphomas, which tend to grow relatively slowly, and aggressive lymphomas, mainly typified as diffuse large B-cell lymphoma (DLBCL), which grow more rapidly. Follicular lymphoma is one of the most common types of indolent NHL, accounting for 70% of all indolent cases. The overall prevalence of NHL in the European Union is approximately 230,000, with an annual incidence of about 70,000. Approximately 18,500 new cases of FL are diagnosed annually in the USA. It is a long-lasting disease and is difficult to treat.
About Bayer Schering Pharma
The Bayer Group is a global enterprise with core competencies in the fields of healthcare, nutrition and high-tech materials. Bayer HealthCare, a subsidiary of Bayer AG, is one of the world’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 HealthCare’s aim is to discover and manufacture products that will improve human and animal health worldwide.
Bayer Schering Pharma is one of 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.