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Phase II Data Show Combination Biological Therapy With Galiximab and RITUXAN is Well-Tolerated and May Extend Event-Free Survival in Patients With Relapsed or Refractory, Follicular Lymphoma

Posted on: Tuesday, 14 June 2005, 12:00 CDT

Biogen Idec (NASDAQ: BIIB) today announced that a Phase II clinical study demonstrated that galiximab may be used in combination with RITUXAN(R) (rituximab), and the combination may prolong event-free survival (EFS) in patients with relapsed or refractory, follicular non-Hodgkin's lymphoma (NHL) when compared to previous results with RITUXAN monotherapy. Side effects of the combination are similar to treatment with RITUXAN alone.

Combinations of biological agents, such as galiximab and RITUXAN, are emerging as a novel treatment paradigm in oncology. While current chemotherapy treatments attack both malignant and healthy cells, galiximab and RITUXAN specifically target CD80 and CD20, respectively, which are found on normal and malignant B cells, but not on other tissues in the body. As a result, targeted therapies such as these may have the potential to improve existing treatments.

In this dose-escalation study, 73 patients from the United States received escalating doses of galiximab (125, 250, 375, or 500 mg/m2 weekly x 4) in combination with a standard course of RITUXAN (375 mg/m2 weekly x 4). Sixty-four (64) patients were treated at 500 mg/m2 and the results were encouraging. The combination produced a 64 percent overall response rate including 31 percent achieving a complete response (confirmed and unconfirmed) and 33 percent achieving a partial response. The combination use demonstrated an increase in EFS without a significant increase in toxicity compared to reported results with single-agent RITUXAN. The median EFS for patients treated with galiximab plus RITUXAN was 12.1 months, longer than that observed in previous trials of single-agent RITUXAN in a similar population of patients with follicular NHL. These data were presented during an oral presentation at the International Conference on Malignant Lymphoma in Lugano, Switzerland, June 11, 2005.

"This is one of the first studies to use a combination of monoclonal antibodies. These study results show promise for the treatment of NHL, and the future of cancer treatment," said Burt Adelman, M.D., Executive Vice President of Development for Biogen Idec. "Treatments such as galiximab plus RITUXAN could pave the way for more successful and more targeted cancer treatments. We look forward to seeing what future galiximab studies reveal."

About Galiximab

Galiximab is a PRIMATIZED(R) monoclonal antibody that targets CD80 on the B cell surface and has shown anti-tumor effects in preclinical studies. In a Phase I study, 37 patients with relapsed or refractory, follicular NHL were treated with single-agent galiximab. Galiximab treatment reduced tumors in 49 percent of patients, and 11 percent of patients had enough reduction to be classified as having partial or complete response. In responders, EFS ranged from 11.2 - 31 months. Future directions include randomized studies to further define the uses of galiximab, and combination studies with chemotherapy.

Adverse Events

Adverse events (AEs) of possible, probable, or unknown relationship to the study treatment occurred in 95 percent of patients treated in the highest dose group. These AEs were primarily grade one or two and included cytopenias, fatigue, chills and nausea. No anti-galiximab antibody formation was detected.

About NHL

Adult NHL is a disease in which malignant (cancer) cells form in the lymph system, one of the places white blood cells are formed. The lymph system is part of the immune system and is made up of lymph, lymph vessels, lymph nodes, the spleen, the thymus, tonsils and bone marrow. Cancer develops when the division and growth of cells goes unchecked, or due to a deregulation in cell death. As a result, cells continue to divide and form a lump or tumor.

About Biogen Idec

Biogen Idec creates new standards of care in oncology, neurology and immunology. As a global leader in the development, manufacturing, and commercialization of novel therapies, Biogen Idec transforms scientific discoveries into advances in human healthcare. For product labeling, press releases and additional information about the company, please visit www.biogenidec.com.

Source: Business Wire

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