Biogen Idec 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 in combination with a standard course of Rituxan. 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."
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