FDAnews
www.fdanews.com/articles/73343-data-show-combination-therapy-with-galiximab-rituxan-well-tolerated

Data Show Combination Therapy With Galiximab, Rituxan Well-Tolerated

June 14, 2005

Biogen Idec's Phase II clinical study demonstrated that galiximab may be used in combination with Rituxan 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 (rituximab) alone.

Combinations of biological agents, such as galiximab and Rituxan, are emerging as a novel treatment paradigm in oncology, the company said. 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 U.S. received escalating doses of galiximab in combination with a standard course of Rituxan. Sixty-four 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.