A Phase II clinical study demonstrated that Galiximab may be used in combination with Rituximab ( 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 Rituximab monotherapy. Side effects of the combination are similar to treatment with Rituximab 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 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.
Galiximab is a 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.
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.
Source: International Conference on Malignant Lymphoma, 2005