Oncology News
Galiximab - rituximab in previously untreated follicular lymphoma
By The Cancer and Leukemia Group B (CALGB)
Jun 7, 2008 - 6:26:31 PM

Lugano, Switzerland – June 7, 2008 – The Cancer and Leukemia Group B (CALGB) today announced data from a phase II clinical trial showing that 70 percent of patients with previously untreated follicular lymphoma responded to treatment with galiximab, an investigational anti-CD80 monoclonal antibody, when given in combination with rituximab. Of the 61 patients in the study, 44 percent achieved a complete response and 26 percent had a partial response. The data were presented at the 10th International Conference on Malignant Lymphoma (ICML).

The results of this open label study suggest that adding galiximab to rituximab may be a promising regimen for patients with follicular lymphoma (FL), a common type of non-Hodgkin lymphoma (NHL), and that further study is warranted. The objective of the CALGB-coordinated study is to determine the overall response rate (ORR) and time-to-progression of the disease after treatment with a combined regimen of galiximab and rituximab. At this point, however, it is too early to assess the time-to-progression endpoint.

"Most non-Hodgkin lymphoma patients receive rituximab, either as a single agent or in combination with chemotherapy," said Myron Czuczman, M.D., Roswell Park Cancer Institute, principal investigator of this study. "Now, 'biologic' agents are being studied in combination to assess the efficacy of dual antibody therapies as potential alternatives to chemotherapy-based regimens."

Patients enrolled in the study had been diagnosed with CD20-positive FL but had not received treatment for the disease. Study patients were given galiximab plus rituximab together once a week for four weeks and then every two months for the next eight months. This "extended induction" schedule was chosen based on results from an earlier Swiss (SAKK) trial using the same schedule with single-agent rituximab. Thirteen percent of patients reported a grade 3 adverse event; no grade 4 toxicities were associated with this combination immunotherapy regimen.

Galiximab is an anti-CD80 monoclonal antibody that has been studied as a single-agent in previously treated FL and in combination with rituximab against relapsed FL. The CD80 molecule is found on the surface of activated macrophages, dendritic cells and cells from various subtypes of NHL. Galiximab's potential mechanisms of action include Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and possible immunomodulatory effects on host effector cells affecting the tumor microenvironment.