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
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.
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
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.