Annals of Oncology Advance Access originally published online on April 29, 2007
Annals of Oncology 2007 18(7):1216-1223; doi:10.1093/annonc/mdm114
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© 2007 European Society for Medical Oncology
hematologic malignancies |
A phase I/II study of galiximab (an anti-CD80 monoclonal antibody) in combination with rituximab for relapsed or refractory, follicular lymphoma
1 Division of Hematology/Oncology, Weill Medical College of Cornell University and NewYork-Presbyterian Hospital, New York, NY
2 Lymphoma Clinical Research, James P. Wilmot Cancer Center, University of Rochester, Rochester, NY
3 Division of Cancer Medicine Department of Lymphoma and Myeloma, M.D. Anderson Cancer Center, Houston, TX
4 Department of Hematologic Malignancies, Dana Farber Cancer Institute, Boston, MA
5 Division of Hematology/Oncology, Northwestern University, Chicago, IL
6 Division of Hematology—Oncology, Duke University, Durham, NC
7 Departments of Hematologic Oncology and Bone Marrow Transplantation, Roswell Park Cancer Institute, Buffalo, NY
8 Section of Hematology/Oncology, University of Arizona, Tucson, AZ
9 Division of Hematology/Oncology, Loyola University Medical Center, Chicago, IL
10 Department of Hematology, Georgetown University Hospital, Washington, DC
11 Division of Hematology/Oncology, University of Alabama at Birmingham, Birmingham, AL
12 Department of Hematology/Oncology - Medical Research
13 Department of Biostatistics
14 Department of Medical Writing, Biogen Idec Inc., San Diego, CA, USA
* Correspondence to: Dr J. P. Leonard, Weill Medical College of Cornell University and NewYork-Presbyterian Hospital, Starr Building, Room 340, 520 East 70th Street, New York, NY 10021 USA. Tel: +1 212-746-2932; Fax: +1 212-746-3844; E-mail: jpleonar{at}med.cornell.edu
Background: Galiximab is a monoclonal antibody that targets CD80, a costimulatory molecule constitutively expressed on follicular and other lymphomas. Modest single-agent clinical activity and tolerability were demonstrated in a phase I study in relapsed or refractory, follicular non-Hodgkin's lymphoma (NHL). A phase I/II study was conducted to evaluate galiximab in combination with a standard course of rituximab. Safety, pharmacokinetics, and efficacy were evaluated.
Patients and methods: Patients with follicular NHL who had relapsed or failed primary therapy were enrolled. Rituximab-refractory patients (no response or a response with time to progression <6 months) were excluded. Patients received 4 weekly i.v. infusions of galiximab (125, 250, 375, or 500 mg/m2) and rituximab (375 mg/m2). International Workshop Response Criteria (IWRC) were used to evaluate response.
Results: Seventy-three patients received treatment. All had received at least one prior lymphoma therapy; 40% were rituximab naive. Infusions were delivered in an outpatient setting and were well tolerated. The most common study-related adverse events (AE) were lymphopenia, leukopenia, neutropenia, fatigue, and chills. The overall response rate at the recommended phase II dose of galiximab (500 mg/m2) was 66%: 19% complete response, 14% unconfirmed complete response, and 33% partial response. The median progression free survival was 12.1 months. Combination therapy did not appear to alter pharmacokinetics.
Conclusion: These results indicate that galiximab can be safely combined with a standard course of rituximab. This doublet biologic approach offers the potential to avoid or delay chemotherapy or to integrate with other lymphoma therapies. A phase III, randomized study evaluating clinical benefit of rituximab versus the combination has been initiated.
Key words: galiximab, lymphoma, monoclonal antibody, rituximab, CD80
These authors contributed equally to this work and share first authorship. Received for publication November 7, 2006. Revision received February 21, 2007. Accepted for publication February 22, 2007.
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