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Phase I/II Study of Galiximab, an Anti-CD80 Antibody, for Relapsed or Refractory Follicular Lymphoma

From the Roswell Park Cancer Institute, Buffalo, NY; Biogen Idec Inc, San Diego, CA; Mayo Clinic, Rochester, MN; University of Nebraska, Omaha, NE; M.D. Anderson Cancer Center, Houston, TX; University of California Los Angeles, Los Angeles, CA; Arizona Cancer Center, Tucson, AZ; Duke University, Durham, NC; Cornell Medical Center, New York, NY; Northwestern University, Chicago, IL; and University of Colorado Health Sciences Center, Aurora, CO

Address reprint requests to Myron S. Czuczman, MD, Roswell Park Cancer Institute, Elm and Carlton St, Buffalo, NY 14263-0001; e-mail: Myron.Czuczman{at}RoswellPark.org

PURPOSE: This multicenter, dose-escalation study evaluates the safety, pharmacokinetics, and efficacy of galiximab (anti-CD80 monoclonal antibody) in patients with relapsed or refractory follicular lymphoma.

PATIENTS AND METHODS: Patients had follicular lymphoma that had relapsed or failed to respond to primary therapy; the majority (90%) presented with stage III or IV disease. Four weekly intravenous infusions of galiximab were administered at doses of 125, 250, 375, or 500 mg/m².

RESULTS: Thirty-seven patients received galiximab treatment and were evaluated for safety; 35 were assessable for response. Antibody infusions were safe and well tolerated with no dose-limiting toxicities. A total of 22 (60%) of 37 patients experienced adverse events related to galiximab. All but one of the events were grade 1 or 2; the most common were fatigue, nausea, and headache. Cytopenias were rare; only one patient experienced anemia and febrile neutropenia, which were unrelated to galiximab and resolved after treatment. No patient developed antigaliximab antibody formation. The mean serum half-life ranged from 13 to 24 days. The overall response rate was 11% (two complete responses and two partial responses). Time to best response was delayed (months 3, 6, 9, and 12). Twelve patients (34%) maintained stable disease. Nearly half of all patients (49%) had a decrease in indicator lesions. Two responders remain on study without progression (22 and 24.4 months).

CONCLUSION: The favorable safety profile of galiximab and evidence of single-agent biologic activity and dose-dependent pharmacokinetics support further evaluation of galiximab as a treatment for follicular lymphoma, possibly in combination with other lymphoma therapies.

Supported by Biogen Idec Inc, San Diego, CA.

Authors' disclosures of potential conflicts of interest are found at the end of this article.

Presented in part at the 44th Annual Meeting of the American Society of Hematology, Philadelphia, PA, December 6-10, 2002; the 45th Annual Meeting of the American Society of Hematology, San Diego, CA, December 6-9, 2003; and the 39th Annual Meeting of the American Society of Clinical Oncology, Chicago, IL, May 31-June 3, 2003.

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