Phase I/II study of galiximab, an anti-CD80 antibody, for relapsed or refractory follicular lymphoma.

Abstract

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.

• Authors: Myron S Czuczman, Aron Thall, Thomas E Witzig, Julie M Vose, Anas Younes, Christos Emmanouilides, Thomas P Miller, Joseph O Moore, John P Leonard, Leo I Gordon, John Sweetenham, Baha Alkuzweny, Deborah M Finucane, Bryan R Leigh
• Journal: Journal of clinical oncology : official journal of the American Society of Clinical Oncology (J Clin Oncol) Vol. 23 Issue 19 Pg. 4390-8 (Jul 01 2005) ISSN: 0732-183X [Print] United States
• PMID: 15994148 (Publication Type: Clinical Trial, Clinical Trial, Phase I, Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Antibodies, Monoclonal
• Antineoplastic Agents
• B7-1 Antigen
• galiximab

Topics

• Adult
• Aged
• Antibodies, Monoclonal (adverse effects, therapeutic use)
• Antineoplastic Agents (therapeutic use)
• B7-1 Antigen (immunology)
• Female
• Humans
• Infections (complications)
• Lymphoma, Follicular (drug therapy)
• Male
• Middle Aged
• Neoplasm Recurrence, Local