A phase I/II study of galiximab (an anti-CD80 monoclonal antibody) in combination with rituximab for relapsed or refractory, follicular lymphoma

J. P. Leonard*, J. W. Friedberg, A. Younes, D. Fisher, L. I. Gordon, J. Moore, M. Czuczman, T. Miller, P. Stiff, B. D. Cheson, A. Forero-Torres, N. Chieffo, B. McKinney, D. Finucane, A. Molina

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

117 Scopus citations


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.

Original languageEnglish (US)
Pages (from-to)1216-1223
Number of pages8
JournalAnnals of Oncology
Issue number7
StatePublished - Jul 2007


  • CD80
  • Galiximab
  • Lymphoma
  • Monoclonal antibody
  • Rituximab

ASJC Scopus subject areas

  • Hematology
  • Oncology


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