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

2007; Elsevier BV; Volume: 18; Issue: 7 Linguagem: Inglês

10.1093/annonc/mdm114

1569-8041

John P. Leonard, Jonathan W. Friedberg, Anas Younes, David C. Fisher, Leo I. Gordon, Joseph O. Moore, M. S. Czuczman, Thomas P. Miller, Patrick J. Stiff, Bruce D. Cheson, Andres Forero‐Torres, Nicole Chieffo, Byron McKinney, Deborah M. Finucane, A. Molina,

HER2/EGFR in Cancer Research

Abstract 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/m 2 ) and rituximab (375 mg/m 2 ). 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/m 2 ) 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.