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Ansell, S.M. et al.

Stephen M. Ansell, Thomas E. Witzig, David J. Inwards, Luis F. Porrata, Arnaud Ythier, Lee Ferrande, Ivan Nestorov, Todd Devries, Stacey R. Dillon, Diana Hausman, Anne J. Novak,

Phase I clinical study of atacicept in patients with relapsed and refractory B-cell non-Hodgkin's lymphoma.

PURPOSE: B-lymphocyte stimulator and a proliferation-inducing ligand regulate B-cell homeostasis and immunoglobulin production and are overexpressed in B-cell malignancies. Atacicept (TACI-Ig), a recombinant fusion protein that inhibits both B-lymphocyte stimulator and a proliferation-inducing ligand, may be a novel treatment for B-cell malignancies. EXPERIMENTAL DESIGN: A phase 1, open-label, dose-escalation study of atacicept in patients with relapsed or refractory B-cell lymphoma was done. Atacicept was given s.c. weekly for 5 weeks to sequential patient cohorts at doses of 2, 4, 7, or 10 mg/kg. Patients responding or with stable disease were eligible for treatment on an extension study for up to 24 weeks or until disease progression. RESULTS: All patients were heavily pretreated (median number of previous treatments, 5; range, 1-10), and four patients had previously received a stem cell transplant. Four patients were treated at the 2, 4, or 7 mg/kg dose levels, and three patients received 10 mg/kg of atacicept. Atacicept was well tolerated at all doses. Three adverse events with grade 3 severity were reported for one patient, including jaw pain, gastrointestinal hemorrhage, and sepsis; all were considered unrelated to atacicept. Pharmacokinetic results were nonlinear, and treatment with atacicept resulted in dose-dependent decreases in immunoglobulin concentrations. Two patients had stable disease at 8 weeks, entered the extension study, and received additional doses of atacicept with no safety or tolerability concerns. CONCLUSION: Atacicept at doses of up to 10 mg/kg was well tolerated and showed biological activity by decreasing immunoglobulin concentrations, although tumor responses were not observed.[1]

References

Phase I clinical study of atacicept in patients with relapsed and refractory B-cell non-Hodgkin's lymphoma. Ansell, S.M., Witzig, T.E., Inwards, D.J., Porrata, L.F., Ythier, A., Ferrande, L., Nestorov, I., Devries, T., Dillon, S.R., Hausman, D., Novak, A.J. Clin. Cancer Res. (2008) [Pubmed]

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