BACKGROUND: Epratuzumab, an anti-CD22 humanized monoclonal antibody, has shown clinical activity as a single-agent (
METHODS: Forty-nine patients (23F/26M, median age: 61, elevated LDH: 25%, bone marrow involvement: 49%) with chemotherapy-relapsed or refractory follicular NHL (n=41) or small lymphocytic lymphoma (n=7) (as well as one enrolled patient with histological evidence of follicular and diffuse large B-cell lymphoma) were evaluated. Thirty-five (71%) were rituximab-naive, with the remainder having previously received and responded to then relapsed from rituximab (single agent or with chemotherapy). Patients received 360 mg/m2 IV of epratuzumab, followed by 375 mg/m2 IV of rituximab, weekly for 4 consecutive weeks.
RESULTS: As preliminarily reported (
CONCLUSIONS: Overall, this study confirms that the combination of epratuzumab and rituximab, in addition to being well tolerated, demonstrates promising anti-lymphoma activity for indolent NHL, and can result in durable complete remissions in a subset of patients. Further evaluation of this combination regimen as initial therapy for indolent NHL is planned (CALGB 50701), and in diffuse large B cell lymphoma (CHOP + epratuzumab + rituximab) is ongoing (NCCTG N0489).
Disclosure:Employment: Nick Teoh, William A Wegener, David M Goldenberg are employees of Immunomedics, Inc. Ownership Interests:; Nick Teoh, William A Wegener, David M Goldenberg have ownership interest in Immunomedics, Inc. Research Funding: John P Leonard, Stephen J Schuster, Christos Emmanoulides, and Felix Couture received research funding for this study from Amgen and Immunomedics, Inc. Off Label Use: Epratuzumab in combination with rituximab in NHL.