Epratuzumab is a humanized monoclonal antibody targeting CD22 receptors on B lymphocytes. It is being evaluated for the treatment of non-Hodgkin’s lymphoma, and for autoimmune diseases such as systemic lupus erythematosus (SLE). The U.S. Food and Drug Administration has granted Epratuzumab Fast Track Product designation for the treatment of patients with lupus.
Epratuzumab has been licensed to UCB, S.A., for all autoimmune disease indications worldwide. We have retained the rights in oncology indications for which UCB has been granted a buy-in option. Encouraging top-line results from a UCB Phase IIb clinical trial for SLE have been reported in major medical conferences.
In oncology, Epratuzumab is being investigated by two National Cancer Institute-sponsored study groups: the Cancer and Leukemia Group B (CALGB) and the Children's Oncology Group (COG). At the 2010 annual meeting of the American Society of Hematology (ASH), the Cancer and Leukemia Group B reported promising results from a Phase II study combining Epratuzumab with rituximab for patients with previously untreated follicular lymphoma.
UCB has initiated a Phase III clinical trial program in lupus. Two multicenter, placebo-controlled, randomized, double-blind studies (EMBODY™ 1 and EMBODY™ 2), designed to evaluate the efficacy, safety, tolerability, and immunogenicity of Epratuzumab in patients with moderate to severe SLE, will each enroll 780 subjects and will last a maximum of 54 weeks.
For additional information about the EMBODY 1 trial, please see clinicaltrials.gov.
For additional information about the EMBODY 2 trial, please see clinicaltrials.gov.
The Cancer and Leukemia Group B has completed its study combining Epratuzumab and rituximab in patients with previously untreated follicular non-Hodgkin’s lymphoma. Results were presented at the 52nd Annual Meeting of ASH.
Although patient enrollment of the trial has concluded, information can be found at clinicaltrials.gov.
Acute Lymphoblastic Leukemia
The MARALL (monoclonal antibodies in patients with recurrent ALL) study is being conducted in the UK under sponsorship of Queen Mary, University of London. Information about this clinical research trial can be found at clinicaltrials.gov.
The GRAAL study group in France is conducting a multi-center trial entitled CHEPRALL study in patients with relapsed ALL. This trial combines chemotherapy with Epratuzumab. Information can be found at clinicaltrials.gov.
Combination biologic therapy as initial treatment for follicular lymphoma: Initial results from CALGB 50701 - a Phase II trial of extended induction Epratuzumab (anti-CD22) and rituximab (anti-CD20). B. Grant, J.P. Leonard, J.L. Johnson, L. Kostakoglu, E. Hsi, J.C. Byrd, J.A. Jones, S-H Jung, and B.D. Cheson. Blood (ASH Annual Meeting Abstracts), 116: Abstract 427, Nov 2010.
BILAG-measured improvement in moderately and severely affected body systems in patients with systemic lupus erythematosus (SLE) by Epratuzumab: Results from EMBLEM™, a phase IIb study. K.C. Kalunian, D.J. Wallace, M.A. Petri, F.A. Houssiau, M.C. Pike, B. Kilgallen, L. Kelley, and C.P. Gordon. Ann Rheum Dis. 69 (Suppl3):553, 2010.
Epratuzumab demonstrates clinically meaningful improvements in patients with moderate to severe systemic lupus erythematosus (SLE): Results from EMBLEM™, a phase IIb study. D.J. Wallace, K.C. Kalunian, M.A. Petri, V. Strand, B. Kilgallen, L. Kelley, and C.P. Gordon. Ann Rheum Dis. 69 (Suppl3):558, 2010.
Epratuzumab targeting of CD22 affects adhesion molecule expression and migration of B-cells in systemic lupus erythematosus. C. Daridon, D. Blassfeld, K. Reiter, H.E. Mei, C. Giesecke, D.M. Goldenberg, A, Hansen, A. Hostmann, D. Frölich, T. Dörner. Arthritis Res Ther. 12(6): R204, 2010. PMID: 21050432
Final results of NCCTG N0489: Epratuzumab and rituximab in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone chemotherapy (ER-CHOP) in patients with previously untreated diffuse large B-cell lymphoma. I. N. Micallef, M. J. Maurer, D. A. Nikcevich, M. W. Cannon, E. W. Schaefer, D. F. Moore, P. Kurtin, T. E. Witzig. J Clin Oncol 27:15s (suppl; abstr 8508), 2009. PMID: 21673350
Durable complete responses from therapy with combined Epratuzumab and rituximab: final results from an international multicenter, phase 2 study in recurrent, indolent, non-Hodgkin lymphoma. J.P. Leonard, S.J. Schuster, C. Emmanouilides, F. Couture, N. Teoh, W.A. Wegener, M. Coleman, D.M. Goldenberg. Cancer. 113(10): 2714-23, 2008. PMID 18853418
Differential effects of Epratuzumab on peripheral blood B cells of SLE patients versus normal controls. A.M. Jacobi, D.M. Goldenberg, F.T. Hiepe, A. Radbruch, G.R. Burmester, T. Dörner. Ann Rheum Dis. 67(4): 450-7, 2008. PMID 17673490
Initial clinical trial of Epratuzumab (humanized anti-CD22 antibody) for immunotherapy of systemic lupus erythematosus. T. Dörner, J. Kaufman, W.A. Wegener, N. Teoh, D.M. Goldenberg, G.R. Burmester. Arthritis Res Ther. 8(3): R74, 2006 PMID 16630358
Epratuzumab in the therapy of oncological and immunological diseases. D.M. Goldenberg. Expert Rev Anticancer Ther. 6(10): 1341-53, 2006. PMID 17069520
Epratuzumab (humanised anti-CD22 antibody) in autoimmune diseases. S.D. Steinfeld, P. Youinou. Expert Opin Biol Ther. 6(9): 943-9, 2006. PMID 16918261
Epratuzumab (humanised anti-CD22 antibody) in primary Sjögren's syndrome: an open-label phase I/II study. S.D. Steinfeld, L. Tant, G.R. Burmester, N.K. Teoh, W.A. Wegener, D.M. Goldenberg, O. Pradier. Arthritis Res Ther. 8(4): R129, 2006. PMID 16859536