VANCOUVER, British Columbia, June 11, 2013 (GLOBE NEWSWIRE) -- Immunomedics, Inc. (Nasdaq:IMMU),a biopharmaceutical company primarily focused on the development of monoclonal antibody-based products for the targeted treatment of cancer, autoimmune and other serious diseases, today reported that epratuzumab labeled with the radioisotope, yttrium-90 ( 90Y), given in small doses in combination with veltuzumab is therapeutically active in patients with aggressive non-Hodgkin lymphoma (NHL). Results from this multicenter study were presented by Michael B. Tomblyn, MD, of H. Lee Moffitt Cancer Center in Tampa, FL. Despite the advent of immunotherapy with anti-CD20 antibody for B-cell malignancies, aggressive NHLs remain a challenge, requiring the addition of chemotherapy. An attractive prospect for NHL therapy is to combine immunotherapy with radioimmunotherapy (RIT) targeting a different B-cell antigen. Since CD20 and CD22 are distinct antigens, anti-CD20 antibodies should not cross-block anti-CD22 RIT in such a treatment regimen. In a previous clinical study, anti-CD22 RIT with 90Y-epratuzumab has produced results that are comparable to other interventions. 1 Moreover, given that the anti-CD20 veltuzumab also compared well to published results with rituximab, 2,3 the Company is conducting a Phase I/II study to evaluate the potential of 90Y-epratuzumab combined with veltuzumab in patients with aggressive NHL. Results from 18 patients with various types of aggressive NHL who had failed 1 or more prior standard therapies were reported at the medical conference. Based upon prior study of 90Y-epratuzumab given alone in mostly indolent NHL patients, 2 infusions at 15 mCi/m 2 were the initial dosage. However, 90Y-doses were lowered due to dose-limiting thombocytopenia and neutropenia, although most counts recovered within 1 – 8 weeks with no cases of transfusion-dependent thrombocytopenia. Maximum tolerated dose was determined as 2 infusions at 6 mCi/m 2. One patient withdrew before evaluation due to a severe adverse event. The overall objective response rate among 17 patients who have had treatment response assessments was 53% (9/17), with 2 patients (17%) reporting a complete response (CR). One of the CR patients improved from a partial response (PR) after being retreated with 90Y-epratuzumab. The other complete responder is continuing at 18 months. The combination is active in all NHL subgroups and across all 90Y-dose levels tested and IPI scores. At the maximum tolerated dose of 6 mCi/m 2 x 2, 5 of 6 patients (83%) reported a PR or better. "We are very encouraged by these early efficacy results, especially in light of the current low dose of 90Y," remarked Cynthia L. Sullivan, President and Chief Executive Officer of Immunomedics. "The Phase II part of this study is now underway," Ms. Sullivan added. This study was supported in part by Award Number R44CA139668 from the National Cancer Institute. The content is solely the responsibility of the Company and does not necessarily represent the official views of the National Cancer Institute or the National Institutes of Health.
|Subgroups||Number of Patients||Objective Response (%)||Complete Response (N)||Partial Response (N)||Stable Disease (N)|
|Diffuse large B-cell lymphoma||8||50%||2||2||1|
|Mantle cell lymphoma||5||20%||0||1||3|
|Transformed follicular lymphoma||4||100%||0||4||0|
|90Y Dose Level|
|12 + 15 mCi/m 2||5||60%||1||2||1|
|9 mCi/m 2||6||17%||0||1||3|
|6 mCi/m 2||6||83%||1||4||0|
|International Prognostic Index Scores|
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- Morschhauser F,. Leonard J.P., Fayad L., Coiffier B., Petillon M.O., Coleman M., Schuster S.J., Dyer M.J., Horne H., Teoh N., Wegener W.A., Goldenberg D.M. Humanized anti-CD20 antibody, veltuzumab, in refractory/recurrent non-Hodgkin's lymphoma: phase I/II results. J Clin Oncol. 2009 Jul 10;27(20):3346-53. doi: 10.1200/JCO.2008.19.9117. Epub 2009 May 18.
- Negrea G.O., Elstrom R., Allen S.L., Rai K.R., Abbasi R.M., Farber C.M., Teoh N., Horne H., Wegener W.A., Goldenberg D.M. Subcutaneous injections of low-dose veltuzumab (humanized anti-CD20 antibody) are safe and active in patients with indolent non-Hodgkin's lymphoma. Haematologica. 2011 Apr;96(4):567-73. doi: 10.3324/haematol.2010.037390. Epub 2010 Dec 20.
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