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

Authors

  • John P. Leonard MD,

    Corresponding author
    1. Center for Lymphoma and Myeloma, Division of Hematology/Oncology, Weill Cornell Medical College and New York Presbyterian Hospital, New York, New York
    • Weill Cornell Medical College, 520 East 70th Street, New York, NY 10021===

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    • Fax: (212) 746-3844

  • Stephen J. Schuster MD,

    1. Division of Hematology/Oncology, Abramson Cancer Center, University of Pennsylvania, Philadelphia, Pennsylvania
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  • Christos Emmanouilides MD,

    1. Division of Hematology/Oncology, University of California-Los Angeles Medical Center, Los Angeles, California
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  • Felix Couture MD,

    1. Department of Medicine, University Hospital Center of Quebec, Montreal, Quebec, Canada
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  • Nick Teoh MD,

    1. Immunomedics, Inc., Morris Plains, New Jersey
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    • William A. Wegener, Nick Teoh, Morton Coleman, and David M. Goldenberg have employment, board membership, and/or stock ownership in Immunomedics, Inc.

  • William A. Wegener MD,

    1. Immunomedics, Inc., Morris Plains, New Jersey
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    • William A. Wegener, Nick Teoh, Morton Coleman, and David M. Goldenberg have employment, board membership, and/or stock ownership in Immunomedics, Inc.

  • Morton Coleman MD,

    1. Center for Lymphoma and Myeloma, Division of Hematology/Oncology, Weill Cornell Medical College and New York Presbyterian Hospital, New York, New York
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    • William A. Wegener, Nick Teoh, Morton Coleman, and David M. Goldenberg have employment, board membership, and/or stock ownership in Immunomedics, Inc.

  • David M. Goldenberg MD

    1. Immunomedics, Inc., Morris Plains, New Jersey
    2. Garden State Cancer Center, Belleville, New Jersey
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    • William A. Wegener, Nick Teoh, Morton Coleman, and David M. Goldenberg have employment, board membership, and/or stock ownership in Immunomedics, Inc.


  • Presented in abstract form at the 49th Annual Meeting of the American Society of Hematology, Atlanta, Georgia, December 8-11, 2007.

  • J.P.L., W.A.W., and D.M.G. were responsible for study design; Immunomedics, Inc. (W.A.W.) provided epratuzumab; J.P.L., S.J.S., C.E., F.C., and M.C. provided patients; W.A.W. and N.T. collected and assembled data; J.P.L., W.A.W., and N.T. provided data analysis; J.P.L., W.A.W., M.C., and D.M.G. interpreted the data; J.P.L., W.A.W., N.T., and D.M.G. wrote the article; and all authors reviewed and approved the article.

Abstract

BACKGROUND.

In this international, multicenter trial, the authors evaluated rituximab (anti-CD20) plus epratuzumab (anti-CD22) in patients with postchemotherapy relapsed/refractory, indolent non-Hodgkin lymphoma (NHL), including long-term efficacy.

METHODS.

Forty-nine patients with follicular NHL (FL) (N = 41) or small lymphocytic lymphoma (SLL) (N = 7) received intravenous epratuzumab 360 mg/m2 and then intravenous rituximab 375 mg/m2 weekly ×4. The regimen was tolerated well.

RESULTS.

Twenty-two of 41 patients with FL (54%) had an objective response (OR), including 10 (24%) complete responses (CR) (CR/unconfirmed CR [CRu]), whereas 4 of 7 patients with SLL (57%) had ORs, including 3 (43%) with CR/CRu. Rituximab-naive patients (N = 34) had an OR rate of 50% (26% CR/CRu rate), whereas patients who previously responded to rituximab (N = 14) had an OR rate of 64% (29% CR/CRu rate). An OR rate of 85% was observed in patients with FL who had Follicular Lymphoma International Prognostic Index (FLIPI) risk scores of 0 or 1 (N = 13), whereas 28 patients with intermediate or high-risk FLIPI scores (≥2) had an OR rate of 39% (18% CR/CRu rate). In patients with FL, the median response duration was 13.4 months, and that duration increased to 29.1 months for 10 patients who had a CR/CRu, including 4 patients who had durable responses with remissions that continued for >4 years. In patients with SLL, the median response duration was 20 months, including 1 patient who had a response that continued for >3 years.

CONCLUSIONS.

The combination of epratuzumab and rituximab induced durable responses in patients with recurrent, indolent NHL. Cancer 2008. © 2008 American Cancer Society.

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