Originally published as JCO Early Release 10.1200/JCO.2006.05.6291 on July 24 2006

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Multicenter Phase II Trial of Immunotherapy With the Humanized Anti-CD22 Antibody, Epratuzumab, in Combination With Rituximab, in Refractory or Recurrent Non-Hodgkin's Lymphoma

Sandra J. Strauss, Frank Morschhauser, Juergen Rech, Roland Repp, Philippe Solal-Celigny, Pier L. Zinzani, Andreas Engert, Bernard Coiffier, Dieter F. Hoelzer, William A. Wegener, Nick K.W. Teoh, David M. Goldenberg, T. Andrew Lister

From the Cancer Research United Kingdom Medical Oncology Unit, St Bartholomew's Hospital, London, United Kingdom; Service des Maladies du Sang, Lille; Clinique Victor Hugo, Le Mans; Center Hospitalier Lyon-Sud, Lyon, France; University of Erlangen-Nuremberg, Erlangen; University Hospital, Koln; University Hospital, Frankfurt, Germany; Istituto di Ematologica Seragnoli, Bologna, Italy; Immunomedics Inc, Morris Plains; and the Garden State Cancer Center, Center for Molecular Medicine and Immunology, Belleville, New Jersey.

Address reprint requests to T. Andrew Lister, MD, Cancer Research United Kingdom Medical Oncology Unit, St Bartholomew's Hospital, West Smithfield, London, EC1A 7BE United Kingdom; e-mail: andrew.lister{at}cancer.org.uk

PURPOSE: A multicenter, single-arm study examining efficacy and toxicity of epratuzumab combined with rituximab was conducted in patients with recurrent or refractory non-Hodgkin's lymphoma.

PATIENTS AND METHODS: Sixty-five patients were enrolled; 34 patients with follicular lymphoma (FL), 15 patients with diffuse large B-cell lymphoma (DLBCL), and 16 patients with other lymphomas. The patients had received a median of two prior therapies (range, 1 to 4); 23% had received rituximab. Epratuzumab was given at 360 mg/m² intravenously over 60 minutes followed by infusion of 375 mg/m² rituximab, weekly for 4 consecutive weeks.

RESULTS: Combination therapy was well tolerated without greater toxicity than rituximab alone. The objective response (OR) rate was 47% (30 of 64) in assessable patients (46%; 30 of 65 in all patients), being highest in FL (64%; 21 of 33) and DLBCL (47%; seven of 15), and with 24% (eight of 33) and 33% (five of 15) achieving complete response (CR) or complete response unconfirmed (CRu) in these two groups, respectively. Two of six patients with marginal zone lymphoma responded to treatment (one CR). There was a trend for the response rates to be higher in patients with low prognostic index scores (statistically significant with respect to the Follicular Lymphoma International Prognostic Index score in FL patients), with 12 FL patients and three DLBCL patients in groups 0 to 1 having OR (CR/CRu) rates of 83% (33%) and 100% (100%), respectively. The median duration of response was 16 months for FL, with five patients currently progression free for 18 months to 30 months, and 6 months for DLBCL, with two patients currently progression free for 12 months and 18 months.

CONCLUSION: Epratuzumab combined with rituximab was well tolerated, demonstrating promising antilymphoma activity that warrants additional study.

published online ahead of print at www.jco.org on July 24, 2006.

Supported by Cancer Research United Kingdom and grants from Immunomedics Inc. T.A.L. and S.J.S. are supported by Cancer Research United Kingdom.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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