Immunomedics (IMMU) Reports ER-CHOP Produced Significant Overall Response in Patients with Newly Diagnosed Diffuse Large B-Cell Lymphoma
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Immunomedics, Inc. (Nasdaq: IMMU) today announced that adding epratuzumab to rituximab and combined cyclophosphamide, doxorubicin, vincristine, and prednisone chemotherapy (ER-CHOP) produced significant overall response including complete response in patients with newly diagnosed diffuse large B-cell lymphoma. Results of this final analysis were released by the Mayo Clinic, Rochester, MN, on May 14 as part of the 2009 Annual Meeting of the American Society of Clinical Oncology. Epratuzumab is Immunomedics' proprietary humanized anti-CD22 monoclonal antibody that has been studied in over 500 patients with non-Hodgkin's lymphoma.
The goal of this multicenter, open-labeled, Phase II study, led by Dr. Ivana Micallef of the Mayo Clinic, was to assess efficacy with event-free survival (EFS) at 12 months as the primary endpoint. Secondary endpoints include response rate, time to progression and safety.
Eighty eligible patients with previously untreated DLBCL received epratuzumab at 360 mg/m(2), followed by rituximab at 375 mg/m(2), and a standard dose of CHOP every 3 weeks for 6 cycles. Most patients (80%) had the advanced stages of the disease, 51% of the patients were in the high-risk category. Moreover, 73% of patients had an elevated blood level of lactate dehydrogenase, which indicates the presence of fast-growing tumors.
Overall, 94% of patients responded to ER-CHOP, including 71% complete responses and 23% partial responses. The 12-month and 24-month EFS rates were 79% and 69%, respectively. Patients were subdivided into two groups based on their International Prognostic Index (IPI) scores. A higher IPI score (3 to 5) predicts a patient having a poorer chance of being cured of their aggressive lymphoma, but this subgroup of patients responded equally well to ER-CHOP, producing a 67% EFS rate at 24 months as compared to 72% from the low-risk patients.
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