Epratuzumab-rituximab combination therapy effective against previously untreated follicular lymphoma

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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 announced that combination therapy with epratuzumab and rituximab was effective, with durable complete responses in one-third of evaluable patients, and was very well tolerated by patients with previously untreated follicular lymphoma (FL).

Epratuzumab is Immunomedics' proprietary humanized anti-CD22 monoclonal antibody that has shown single agent activity in FL, and when used in combination with rituximab, produced durable, complete responses in patients with relapsed or refractory indolent non-Hodgkin's lymphoma (NHL). Rituximab is also effective as single agent therapy for FL, and has extended remissions and survival when combined with chemotherapy.  The goal of this multicenter, open-label, Phase II trial was to evaluate the combination of epratuzumab and rituximab without chemotherapy in treatment-naive FL patients.

Sixty evaluable FL patients were enrolled by the NCI-sponsored study group, CALGB, to receive intravenous epratuzumab and rituximab at 360 mg/m2 and 375 mg/m2, respectively. Rituximab was administered weekly for 4 weeks, then every 8 weeks for 4 additional doses for a total of 8 doses over 9 months. Epratuzumab was given two days before the first rituximab dose to assess toxicity.  From week 2 on, epratuzumab was given before rituximab on the same day for a total of 8 doses over 9 months.

Patients were categorized into three groups with good, intermediate or poor prognosis, based on their Follicular Lymphoma International Prognostic Index (FLIPI) scores.  A high FLIPI score predicts a patient having a poorer chance of having a treatment response.  FLIPI scores at study entry were 13 (22%) low; 28 (47.5%) intermediate; and 18 (30.5%) high. 

Results from 57 evaluable patients were reported at the meeting. Overall, the two antibodies produced an objective response rate of 84.2% with 20 complete responses (CRs) (33.3%), 30 partial responses (PRs) (50.9%) and 8 patients (13.6%) having stable disease. The mean time to CR was 9 months. Four patients progressed after a period of stable disease, and 23 of the 30 patients who achieved PR remain in response. All 20 CRs also remain in remission at the time of reporting, with a median follow-up of 1.4 years. The CR rate in low risk patients was 31%, 44% in intermediate risk and 18% in high risk patients.

"This is the 4th multicenter trial indicating high efficacy of epratuzumab when combined with rituximab," commented Cynthia L. Sullivan, President and Chief Executive Officer of Immunomedics, Inc.

SOURCE Immunomedics, Inc.

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