Study Showed Epratuzumab In Combination With Rituximab And Chemotherapy Is Safe, Tolerable, And Active In Aggressive Lymphoma

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BlankStudy Showed Epratuzumab In Combination With Rituximab And Chemotherapy Is

Safe, Tolerable, And Active In Aggressive Lymphoma

05 Dec 2006

Immunomedics, Inc. (Nasdaq: IMMU), a biopharmaceutical company focused on

developing monoclonal antibodies, today reported that adding epratuzumab to

rituximab and combined cyclophosphamide, doxorubicin, vincristine, and

prednisone chemotherapy (ER-CHOP) to treat patients with newly diagnosed diffuse

large B-cell lymphoma (DLBCL) produced promising results. This study was

published in an on-line article in Cancer.

Fifteen patients with previously untreated DLBCL were enrolled in this Phase II

study led by Dr. Ivana Micallef at the Division of Hematology, Department of

Internal Medicine, Mayo Clinic College of Medicine, Rochester, MN. Thirteen of

15 patients responded (87%), including 10 complete responses (67%) and 3 partial

responses (20%). At a median follow-up of 30 months, 13 of 15 patients remained

alive. The 1-year progression-free survival (PFS) and overall survival (OS)

rates were 93% and 100%, respectively, and the 2-year PFS and OS rates were 86%

and 86%, respectively.

" To our knowledge, this is the first study to combine epratuzumab with

chemotherapy. The results from this pilot study showed that ER-CHOP is a safe

and effective regimen for the treatment of patients with newly diagnosed DLBCL, "

remarked Dr. Ivana Micallef, senior author. " These encouraging initial results

have led us to conduct a Phase II multicenter study using ER-CHOP for newly

diagnosed DLBCL under the auspices of the North Central Cancer Treatment Group,

funded by the National Cancer Institute. The new trial is progressing very well

in accrual, " she added.

Patients received epratuzumab at 360 mg/m2, followed by rituximab at 375 mg/m2,

and a standard dose of CHOP every 3 weeks for 6 to 8 cycles. Although, grade 3

or 4 neutropenia was observed in 14 patients (93%), or in 28 of 92 cycles (30%),

only 3 patients developed grade 3 or more infection or fever. Eleven patients

(73%) required dose reductions mainly secondary to grade 4 neutropenia. No grade

3 antibody infusion-related toxicity was reported.

Authored by I.N.M. Micallef, B.S. Kahl, M.J. Maurer, A. Dogan, S.M. Ansell, S.M.

Ansell, J.P. Colgan, S. Geyer, D.J. Inwards, W.L. White and T.M. Habermann, the

article entitled " A pilot study of epratuzumab and rituximab in combination with

cyclophosphamide, doxorubicin, vincristine, and prednisone chemotherapy in

patients with previously untreated, diffuse large B-cell lymphoma " can be

accessed at http://www3.interscience.wiley.com/cgi-

bin/abstract/113456987/ABSTRACT.

Epratuzumab is being studied in two NCI-sponsored clinical trials involving the

Children's Oncology Group and the North Cancer Center Treatment Group, and is

anticipated to expand to other study group trials in the future as the safety

and efficacy results in such lymphoma and leukemia trials are reported. Two

prior trials published in the Journal of Clinical Oncology in 2005 and 2006

showed that epratuzumab can be combined with rituximab safely, with a suggestion

of improved complete and durable response rates in patients with indolent and

aggressive NHL types.