FDANews

IMMUNOMEDICS REPORTS CLINICAL RESULTS OF EPRATUZMAB-RITUXIMAB COMBINATION

Immunomedics has announced the results of a trial conducted at eight centers in Europe testing the safety and response rates of its lead product, epratuzumab, in combination with rituximab in the treatment of patients with non-Hodgkin's lymphoma (NHL).

The multicenter trial enrolled a total of 32 patients with follicular or indolent NHL who received four consecutive weekly infusions of 360 mg/m2 of epratuzumab followed by the same weekly schedule of 375 mg/m2 rituximab. Prior to joining this study, 16 patients had received two or more chemotherapy regimens and eleven patients had rituximab therapy. Twenty patients, or 62 percent, achieved an objective response, including 25 percent with complete responses (CR/CRu) and 37 percent with partial responses. The median response duration was 16.5 months and the median time-to-progression was 11 months.