Amgen and Immunomedics Inc announced the closure of a phase 3 study of AMG 412, or Epratuzumab, in patients with low grade, follicular, B-cell non-Hodgkin's lymphoma (NHL) who failed other treatments including Rituximab (Rituxan, IDEC/Genentech).Since the study opened in 2001, new agents have been approved for this patient population, which adequately address the unmet medical need, and the particular indication being studied did not appear as commercially interesting as other applications.
Both companies stated, however, that they are encouraged by early results seen in multicenter trials of patients with indolent NHL treated with the combination of Epratuzumab and Rituximab, both the U.S. and Europe. The focus of this development program is to generate additional supportive data for the combination of Epratuzumab and Rituximab in the indolent NHL patient population and to work with cooperative study groups of the National Cancer Institute to evaluate the benefits of the combination of chemotherapy plus Epratuzumab and Rituximab in aggressive NHL patients.
"Since licensing this antibody, Amgen has learned much about the action and prospects of this novel therapeutic, and we believe we have now identified the best strategy for pursuing the use of Epratuzumab in the management of patients with non-Hodgkin's lymphoma, particularly in the current setting of therapy options for this disease.We will continue to work diligently with Immunomedics to pursue these studies and registration strategy," commented Roger Perlmutter, Executive Vice President of Research and Development at Amgen.
Amgen licensed Epratuzumab from Immunomedics for North America and Australia and is responsible for the development and commercialization in this territory.Immunomedics retained the rights to develop and commercialize the product in Europe, Japan and other countries.