8:32AM Immunomedics reports that epratuzumab labeled with the radioisotope, yttrium-90 (90Y), given in small doses in combination with veltuzumab is therapeutically active in patients with aggressive non-Hodgkin lymphoma (IMMU) 4.29 : Co reported that epratuzumab labeled with the radioisotope, yttrium-90, given in small doses in combination with veltuzumab is therapeutically active in patients with aggressive non-Hodgkin lymphoma. Results from this multicenter study were presented by Michael B. Tomblyn, MD, of H. Lee Moffitt Cancer Center in Tampa, FL.
In a previous clinical study, anti-CD22 RIT with 90Y-epratuzumab has produced results that are comparable to other interventions. Moreover, given that the anti-CD20 veltuzumab also compared well to published results with rituximab,2,3 the Company is conducting a Phase I/II study to evaluate the potential of 90Y-epratuzumab combined with veltuzumab in patients with aggressive NHL. Results from 18 patients with various types of aggressive NHL who had failed 1 or more prior standard therapies were reported at the medical conference.
Based upon prior study of 90Y-epratuzumab given alone in mostly indolent NHL patients, 2 infusions at 15 mCi/m2 were the initial dosage. However, 90Y-doses were lowered due to dose-limiting thombocytopenia and neutropenia, although most counts recovered within 1 -- 8 weeks with no cases of transfusion-dependent thrombocytopenia. Maximum tolerated dose was determined as 2 infusions at 6 mCi/m2. One patient withdrew before evaluation due to a severe adverse event.
The overall objective response rate among 17 patients who have had treatment response assessments was 53% (9/17), with 2 patients (17%) reporting a complete response (CR). One of the CR patients improved from a partial response (PR) after being retreated with 90Y-epratuzumab. The other complete responder is continuing at 18 months. The combination is active in all NHL subgroups and across all 90Y-dose levels tested and IPI scores. At the maximum tolerated dose of 6 mCi/m2 x 2, 5 of 6 patients (83%) reported a PR or better.