For the 61 patients who received the 2 consolidation 90Y-epratuzumab treatments, ORR was 91.8% (56/61), with 50 patients (81.9%) achieving a CR/CRu. Eight of 16 patients (50.0%) who had less than a CR/CRu with R-CHOP converted to CR/CRu after receiving radiolabeled epratuzumab. Among these 61 patients, 12 experienced progression and/or related death, yielding an estimated 2-year EFS of 78.7% (65.1 - 87.4%) and an estimated 2-year OS of 90.1% (77.7 - 95.8%).
Separately, the Company is investigating a combination of 90Y-epratuzumab and its second-generation, humanized anti-CD20 antibody, veltuzumab, in patients with relapsed aggressive NHL. Michael B Tomblyn, MD, of H. Lee Moffitt Cancer Center, Tampa, FL, presented updated results at the same ASH medical conference, with clinical research sites from Division of Hematology, Department of Internal Medicine, Mayo Clinic, Rochester, MN; Helen F Graham Cancer Center, Newark, DE; Weill Cornell Medical College, New York, NY; and Indiana University Health Center for Cancer Care, Goshen, IN, participating in this Phase I, open-label study.
Results from 18 patients with various types of aggressive NHL who had failed 1 or more prior standard therapies were reported at the conference. The 90Y dose was repeatedly de-escalated from 15 (N=3) to 12 (N=3), 9 (N=6), and currently 6 (N=6) mCi/m 2 due to hematologic dose-limiting toxicities. Otherwise, treatment was well-tolerated with no infusion reactions.
The overall objective response rate among 17 patients who have had treatment response assessments was 53%, including one DLBCL patient (6%) with a CR continuing 12 months later. The combination is active in all NHL subgroups and across 90Y dose levels. At the maximum tolerated dose of 6 mCi/m 2 x 2, 5 of 6 patients (83%) achieved PRs."We are pleased with these encouraging early efficacy results," remarked Cynthia L. Sullivan, President and Chief Executive Officer of Immunomedics. "We will continue to develop this combination of 90Y-epratuzumab and anti-CD20 antibody therapy to hopefully become a new treatment regimen for NHL," Ms. Sullivan added. This study was supported in part by Award Number R44CA139668 from the National Cancer Institute. The content is solely the responsibility of the Company and does not necessarily represent the official views of the National Cancer Institute or the National Institutes of Health.