Epratuzumab: Additional Phase IIb data

Additional data from the double-blind, dose-ranging Phase IIb EMBLEM (SL0007) trial in 227 patients showed that the 600 mg epratuzumab arm significantly improved response rate vs. placebo at week 12 (45.9% vs. 21.1%, p=0.0265). The 1,200 mg arm non-significantly improved response vs. placebo (40.5%, p=0.07). A combined analysis of patients in the 600 and 1,200 mg arms who received a cumulative 2,400 mg dose of epratuzumab showed that the compound led to a significantly higher response rate vs. placebo (43.2%, p=0.0239).

The 100, 400 and 1,800 mg epratuzumab arms led to response rates of 30.8%, 26.3% and 23.7%, respectively (p-values not disclosed). Epratuzumab was well tolerated. Patients received 600 mg IV epratuzumab or placebo at weeks 0, 1, 2 and 3; or 100, 400, 1,200 or 1,800 mg IV epratuzumab at weeks 0 and 2 and placebo at weeks 1 and 3. Immunomedics said the trial was not powered to detect significance between treatment arms, but rather to determine the optimal dose of epratuzumab for Phase III studies, which the company previously said would likely be 600 mg. Data were presented at the European League Against Rheumatism meeting in Rome. ...