ARTICLE | Clinical News

EPZ-5676: Additional Phase I data

November 10, 2014 8:00 AM UTC

Data from 28 evaluable adults with heavily pre-treated advanced hematological malignancies in an open-label, U.S. Phase I trial showed that the once-daily 54 mg/m 2 dose of IV EPZ-5676 for the first 21 days of a 28-day cycle led to 2 complete responses. Epizyme reported the same 2 objective responses in January. There were no complete responses in patients who received EPZ-5676 at doses of 12, 24, 36 and 80 mg/m 2 for the first 21 days of a 28-day cycle in the dose-escalation portion of the trial, or in patients who received 90 mg/m 2 IV EPZ-5676 for all 28 days in the expansion portion of the trial. All doses of EPZ-5676 were well tolerated in all 36 patients enrolled. The MTD was not reached. There were 2 discontinuations due to possible treatment-related adverse events. Data will be presented at the American Society of Hematology meeting in San Francisco in December. Epizyme said it plans to expand enrollment in the 54 mg/m 2 dose cohort. The company previously reported data from the trial (see BioCentury, Nov. 18, 2013). ...