Ublituximab: Phase I/II data

Data from 30 evaluable patients with relapsed and refractory hematologic malignancies in an open-label, dose-escalation, U.S. Phase I/II trial showed that 450-1200 mg IV ublituximab led to an ORR of 43%. In 6 patients with chronic lymphocytic leukemia (CLL), the ORR was 67%, including 4 partial responses. In 18 patients with indolent non-Hodgkin’s lymphoma (NHL), the ORR was 44%, including 4 complete responses and 4 partial responses. In 6 patients with aggressive NHL, the ORR was 17%, including 1 partial response. Median PFS for all patients was 34 weeks. Ublituximab was well tolerated with infusion-related reactions reported as the most common adverse event. Data were presented at the American Society of Clinical Oncology meeting in Chicago.

Ublituximab has Orphan Drug designation in the U.S. to treat nodal marginal zone lymphoma and to treat extranodal marginal zone lymphoma (mucosa-associated lymphatic tissue), which are both rare subtypes of NHL, and Orphan Drug designation in the U.S. and Europe for B cell CLL. The compound is in Phase I/II testing to treat relapsed or refractory NHL and to treat B cell lymphoid malignancies in patients previously treated with anti-CD20 antibody therapy. ...