Ublituximab: Preliminary Phase I data

Preliminary data from 21 evaluable patients with relapsed or refractory CLL or NHL in the open-label, dose-escalation, U.S. Phase I UTX-TGR-103 trial showed that ublituximab in combination with TGR-1202 was well tolerated with infusion-related reactions reported as the most common adverse event. The only grade 3/4 adverse event reported in >10% of patients was neutropenia. In 5 evaluable patients with CLL/small lymphocytic leukemia (SLL), ublituximab plus TGR-1202 led to 4 partial responses and 1 case of stable disease. In 10 evaluable patients with NHL or Richter’s Syndrome, ublituximab plus TGR-1202 led to a disease control rate (DCR) of 90% and 2 of 5 patients with diffuse large B cell lymphoma (DLBCL) achieved a partial response. Data were presented at the Pan Pacific Lymphoma meeting in Koloa.

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. ...