Ublituximab: Phase II data

Data from 10 evaluable CLL and MCL patients in the open-label, U.S. Phase II UTX-IB-104 trial showed that IV ublituximab plus once-daily oral Imbruvica ibrutinib led to an ORR of 90%. Specifically, in 7 CLL patients, there were 6 partial responses (PRs) and 1 case of stable disease. In 3 MCL patients, there was 1 CR and 2 PRs. Ublituximab plus Imbruvica was well tolerated in 28 patients evaluable for safety and day 1 infusion-related reactions were the most common adverse event reported. The trial is enrolling about 60 patients with MCL or CLL/small lymphocytic leukemia (SLL) that is relapsed or refractory to >=1 prior therapy to receive 600 or 900 mg ublituximab on days 1, 8 and 15 of the first 28-day cycle and on day 1 of cycles 2-6 plus once-daily Imbruvica. TG Therapeutics said the addition of ublituximab to Imbruvica appeared to control Imbruvica-related lymphocytosis in CLL patients, with a median 79% reduction in absolute lymphocyte count by cycle 4. Data were presented at the European Hematology Association meeting in Milan. Additional data are slated to be presented at the American Society of Hematology meeting in San Francisco in December.

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 non-Hodgkin's lymphoma (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. ...