TG Therapeutics Inc. said its phase 3 study of TG-1101, or ublituximab, in combination with ibrutinib, in patients with previously treated high risk chronic lymphocytic leukemia, met its primary endpoint.

Treatment with ublituximab plus ibrutinib reached a 78% overall response rate with a 7% complete response rate, compared to 45% overall response rate with 0% complete response rate for ibrutinib alone.

Additionally, 19% minimal residual disease, or MRD, negativity was observed in the experimental arm, compared to 2% MRD negativity for ibrutinib alone.

Ublituximab is a novel, glycoengineered monoclonal antibody that targets certain white blood cells.