TG Therapeutics (NASDAQ:TGTX) reported positive topline results from its Phase 3 trial in patients with previously untreated and relapsed/refractory chronic lymphocytic leukemia (CLL).
The trial met its primary endpoint at a prespecified interim analysis, demonstrating a statistically significant improvement in progression-free survival with a combination of umbralisib – a dual inhibitor of PI3K delta and CK1 epsilon – plus ublituximab, compared with obinutuzumab plus chlorambucil chemotherapy.
TG will stop the trial early, having demonstrated the superior efficacy of its umbralisib/ublituximab combination treatment, also known as U2.
“This outcome sets the stage for the potential approval of U2 as a novel, chemotherapy-free, treatment regimen for patients with CLL, whether they have relapsed from or are refractory to a prior therapy or have never been treated before,” executive chairman and CEO Michael Weiss said in a statement.
“We are extremely pleased with the performance of U2 in this study and very happy we were able to stop the study at this interim analysis due to the superior efficacy observed,” he added.
TG plans to submit the study data to the FDA by year-end 2020.
