TG Therapeutics Reports Positive Study Data

TG Therapeutics said data were positive from the chemo-free triple combination of TGR-1202 (umbralisib), the company’s oral, next generation PI3K delta inhibitor, TG-1101, and ibrutinib. It also reiterated earlier clinical data were positive from its Phase 3 GENUINE trial of TG-1101, the company’s glycoengineered anti-CD20 monoclonal antibody in combination with ibrutinib, the BTK inhibitor.

The company said both studies demonstrated an approach to potentially improve outcomes for Chronic Lymphocytic Leukemia patients with high-risk cytogenetics. It believes the data provide a compelling case for accelerated approval given the demonstrated clinical benefit with limited additional safety risk, and it plans to share these data formally with the Food and Drug Administration later this year.

By Stephen Holmes