Investigational Leukemia Drug Shows Promise in Late-Stage Trial

TG Therapeutics’ investigational combination leukemia drug TG-1101 (ubilituximab), used with approved treatment Imbruvica (ibrutinib), showed positive results in a late-stage clinical trial, proving to be more effective in patients with previously treated high-risk chronic lymphocytic leukemia (CLL) than ibrutinib alone.

The trial evaluated whether adding ubilituxumab to ibrutinib would significantly improve the overall response rate by at least 20% in between the 2 groups of adult patients. The study met its primary endpoint with ubilituximab plus ibrutinib showing an 80% response rate compared with 47% in ibrutinib alone.

Patients in both groups received 420 mg of ibrutinib orally once daily. Patients in the treatment group also received intravenous infusions of TG-1101 at 900 mg dosed on days 1, 8, and 15 of cycle 1 and day 1 of cycles 2-6.

“We believe that using combination therapy to accelerate and deepen response in poor prognosis high risk CLL is critically important for patient outcomes,” Michael S. Weiss, Executive Chairman and Chief Executive Officer of TG Therapeutics, said in a press release. “And we look forward to sharing these data with the FDA in the coming months to discuss filing for accelerated approval.”

Reference

TG Therapeutics Announces Positive Topline Data from Phase 3 GENUINE Study of TG-1101 in Combination with Ibrutinib in Patients with High Risk Chronic Lymphocytic Leukemia (CLL) [news release]. TG’s website. http://ir.tgtherapeutics.com/releases.cfm. Accessed Mar. 6, 2017.