TG Therapeutics says DSMB recommends continuation of UNITY-CLL Phase 3 trial
TG Therapeutics announced that the independent Data Safety Monitoring Board, or DSMB, providing oversight for the UNITY-CLL Phase 3 trial reviewed the cumulative safety data from the ongoing clinical study and informed the company that it has identified no safety concerns, and recommended the continuation of the study with no modifications. Per the protocol's pre-specified DSMB charter, the DSMB is scheduled to meet approximately every 6-9 months to review cumulative safety data. "We are encouraged by the positive outcome of the first DSMB safety review, especially since over two-thirds of the patients currently enrolled in the study are treatment naive CLL patients. Many may recall, as reported by Dr. Jennifer Brown at last year's ASH meeting, and published earlier this year in Blood, that idelalisib in treatment naive CLL patients was observed to cause rapid (most within less than5 weeks) and profound (Grade 3/4) liver toxicity in approximately 50% of the patients treated. Given those findings, we are pleased to report that the DSMB did not find any safety concerns and recommended the study continue without modification. We are also excited to report that the UNITY-CLL study continues to enroll well and we are still targeting completion of enrollment in the first half of 2018," stated Executive Chairman and Interim CEO Michael Weiss.