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TG Therapeutics Announces Positive Data Safety Monitoring Board Reviews of UNITY-CLL and UNITY-NHL Clinical Trials
Mar. 08, 2019 08:55AM PST
Biotech Investing
TG Therapeutics (NASDAQ:TGTX) has announced positive data from meetings held by the independent Data Safety Monitoring Boards (DSMBs) for both the UNITY-CLL trial and the UNITY-NHL trial. As quoted in the press release: Michael S. Weiss, Executive Chairman and Chief Executive Officer of TG Therapeutics stated, “We are highly encouraged that based on the progression-free …
TG Therapeutics (NASDAQ:TGTX) has announced positive data from meetings held by the independent Data Safety Monitoring Boards (DSMBs) for both the UNITY-CLL trial and the UNITY-NHL trial.
As quoted in the press release:
Michael S. Weiss, Executive Chairman and Chief Executive Officer of TG Therapeutics stated, “We are highly encouraged that based on the progression-free survival data accumulated to date, the UNITY-CLL DSMB determined that the study was not futile and supported continuation of the trial as planned. We are also extremely pleased that the DSMBs, which collectively evaluated safety data from over 750 patients treated with umbralisib, did not raise any safety concerns and recommended that both the UNITY-CLL and the UNITY-NHL trials continue unmodified.” Mr. Weiss continued, “We look forward to presenting interim safety and efficacy data from the MZL cohort of the UNITY-NHL trial in an oral presentation next month at the AACR conference.”
The UNITY-CLL Trial DSMB
The UNITY-CLL DSMB met to conduct a pre-planned futility analysis of progression-free survival (PFS). The DSMB determined that the trial was not futile and recommended the UNITY-CLL trial continue as planned. The term ‘futility’ is used to refer to the inability of a clinical trial to achieve its primary objective. Thus, futility analyses are used to stop a clinical trial when the interim results suggest that it is unlikely to achieve statistical significance. The pre-specified futility analysis of the UNITY-CLL trial did not allow for early stopping due to positive efficacy but only for lack of efficacy.
The UNITY-CLL DSMB also reviewed safety information from all 600+ chronic lymphocytic leukemia (CLL) patients on trial, including over 300 treatment naïve and previously treated patients on umbralisib alone or in combination with ublituximab. Based on its review, no safety concerns were identified and the DSMB recommended the UNITY-CLL trial continue without modification.
The UNITY-NHL Trial DSMB
Separately, the UNITY-NHL DSMB met to review safety data on over 470 patients with non-Hodgkin’s lymphoma (NHL) across all cohorts of the trial, including all patients enrolled in the marginal zone lymphoma (MZL) cohort. Based on its review, no safety concerns were identified, and the DSMB recommended the UNITY-NHL trial continue without modification.