TG Therapeutics (TGTX) CEO shared data and regulatory update
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TG Therapeutics (NASDAQ: TGTX) disclosed:
On January 27, 2022, TG Therapeutics, Inc. (the “Company”) participated in a webcast fireside chat during the B. Riley Securities’ 2022 Virtual Oncology Investor Conference. During the webcast, Michael S. Weiss, Chief Executive Officer of the Company, shared a data and regulatory update. Mr. Weiss noted that the Company was nearing completion of a submission to the U.S. Food and Drug Administration (FDA) of updated Overall Survival (OS) analyses from the UNITY-CLL Phase 3 study evaluating the investigational U2 combination (UKONIQ® (umbralisib) and ublituximab) compared to the control arm of obinutuzumab plus chlorambucil and that the FDA imposed a partial clinical hold on select studies of U2 and its components for chronic lymphocytic leukemia (CLL) and non-Hodgkin's lymphoma (NHL).
With regard to the data update, Mr. Weiss noted that the updated OS results from the UNITY-CLL study, showed an improvement from the preliminary data originally shared with the FDA, and previously disclosed on November 30, 2021, which was at that time an OS hazard ratio of 1.23 and when censoring for COVID-19 related deaths a hazard ratio of 1.04. An OS hazard ratio above 1.00 implies potential risk that the investigational therapy is causing harm and below 1.00 implies the possibility the drug is improving survival. The UNITY-CLL study was not powered for OS. Neither the original preliminary results nor the updated preliminary results were statistically significant, and the results are expected to change over time as more events occur. The original preliminary OS Hazard Ratio and the updated information discussed today were as of the same data cutoff date of September 2021.
With regard to the partial clinical hold, Mr. Weiss noted that no new patients may be enrolled to the select CLL/NHL studies identified by FDA, however patients on these studies who are deriving clinical benefit can continue on therapy once they have been reconsented. Mr. Weiss also noted that the partial clinical hold was not based on any new information provided by the Company to the FDA but appears to be based on the same data and concerns that gave rise to the previously announced Oncologic Drug Advisory Committee (ODAC) meeting, which is set to take place in the March/April 2022 timeframe. Most studies included in the partial clinical hold were previously closed to new enrollment or were on Company administrative hold to new enrollment. The Company does not expect to provide an update on the partial clinical hold prior to the ODAC meeting.
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Create E-mail Alert Related CategoriesCorporate News, FDA, Management Comments
Related EntitiesB. Riley, AdCom, FDA
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