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TG Therapeutics, Inc. Announces Successful Outcome from Pre-Planned Interim Analysis by Independent DSMB in the UNITY-CLL Phase 3 Trial
May 23, 2017
Contribution of single agents in the combination regimen successfully established pursuant to the UNITY-CLL Special Protocol Assessment; DSMB recommends no further enrollment to single agent arms
DSMB reviewed updated safety data from more than 270 patients, finding no safety concerns and recommended continuation of enrollment without modification
Target timeline to complete enrollment updated to by Year-End 2017
"We are extremely pleased that the DSMB has once again found no safety concerns that would require modifying the study. This is particularly comforting when we consider that the safety population now includes over 60 front-line CLL patients treated for more than 6 weeks with TGR-1202 alone or in combination with TG-1101. As most who have followed this area will recall, treatment naïve CLL patients appear to be exquisitely sensitive to the autoimmune mediated side effects of idelalisib, with approximately 50% experiencing Grade 3/4 liver toxicity by week 6 in a published study," stated
ABOUT UNITY-CLL PHASE 3 TRIAL
UNITY-CLL is a Global Phase 3 randomized controlled clinical trial in patients with Chronic Lymphocytic Leukemia (CLL) that includes two key objectives: first, to demonstrate contribution of each agent in the TG-1101 + TGR-1202 regimen, and second, to demonstrate superiority in Progression Free Survival (PFS) over the standard of care to support the submission for full approval of the combination. In addition, upon completion of enrollment, this trial will evaluate Overall Response Rate (ORR) for accelerated approval. The study initially randomized patients into four treatment arms: TG-1101 plus TGR-1202, TG-1101 single agent, TGR-1202 agent, and an active control arm of obinutuzumab plus chlorambucil. Pursuant to the Special Protocol Assessment (SPA) with the
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Cautionary Statement
Some of the statements included in this press release may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. In addition to the risk factors identified from time to time in our reports filed with the Securities and Exchange Commission, factors that could cause our actual results to differ materially are the following: our ability to successfully and cost effectively enroll and complete the UNITY-CLL trial on-time or at all or deliver pivotal data on schedule; the risk that early clinical trial results, that may have influenced our decision to proceed with additional clinical trials, will not be reproduced in future studies; the risk that safety and/or efficacy data from the interim analyses from the UNITY-CLL trial will not be consistent with the final results and/or that the data will not support regulatory approval; the risk that the combination of TG-1101 and TGR-1202, referred to as TG-1303, and being studied in the UNITY clinical trials, will not prove to be a safe and efficacious combination treatment option for any indication. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at www.tgtherapeutics.com. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.
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CONTACT:Jenna Bosco Vice President- Investor RelationsTG Therapeutics, Inc. Telephone: 212.554.4351 Email: ir@tgtxinc.com
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