TG Therapeutics, Inc. Announces Successful Outcome from the First Pre-Planned Interim Analysis by Independent DSMB of the DLBCL Cohort in the UNITY-NHL Phase 2b Trial
Based on pre-set hurdles of Overall Response Rate (ORR) the DSMB recommends continued enrollment in the TGR-1202 + TG-1101 ("U2") arm and no further enrollment into the single agent TGR-1202 arm
As set forth in the protocol, single agent TGR-1202 arm will be replaced with the triple combination of TG-1101, TGR-1202 and bendamustine
ABOUT UNITY-NHL PHASE 2b TRIAL
UNITY-NHL is a global Phase 2b clinical trial evaluating TG-1101 and TGR-1202, ("U2"), in patients with various types of B-cell lymphoma. The trial consists of three independent cohorts enrolling patients with relapsed or refractory Diffuse Large B-cell Lymphoma (DLBCL), Follicular Lymphoma (FL), Small Lymphocytic Lymphoma (SLL), and Marginal Zone Lymphoma (MZL). The study is evaluating the U2 combination and the combination of U2 + bendamustine in patients with DLBCL; TGR-1202 monotherapy and in the U2 combination in patients with FL and SLL; and TGR-1202 monotherapy in patients with MZL.
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-NHL trial on-time or at all or deliver 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 DLBCL cohort of the UNITY-NHL trial will not be consistent with the final results and/or that the final data will not support regulatory approval; the risk that the combination of TG-1101 and TGR-1202, referred to as TG-1303 or "U2", 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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Jenna BoscoVice President- Investor Relations TG Therapeutics, Inc.Telephone: 212.554.4351 Email: email@example.com
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