On December 6, 2016 TG Therapeutics, Inc. (NASDAQ:TGTX), reported that the target enrollment of 120 patients in the GENUINE Phase 3 study has been met and enrollment will be closed shortly (Press release, TG Therapeutics, DEC 6, 2016, View Source [SID1234516974]). The GENUINE Phase 3 study is a randomized study of TG-1101, the Company’s novel, glycoengineered anti-CD20 monoclonal antibody in combination with ibrutinib, the oral Bruton’s tyrosine kinase (BTK), versus ibrutinib alone in approximately 120 patients with high-risk relapsed or refractory Chronic Lymphocytic Leukemia (CLL). In October, the study was modified to convert the primary endpoint solely to Overall Response Rate (ORR). If the study results are positive, and subject to a positive outcome of pre-BLA meeting with the FDA, the Company plans to utilize the results to file for accelerated approval. The Company expects to release top-line data from the GENUINE Phase 3 study in the first half of 2017.
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Michael S. Weiss, the Company’s Executive Chairman and Interim CEO commenting on the announcement stated, "Today’s news puts us on a clear path toward our first pivotal data for TG-1101. As demonstrated in our Phase 2 study evaluating TG-1101 plus ibrutinib, we believe the addition of an anti-CD20 monoclonal antibody can enhance the clinical response of single agent ibrutinib by more rapidly reducing tumor burden, increasing the rate of response, deepening responses and, ideally, leading to better long-term outcomes. Overall response rate has been utilized as an acceptable surrogate endpoint for improved progression free survival and overall survival for a number of recent approvals in high-risk CLL and we believe the results, if positive, may support an accelerated approvable for the combination. We want to thank our clinical collaborators and their patients for their participation in this study."