On November 27, 2017 TG Therapeutics (NASDAQ:TGTX) reported that along with SWOG, the global cancer clinical trials group funded by the National Cancer Institute (NCI), it has initiated a three arm Phase II trial evaluating the combination of TGR-1202 (umbralisib), the Company’s PI3K delta inhibitor, plus obinutuzumab, compared to the combination of obinutuzumab plus lenalidomide, and obinituzumab plus CHOP, in patients with early relapsing or refractory Follicular Lymphoma (FL) (Grade I, II, IIIa) (Press release, TG Therapeutics, NOV 27, 2017, View Source [SID1234522247]). Target enrollment will be 50 patients per arm.
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The primary outcome of this study is to assess the Complete Response (CR) rate following six cycles of treatment. Key secondary outcomes include ORR, DOR and PFS. The safety profile of each of these regimens will also be evaluated. The study will be independently run by SWOG, which has received NC funding since 1956. TG has agreed to provide TGR-1202 free of charge for use in the study. The goal of the study is to identify safe and effective novel combinations that can be used to manage these challenging early relapsing Follicular Lymphoma (FL) patients. The study is now open at over 100 hospitals, cancer centers, and other clinical sites across the US. More information about the study can be found at www.clinicaltrials.gov, Identifier NCT03269669.
Dr. Paul Barr, director of the Clinical Trials Office for Wilmot Cancer Institute at the University of Rochester Medical Center and leader of this Phase II trial, stated: "This is an extremely important study for patients with early, relapsed follicular lymphoma because they need new treatment options. Follicular lymphoma patients who relapse within two years of front-line immuno-chemotherapy are generally recognized to have the poorest outcomes. We chose these arms based on the best available clinical research suggesting these were the most promising targets for therapeutic intervention in the treatment of FL. The PI3K delta class have shown impressive single agent activity in the treatment of FL, however, the safety profile of the currently available first generation PI3K delta’s are not ideal. We are pleased that TG has agreed to supply TGR-1202 for this study, as this agent appears to offer a unique safety profile compared to prior PI3K-delta inhibitors while still maintaining encouraging clinical activity in patients with NHL. We are very excited that enrollment has now begun and expect a very rapid enrollment period."
Michael S. Weiss, Executive Chairman and Chief Executive Officer, stated, "We are extremely pleased that SWOG has selected TGR-1202 for inclusion in this important trial. We believe this trial will showcase treatment strategies that may significantly improve outcomes for early relapsing patients and in particular, demonstrate the utility of TGR-1202 in FL. To us, the inclusion of TGR-1202 validates our belief of best-in-class qualities of TGR-1202 and the importance of PI3K delta class in FL."