On January 4, 2017 TG Therapeutics, Inc. (NASDAQ:TGTX) reported the opening of an investigator initiated Phase 2 study at the University of Nebraska Medical Center (UNMC) to evaluate the safety and efficacy of TGR-1202, the Company’s oral PI3K delta inhibitor in combination with ibrutinib, in patients with relapsed or refractory Diffuse Large B-cell Lymphoma (DLBCL) (Press release, TG Therapeutics, JAN 4, 2017, View Source [SID1234517258]). TG Therapeutics and Janssen Pharmaceuticals will each provide drug and equally share study-related costs.

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The rationale for combining these two agents is based on the prior clinical activity and tolerable safety profile observed with TGR-1202 both alone and in combination with ibrutinib in previous studies, as well as preclinical work conducted as part of a research collaboration with Dr. Michael Green and the University of Nebraska Medical Center’s Lymphoma Precision Medicine Laboratory in Omaha, NE. The combination of TGR-1202 and ibrutinib has been studied previously in patients with Chronic Lymphocytic Leukemia (CLL) and non-Hodgkin’s lymphoma, both with and without the addition of the anti-CD20 monoclonal antibody TG-1101 (ublituximab). Data on the combination of TGR-1202 plus ibrutinib were presented most recently at the 2016 American Society of Hematology (ASH) (Free ASH Whitepaper) meeting, with data demonstrating an acceptable safety profile at full doses of both ibrutinib and TGR-1202.

The Phase 2 study will evaluate the safety and efficacy of the combination of TGR-1202 and ibrutinib, as well as explore correlative analyses related to the combination.

"We are excited to launch this study led by Drs. Matthew Lunning and Michael Green. Dr. Lunning has extensive experience treating lymphoma patients with TGR-1202 as a doublet in combination with TG-1101 and also as a triple therapy with ibrutinib. While the triple combination appears safe, well tolerated and active, looking at the effects of the all oral doublet combination will expand our understanding of the effects of these agents together and the contribution of TG-1101 in a triple combination," stated Michael S. Weiss, the Company’s Executive Chairman and Interim Chief Executive Officer.

"Success with small molecule inhibitors that abrogate the abnormal signaling through the BCR pathway observed in B-cell malignancies has brought upon an exciting paradigm shift in the management of B-cell NHL. However, DLBCL patients who relapse from transplant or are refractory to front-line or subsequent therapies continue to have a poor prognosis and new novel combinations are desperately needed. At present, targeted agents against the BCR pathway have been primarily explored as single agents or in combination with a CD20 monoclonal antibody. Based on the existing clinical data in other lymphomas and the exciting preclinical data completed here by my colleague Dr. Green at UNMC, we are excited to launch this novel chemo-free all oral combination trial of TGR-1202 and ibrutinib which may be an attractive combination for this difficult to treat patient population," stated Dr. Matthew Lunning of the Fred & Pamela Buffett Cancer Center, which is the National Cancer Institute-designated cancer center located on the campus of UNMC and its clinical partner, Nebraska Medicine, in Omaha, NE.

This study is currently open to enrollment. More information on this clinical study can be found at www.clinicaltrials.gov.