On June 14, 2017 TG Therapeutics, Inc. (NASDAQ:TGTX), reported updated clinical data from its ongoing Phase I/Ib trial of TGR-1202 (umbralisib), the Company’s oral, next generation PI3K delta inhibitor, in combination with ibrutinib, a BTK inhibitor, in patients with Chronic Lymphocytic Leukemia (CLL) and Mantle Cell Lymphoma (MCL) (Press release, TG Therapeutics, JUN 14, 2017, View Source [SID1234519542]). This study is being run in collaboration with the Blood Cancer Research Partnership (BCRP) and Dana-Farber Cancer Institute (DFCI), in Boston, MA. Data from this trial were presented today by the Principal Investigator, Matthew S. Davids, MD, of Dana-Farber Cancer Institute, during an oral session at the 14th International Conference on Malignant Lymphoma (ICML), in Lugano, Switzerland.

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Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer stated, "We continue to be impressed with the safety, tolerability and activity of the combination of TGR-1202 and ibrutinib. With this all oral combination, we are seeing high response rates, including in those patients with prior PI3K inhibitor or ibrutinib exposure. Additionally, the combination was well tolerated with over 30 patients now treated and for durations upwards of 2.5 years in this independently run, investigator initiated study." Mr. Weiss continued, "We want to thank Dr. Davids and his collaborators at DFCI and the Leukemia & Lymphoma Society for leading this important investigator driven research. Dr. Davids’ research provides another important piece of information as we try to identify the best way to use these drugs, alone or in combination. These data complement the recently reported results at ASCO (Free ASCO Whitepaper) from the triple combination of TGR-1202, ibrutinib and TG-1101, our anti-CD20 monoclonal antibody, which showed that the three-drug combination was also well-tolerated and appeared to induce even higher rates of response, with 100% ORR by iwCLL criteria and deeper responses with 26% of the CLL patients achieving a CR. We look forward to continuing to explore these combinations to drive better outcomes for patients."

Highlights from today’s presentation include the following:

Oral Presentation: Updated results of a multicenter phase I/Ib study of TGR-1202 in combination with ibrutinib in patients with relapsed or refractory MCL or CLL (Abstract #040)

This oral presentation includes data from patients with relapsed or refractory Chronic Lymphocytic Leukemia (CLL) or Mantle Cell Lymphoma (MCL) treated with TGR-1202 in combination with ibrutinib. 32 patients were evaluable for safety (18 CLL patients and 14 MCL patients), of which 31 patients were available for efficacy (17 CLL patients and 14 MCL patients). CLL patients had a median of 1.5 prior lines of therapy (range 1-6), with 2 patients receiving prior ibrutinib and 4 receiving prior PI3K inhibitors. MCL patients had a median of 3 prior lines of therapy (range 2-5), with 2 patients also receiving prior ibrutinib.

Highlights from this oral presentation include:

94% (16 of 17) of CLL patients achieved a Complete Response (CR), Partial Response (PR), or a Partial Response with lymphocytosis (PR-L), with 1 patient achieving a CR and 3 additional patients with radiographic CR
All 3 patients with prior PI3K inhibitor therapy that were evaluable for efficacy, and 1 of the 2 patients with prior ibrutinib exposure responded
1-year progression free survival (PFS) for CLL is 88% and overall survival (OS) at 1-year is 94%, (n=17), with the longest patient on study 29.5+ months
79% (11/14) ORR in patients with MCL, including 1 CR and 1 additional radiographic CR, with marked clinical benefit observed in two additional patients
Median PFS and OS for MCL is 8.4 and 11.6 months, respectively (n=11)
The combination appears well tolerated across all patients with no grade 3/4 transaminitis (liver toxicity), diarrhea, colitis or pneumonitis observed
PRESENTATION DETAILS:

The above referenced presentation is now available on the Publications page, located within the Pipeline section, of the Company’s website at www.tgtherapeutics.com/publications.cfm.