On December 5, 2016 TG Therapeutics, Inc. (NASDAQ:TGTX), reported the presentation of combination data from a Phase 1b study evaluating TGR-1202, the Company’s once-daily PI3K delta inhibitor, in combination with ibrutinib, the oral Bruton’s tyrosine kinase (BTK) (Press release, TG Therapeutics, DEC 5, 2016, View Source [SID1234516937]). This study is being run in collaboration with the Blood Cancer Research Partnership (BCRP) and Dana-Farber Cancer Institute (DFCI), 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 58th American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting in San Diego, CA.

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Michael S. Weiss, the Company’s Executive Chairman and Interim CEO commenting on the data said, "We and our investigators continue to be impressed with the ease of combining TGR-1202 with other novel agents. Here Dr. Davids demonstrated that the double blockade of the BCR pathway with dual oral once-daily inhibitors can be performed safely and conveniently, and derives high response rates in patients with both CLL and MCL. This all oral approach offers a unique and highly active alternative for patients who do not want to receive infused therapies but still want to advance their treatment beyond single agent ibrutinib, which may offer multiple benefits over single agent therapy. With one bone marrow confirmed complete response (CR) and 5 additional deep responses nearing radiographic CR out of the 17 evaluable CLL patients, we and our investigators believe we are seeing activity beyond what one might expect from either of these agents alone. We want to thank Dr. Davids and his collaborators at DFCI and the Leukemia & Lymphoma Society for providing support for this important investigator driven research and we look forward to follow-up data in the future from this study and data from our own triple therapy of TG-1101 plus TGR-1202 plus ibrutinib, which we are targeting for presentation next year."

The following summarizes the key highlights from this oral presentation which occurred today:

Oral Presentation: TGR-1202 in Combination with Ibrutinib in Patients with Relapsed or Refractory CLL or MCL: Preliminary Results of a Multicenter Phase I/Ib Study (Abstract Number 641)

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. 31 patients were evaluable for safety (18 CLL patients and 13 MCL patients), of which 28 patients were available for efficacy (17 CLL patients and 11 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:

88% (15 of 17) Overall Response Rate (ORR) (including Complete Response (CR), Partial Response (PR), and Partial Response with lymphocytosis (PR-L)) in patients with CLL, with 1 patient achieving a bone marrow confirmed CR and 5 patients with a > 80% nodal reduction, nearing radiographic CR
1 year progression free survival (PFS) and overall survival (OS) for CLL is 94% (n=17), with the longest patient on study approaching two years
73% (8/11) ORR in patients with MCL, with clinical benefit observed in two additional patients
1 year PFS and OS for MCL is 37% and 52%, 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 available on the Company’s website at www.tgtherapeutics.com, located on the Publications page.