On December 4, 2018 TG Therapeutics, Inc. (NASDAQ: TGTX), reported updated clinical data from its Phase I/II trial of ublituximab (TG-1101), the Company’s novel glycoengineered anti-CD20 monoclonal antibody in combination with umbralisib (TGR-1202), the Company’s oral, next generation PI3K delta inhibitor, and pembrolizumab, in patients with relapsed/refractory Chronic Lymphocytic Leukemia (CLL) and Richter’s Transformation (RT) (Press release, TG Therapeutics, DEC 4, 2018, View Source [SID1234531857]). Data from this trial were presented yesterday during an oral session at the 60th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition.

Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer, stated, "We were excited to share the data presented from the combination of U2 plus pembrolizumab. Due to potentially overlapping immune-mediated toxicity, this is the first trial where a PI3K delta inhibitor has been combined with a PD-1/PD-L1 inhibitor, again highlighting the unique combinability of the U2 regimen. In addition to demonstrating that these drugs could be safely combined, we were encouraged to see favorable response rates in both RT and BTK refractory CLL patients, a subset of patients that are historically challenging to treat." Mr. Weiss continued, "Our proprietary anti-PD-L1, TG-1501, has now completed Phase 1 dose escalation, and we believe the data presented today set the stage for the commencement of the combination of U2 plus TG-1501, in the coming months."

Below summarizes the oral presentation.

Phase I/II Study of Umbralisib (TGR-1202) in Combination with Ublituximab (TG-1101) and Pembrolizumab in Patients with Relapsed/Refractory CLL and Richter’s Transformation (Publication Number: 297)

This oral presentation includes data from patients with relapsed or refractory CLL or Richter’s Transformation treated with the triple combination of ublituximab, umbralisib, and pembrolizumab. Fifteen patients were evaluable for safety (10 CLL patients and 5 RT patients) and 14 were evaluable for efficacy (10 CLL and 4 RT), with one RT patient too early to evaluate. Data highlights include:

● The triple combination was well tolerated, with immune mediated toxicities not appearing above what would be expected with either umbralisib or pembrolizumab alone
● 90% (9 of 10) Overall Response Rate (ORR) in patients with relapsed/refractory CLL, including one Complete Response (CR)
● 80% (4 of 5) ORR in BTK refractory CLL patients, of which 3 of 4 BTK refractory CLL responders achieved their response to U2 alone prior to introduction of pembrolizumab
● 50% (2 of 4) ORR in RT, with both responses being a CR
● Responses have been durable, and a median progression-free survival has not yet been reached
● The first patient treated remains progression-free for 36+ months, having now been off therapy for more than 24 months

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