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TG Therapeutics TG Therapeutics Announces Combination Data Presentations at the XIX International Workshop on Chronic Lymphocytic Leukemia ( iwCLL ) September 20 , 2021 Investor & Analyst Virtual Event to Discuss Phase 1 U2 + Venetoclax Data to be held today , September 20 , 2021 at 8:30 AM ET NEW YORK , Sept. 20 , 2021 ( GLOBE NEWSWIRE ) -- TG Therapeutics , Inc. ( NASDAQ : TGTX ) , today announced data presentations at the XIX International Workshop on Chronic Lymphocytic Leukemia ( iwCLL ) . Data highlights from each presentation are included below . The Company will also host a virtual investor and analyst event today , September 20 , 2021 at 8:30 AM ET , to review the updated Phase 1 data evaluating the investigational combination of UKONIQⓇ ( umbralisib ) and ublituximab ( U2 ) plus venetoclax presented at iwCLL , as well as provide an overview of the ULTRA - V Phase 2/3 trial . Michael S. Weiss , the Company's Chairman and Chief Executive Officer , stated , " The iwCLL conference this past weekend was an exciting meeting , where we were able to share data from four combination trials , including updated data from our Phase 1/2 study of U2 plus venetoclax . Our goal has been to develop combination therapies utilizing U2 as a backbone and we believe the data presented this weekend showcase the breadth of the program , which includes combinations with targeted therapy as well as immunotherapy . With a March 25 , 2022 PDUFA date in the US , we are excited about the potential approval of the U2 regimen for CLL patients and hope you all can join us this morning for our virtual event to review some of the encouraging data presented this past weekend . " IwCLL 2021 DATA HIGHLIGHTS Oral Presentation Title : Umbralisib Plus Ublituximab ( U2 ) Is Superior to Obinutuzumab Plus Chlorambucil ( O + Chl ) in Patients with Treatment - Naïve ( TN ) and Relapsed / Refractory ( R / R ) Chronic Lymphocytic Leukemia ( CLL ) : Results from the Phase 3 UNITY - CLL Study • 421 patients were randomized to the U2 ( n = 210 ) or O + Chl ( n = 211 ) arms ; 57 % of patients were treatment - naïve and 43 % had relapsed / refractory ( R / R ) CLL • At a median follow - up of 36.7 months , U2 significantly prolonged independent review committee ( IRC ) assessed progression - free survival ( PFS ) vs O + Chl ( median 31.9 months vs 17.9 months ; hazard ratio 0.546 ( p < 0.0001 ) ) • PFS improvement with U2 vs O + Chl was consistent across all subgroups examined including treatment naïve patients ( median 38.5 months vs 26.1 months , hazard ratio 0.482 ) and relapsed / refractory patients ( median 19.5 months vs 12.9 months , hazard ratio 0.601 ) • Overall response rate ( ORR ) was significantly higher with U2 compared to O + Chl ( 83.3 % vs 68.7 % ; p < 0.001 ) • For the U2 arm , at a median treatment exposure of 21 months , most adverse events ( AEs ) were Grade 1 or 2 in severity and were relatively balanced between the treatment naïve and previously treated populations • Grade 3/4 Adverse Events ( AEs ) of clinical interest ( U2 vs O + Chl ) included elevated ALT ( 8.3 % vs 1.0 % ) , elevated AST ( 5.3 % vs 2.0 % ) , non - infectious colitis ( 1.9 % vs 0 % ) , infectious colitis ( 0.5 % vs 0.5 % ) , pneumonitis ( 0.5 % vs 0 % ) , rash ( 2.4 % vs 0.5 % ) , and opportunistic infections ( 5.8 % vs. 1.5 % ) Oral Presentation Title : A Phase 1/2 Study of Umbralisib . Ublituximab , and Venetoclax in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia ( CLL ) • Regimen was administered with 3 cycles of U2 as induction in cycles 1 through 3 , U2 plus venetoclax in cycles 4 , 5 and 6 , followed by umbralisib plus venetoclax in cycles 7 through 12 in patients with relapsed or refractory ( R / R ) CLL . Patients with centrally confirmed undetectable minimal residual disease ( uMRD ) in the bone marrow after cycle 12 were permitted to stop all therapy , while MRD detectable patients continued on single agent umbralisib . • 47 patients have now been treated as of the data cutoff with 57 % of patients previously exposed to a BTK inhibitor • Best Overall Response Rate ( ORR ) was 100 % amongst evaluable patients ( n = 46 ) , including 37 % complete response ( CR ) rate • At cycle 12 , 91 % of patients ( n = 34 ) achieved undetectable minimal residual disease ( uMRD ) in the peripheral blood ( PB ) , and 72 % of patients ( n = 32 ) achieved uMRD in the bone marrow ( BM ) • At a median follow up of 24.5 months , median progression - free survival has not been reached • Grade 3/4 adverse events ( AEs ) occurring in > 5 % of patients were neutropenia ( 28 % ) , leukopenia ( 15 % ) , lymphocytopenia ( 15 % ) , infusion related reactions ( 9 % ) , diarrhea ( 9 % ) , and anemia ( 6 % ) . No TLS events were observed during venetoclax administration Oral Poster Presentation Title : TG - 1701 , a Selective Bruton Tyrosine Kinase ( BTK ) Inhibitor , as Monotherapy and in Combination with Ublituximab and Umbralisib ( U2 ) in Patients with Chronic Lymphocytic Leukemia