On August 30, 2021 TG Therapeutics, Inc. (NASDAQ: TGTX), reported the schedule of four data presentations at the upcoming XIX International Workshop on Chronic Lymphocytic Leukemia (iwCLL), being held virtually September 17 – 20, 2021 (Press release, TG Therapeutics, AUG 30, 2021, View Source [SID1234587007]). Details of the data presentations are included below.
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"We are excited to share data from four combination clinical trials at the upcoming iwCLL conference, all of which evaluated either U2, the combination of UKONIQ plus ublituximab, alone or as a backbone in a triple combination regimen. We believe these data further highlight the potential of the U2 combination, which currently has a PDUFA date of March 25, 2022, to treat patients with CLL." Mr Weiss continued, "We are particularly excited to be able to share, earlier than expected, the updated Phase 1 results from the triple combination of U2 plus venetoclax in patients with relapsed/refractory CLL. The data shown thus far from this phase 1/2 study has been highly encouraging and led to the commencement of our ULTRA-V Phase 2/3 trial, which is also evaluating the U2 plus venetoclax triple combination."
IwCLL 2021 PRESENTATION INFORMATION
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
Abstract Number: 1083667
Presentation Date/Time: Saturday September 18, 2021 at 1:30 PM EDT/ 19:30 CEST
Session: Session 6: Front-Line Therapy of CLL
Lead Author: Wojciech Jurczak, MD, PhD, Maria Sklodowska-Curie National Research Institute of Oncology, Krakow, Poland
Oral Presentation Title: A Phase 1/2 Study of Umbralisib, Ublituximab, and Venetoclax in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)
Abstract Number: 1083987
Presentation Date/Time: Sunday September 19, 2021 at 10:50 AM EDT/ 16:50 CEST
Session: Session 8: New Agents in CLL Clinical Trials
Lead Author: Paul M. Barr, MD, Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, NY
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
Abstract Number: 1083634
Presentation Date/Time: Sunday September 19, 2021 at 2:00 PM EDT/ 20:00 CEST
Session: Poster Session
Lead Author: Chan Y. Cheah MBBS, DMSc, Linear Clinical Research, and Department of Haematology, Sir Charles Gairdner Hospital, Nedlands Western Australia, and Medical School, University of Western Australia, Crawley, Western Australia
Poster Presentation Title: Phase I/II Study of Umbralisib (TGR-1202), Ublituximab (TG-1101), and Pembrolizumab in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia and Richter’s Transformation: 5-Year Follow-up
Abstract Number: 1083523
Presentation Date/Time: Available on demand
Session: Virtual Poster Gallery
Lead Author: Lindsey E. Roeker, MD, CLL Program, Leukemia Service, Division of Hematologic Oncology, Memorial Sloan-Kettering Cancer Center, New York, NY
Currently, the conference agenda, including abstract titles, is available via the iwCLL website at View Source Full text abstracts will be publicly available on September 13, 2021.
At the time of each presentation, the data presented will be available on the Publications page, located within the Pipeline section, of the Company’s website at www.tgtherapeutics.com/publications.cfm.