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Ublituximab Plus Ibrutinib Improves PFS in Relapsed/Refractory High-Risk CLL

Gina Columbus @ginacolumbusonc
Published: Thursday, Oct 24, 2019

Michael S. Weiss, executive chairman and chief executive officer of TG Therapeutics

Michael S. Weiss

The combination of ublituximab and ibrutinib (Imbruvica) improved progression-free survival (PFS), as determined by an Independent Review Committee (IRC), compared with ibrutinib alone in patients with relapsed/refractory high-risk chronic lymphocytic leukemia (CLL), according to final long-term findings of the phase III GENUINE study.1

Regarding safety, the most common all-grade adverse events (AEs) with the combination and monotherapy, respectively, were diarrhea (42% vs 40%), fatigue (27% vs 33%), insomnia (24% vs 10%), nausea (22% vs 21%), and headache (20% vs 28%). Infusion reactions occurred in 54% of patients in the combination arm, 5% of which was grade 3 or 4. Other key AEs included neutropenia (22% vs 12%), anemia (14% vs 17%), and thrombocytopenia (14% vs 10%).


  1. TG Therapeutics Announces Final Long-Term Results from the Phase 3 GENUINE Study Demonstrated that Ublituximab in Combination with Ibrutinib Improved Progression-Free Survival in Patients with High-Risk Relapsed/Refractory Chronic Lymphocytic Leukemia as Compared to Ibrutinib Monotherapy. TG Therapeutics, Inc. Published October 24, 2019. Accessed October 24, 2019.
  2. Sharman JP, Brander DM, Mato AR, et al. Ublituximab and ibrutinib for previously treated genetically high-risk chronic lymphocytic leukemia: Results of the GENUINE phase 3 study. J Clin Oncol. 2017;35 (suppl; abstr 7504). doi: 10.1200/JCO.2017.35.15_suppl.7504.

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