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%).
- 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. https://bit.ly/2NdWtwR. Accessed October 24, 2019.
- 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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