Adding ublituximab (TG-1101) to ibrutinib significantly improved the proportion of patients with high-risk chronic lymphocytic leukemia (CLL) achieving an objective response compared with ibrutinib alone, according to a press release by TG Therapeutics.1

Preliminary results of the multicenter, open-label, phase 3 GENUINE trial ( Identifier: NCT02301156) demonstrated a significant improvement in overall response rate with ublituximab plus ibrutinib compared with ibrutinib alone in both the intent-to-treat population (P = .001) and the treated population (80% vs 47%; P < .001).

In addition to overall response rate, the investigators observed advantages with the combination in radiographic complete response rate, progression-free survival, and time to response.

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The combination was well-tolerated and the safety profile was consistent with findings from a previously reported phase 2 study. The most common adverse events among patients treated with ublituximab plus ibrutinib in the phase 2 trial were infusion-related reaction, diarrhea, fatigue, cough, rash, and nausea.

The study enrolled 126 previously treated patients from the United States and Ireland with high-risk CLL, defined as having 1 or more of the following: 17p deletion, 11q deletion, or p53 mutation. Participants were randomly assigned 1:1 to receive intravenous ublituximab, a highly potent next generation glycoengineered anti-CD20 monoclonal antibody, plus ibrutinib or ibrutinib monotherapy.

RELATED: CLL: Long-term Outcomes After Ibrutinib Discontinuation

The investigators plan to submit detailed findings from the GENUINE study for presentation at an upcoming medical congress.


  1. TG Therapeutics announces positive topline data from phase 3 GENUINE study of TG-1101 in combination with ibrutinib in patients with high risk chronic lymphocytic leukemia (CLL) [news release]. New York, NY: TG Therapeutics; March 6, 2017. Accessed March 7, 2017.