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 (ClinicalTrials.gov 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.
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.
The investigators plan to submit detailed findings from the GENUINE study for presentation at an upcoming medical congress.
- 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. http://ir.tgtherapeutics.com/releasedetail.cfm?ReleaseID=1015939. Accessed March 7, 2017.