On October 24, 2019 TG Therapeutics, Inc. (NASDAQ: TGTX) reported that final long-term results from the Phase 3 GENUINE study demonstrated that ublituximab in combination with ibrutinib improved progression-free survival (PFS), as determined by Independent Review Committee (IRC) (Press release, TG Therapeutics, OCT 24, 2019, View Source [SID1234542482]). The GENUINE Phase 3 study evaluated ublituximab, the Company’s novel, glycoengineered anti-CD20 monoclonal antibody, in combination with ibrutinib, compared to ibrutinib monotherapy in patients with relapsed/refractory high-risk chronic lymphocytic leukemia (CLL). As previously reported, the GENUINE study met its primary endpoint of improved IRC-assessed overall response rate (ORR), as well as increased centrally-assessed rate of minimal residual disease (MRD). The combination of ublituximab and ibrutinib was well tolerated with no new safety signals identified at a median follow-up of >4 years.
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The Company plans to present these final data at a future medical conference, as well as share the results with the U.S. Food and Drug Administration (FDA).
Michael S. Weiss, Executive Chairman and Chief Executive Officer of TG Therapeutics stated, "We are pleased with the final results from the Phase 3 GENUINE trial with median follow-up of over 4 years. The improvement in PFS observed in these high-risk CLL patients is extremely encouraging, and we look forward to presenting the full data at a future medical conference."
ABOUT THE PHASE 3 GENUINE STUDY
The Phase 3 GENUINE study is a randomized, open label, multicenter clinical trial to evaluate the safety and efficacy of ublituximab in combination with ibrutinib compared to ibrutinib monotherapy in adult patients with high-risk chronic lymphocytic leukemia (CLL) who received at least one prior therapy for their disease. In this study, high-risk was defined as having any one or more of the following: 17p deletion, 11q deletion or p53 mutation.
The study was conducted at 160 clinical trial sites in the US and Israel and randomized 126 patients. Patients received ibrutinib orally at 420 mg once daily in both arms and in the treatment arm those patients also received intravenous infusions of ublituximab at 900 mg dosed on days 1, 8 and 15 of cycle 1 and day 1 of cycles 2-6. Patients in the treatment arm who had not progressed received quarterly infusions of ubltuximab maintenance at 900 mg.