ASCO: GENUINE phase III study

Effect of adding ublituximab to ibrutinib on PFS, ORR, and MRD negativity in previously treated high-risk chronic lymphocytic leukemia: Final results of the GENUINE phase III study

Abstract Number : 8022

Abstract Type : Poster Discussion Session

Indication : Chronic Lymphocytic Leukemia

Intervention : Ublituximab

Company : TG Therapeutics

Technology : ADCC


117 pts were treated (59 in UTX + IB arm; 58 in IB arm). Med age was 66 yrs and med # of prior Tx was 1 (range 1-5) for each arm. Baseline features were relatively balanced including ECOG, gender, and med time since diagnosis (6+ yrs). 17p del was greater in the IB arm (50% vs 44%); bulky disease was greater in UTX + IB arm (47% vs 28%); IGHV-unmut was 83% for both arms. At data-cutoff of Sep 1, 2019, AEs were comparable between the arms, except infusion reactions (UTX + IB: All G 53% / G 3/4 3%) and neutropenia (All G 36% vs 21%, G 3/4 19% vs. 12%) which were higher for UTX + IB. At a med follow up of 42 mos, all efficacy endpoints were in favor of UTX + IB (see Table).


In contrast to prior studies adding rituximab to IB, GENUINE is the first randomized trial to demonstrate a PFS benefit with the addition of an anti-CD20 to IB. Increasing depth of response (CR rate, MRD-neg) post first year of Tx supports maintenance therapy with UTX.


CD20 inh + BTK inh has already proved survival and efficacy in other trials, Encouraging results in 17p deletion/TP53 mutation population (mPFS: NR@50 mos follow up vs 18.9 mos) and patients with 11q deletion (mPFS NR@50 mos vs 47.2 mos).

Refer to Chronic Lymphocytic Leukemia Market report for detailed Insights.