Ublituximab: Phase II final data

Final data from 15 patients with previously treated mantle cell lymphoma (MCL) in the open-label, U.S. Phase II UTX-IB-104 trial showed that 900 mg IV ublituximab plus once-daily oral Imbruvica ibrutinib led to an ORR of 87%, including 5 complete responses and 8 partial responses. The combination also led to median reductions in tumor burden of 62% at week 8 and 76% at week 20. The trial enrolled patients with MCL or chronic lymphocytic lymphoma (CLL)/small lymphocytic leukemia (SLL) that is relapsed or refractory to >=1 prior therapy to receive 600 or 900 mg ublituximab on days 1, 8 and 15 of the first 28-day cycle and on day 1 of cycles 2-6 plus once-daily Imbruvica. Data were presented at the American Society of Hematology meeting in Orlando. TG previously reported data from the trial (see BioCentury, June 16, 2014). The Phase III GENUINE trial is evaluating ublituximab plus Imbruvica compared to Imbruvica alone in patients with high-risk CLL. ...