Additional Relevant Details The data, which was presented at the 2015 International Conference on Malignant Lymphoma (ICML) in Lugano, Switzerland, demonstrates the combination to be well tolerated with limited grade 3/4 adverse events observed. An 88% overall response rate (ORR) was reported at month 6 for all patients treated, with a 95% ORR observed in patients with high risk CLL (presence of a 17p or 11q deletion or a TP53 mutation). These data are described further in the manuscript titled, "Ublituximab (TG-1101), a novel, glycoengineered anti-CD20 antibody, in combination with ibrutinib is safe and highly active in patients with relapsed and/or refractory chronic lymphocytic leukemia: results of a phase 2 trial,"

 The results from this study support the GENUINE Phase 3 study, and given the dramatic and rapid responses seen in this Phase 2, we are confident in the success of GENUINE.