The phase 3 DUO trial: duvelisib vs ofatumumab in relapsed and refractory CLL/SLL by Ian W. Flinn, Peter Hillmen, Marco Montillo, Zsolt Nagy, Árpád Illés,

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The phase 3 DUO trial: duvelisib vs ofatumumab in relapsed and refractory CLL/SLL by Ian W. Flinn, Peter Hillmen, Marco Montillo, Zsolt Nagy, Árpád Illés, Gabriel Etienne, Julio Delgado, Bryone J. Kuss, Constantine S. Tam, Zoltán Gasztonyi, Fritz Offner, Scott Lunin, Francesco Bosch, Matthew S. Davids, Nicole Lamanna, Ulrich Jaeger, Paolo Ghia, Florence Cymbalista, Craig A. Portell, Alan P. Skarbnik, Amanda F. Cashen, David T. Weaver, Virginia M. Kelly, Barry Turnbull, and Stephan Stilgenbauer Blood Volume 132(23):2446-2455 December 6, 2018 ©2018 by American Society of Hematology

Ian W. Flinn et al. Blood 2018;132:2446-2455 ©2018 by American Society of Hematology

PFS in the study population. PFS in the study population. Kaplan-Meier curves of PFS assessments in CLL/SLL patients treated with monotherapy duvelisib or ofatumumab. PFS was significantly longer for duvelisib-treated patients compared with ofatumumab-treated patients by assessments of blinded IRC (13.3 months vs 9.9 months, HR = 0.52, P < .0001) (A) and investigators (17.6 months vs 9.7 months, HR = 0.40, P < .0001) (B). BID, twice daily; DUV, duvelisib; OFA, ofatumumab. Ian W. Flinn et al. Blood 2018;132:2446-2455 ©2018 by American Society of Hematology

PFS in selected study subgroups. PFS in selected study subgroups. (A) Forest plot and hazard ratios for PFS per IRC assessment on duvelisib or ofatumumab monotherapy for predefined subgroups within the total study population. Kaplan-Meier curves of PFS per IRC assessment (B) and investigator assessment (C) in the subgroup of patients with del(17p)/TP53 mutation. In this high-risk subgroup, median PFS was 12.7 months and 9.0 months (HR = 0.40, P = .0002) by IRC assessment and 13.8 months and 9.5 months (HR = 0.41, P = .0003) by investigator assessment for duvelisib and ofatumumab, respectively. “Refractory/early relapse” indicates refractory/early relapse to purine analog-based therapy; “prior anticancer therapy” indicates most recent prior anticancer therapy from randomization. LCL, lower confidence limit; UCL, upper confidence limit. Ian W. Flinn et al. Blood 2018;132:2446-2455 ©2018 by American Society of Hematology

ORR per IRC assessment and lymph node response rate for the total CLL/SLL study population for duvelisib vs ofatumumab monotherapy. ORR per IRC assessment and lymph node response rate for the total CLL/SLL study population for duvelisib vs ofatumumab monotherapy. Lymph node response was defined as ≥50% decrease in the sum of the products of target lymph nodes. Both the ORR (P < .0001) and the lymph node response rate (P < .0001) were significantly higher in duvelisib-treated patients. Ian W. Flinn et al. Blood 2018;132:2446-2455 ©2018 by American Society of Hematology

Cytokine and chemokine changes in CLL/SLL patients treated with duvelisib or ofatumumab. Cytokine and chemokine changes in CLL/SLL patients treated with duvelisib or ofatumumab. The median percent change from baseline to cycle 2 day 1 is depicted. The 10 cytokines and chemokines that showed >50% median reductions in duvelisib patients from baseline are denoted with an asterisk. Ian W. Flinn et al. Blood 2018;132:2446-2455 ©2018 by American Society of Hematology