Conference Proceedings
The Efficacy and Safety of Duvelisib Following Disease Progression on Ofatumumab in Patients with Relapsed/Refractory CLL or SLL: Updated Results from the DUO Crossover Extension Study
Matthew S Davids, Bryone J Kuss, Peter Hillmen, Marco Montillo, James Essell, Nicole Lamanna, Zsolt Nagy, Constantine S Tam, Stephan Stilgenbauer, Paolo Ghia, Julio Delgado, Le NgocDiep, Stephanie Lustgarten, David T Weaver, Ulrich Jaeger
BLOOD | AMER SOC HEMATOLOGY | Published : 2018
Abstract
Abstract Background: Duvelisib (DUV), an oral, first-in-class dual inhibitor of PI3K-δ,-γ, is being developed for the treatment of hematologic malignancies, including relapsed/refractory (RR) CLL/SLL. In the Phase 3 DUO study (NCT02004522) DUV monotherapy demonstrated a significant improvement in efficacy compared to ofatumumab (OFA) monotherapy (median PFS [mPFS] 13.3 vs 9.9 mo., p<0.0001; ORR 74% vs 45%, p <0.0001) with a manageable safety profile (Flinn, Blood, in press). Study IPI-145-12 (NCT02049515) is an open-label, optional, crossover extension study where patients (pts) with radiologically confirmed progressive disease (PD) on DUO were given the option to receive the ..
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