TY - JOUR
T1 - The Efficacy of Duvelisib Monotherapy Following Disease Progression on Ofatumumab Monotherapy in Patients with Relapsed/Refractory CLL or SLL in the DUO™ Crossover Extension Study
AU - Kuss, Bryone
AU - Davids, Matthew S.
AU - Hillmen, Peter
AU - Moreno, Carol
AU - Essell, James
AU - Lamanna, Nicole
AU - Nagy, Zsolt
AU - Jaeger, Ulrich
AU - Tam, Constantine
AU - Stilgenbauer, Stephan
AU - Ghia, Paolo
AU - Delgado, Julio
AU - Le, Diep
AU - Jeglinksi, Brenda
AU - Montillo, Marco
PY - 2018/5/20
Y1 - 2018/5/20
N2 - Background: Duvelisib, an oral 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) duvelisib monotherapy demonstrated significant improvement compared to ofatumumab monotherapy (PFS 13.3 vs 9.9 mo. p < 0.0001; ORR 74% vs 45% p < 0.0001) with a manageable safety profile (Flinn, ASH 2017). Study IPI-145-12 (NCT02049515) is an open-label, optional, crossover extension study where pts with confirmed progressive disease (PD) on DUO were given the option to receive the opposite treatment. Herein we present data for the 89 pts who voluntarily rolled over following PD on ofatumumab on DUO and received duvelisib on Study IPI-145-12.
AB - Background: Duvelisib, an oral 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) duvelisib monotherapy demonstrated significant improvement compared to ofatumumab monotherapy (PFS 13.3 vs 9.9 mo. p < 0.0001; ORR 74% vs 45% p < 0.0001) with a manageable safety profile (Flinn, ASH 2017). Study IPI-145-12 (NCT02049515) is an open-label, optional, crossover extension study where pts with confirmed progressive disease (PD) on DUO were given the option to receive the opposite treatment. Herein we present data for the 89 pts who voluntarily rolled over following PD on ofatumumab on DUO and received duvelisib on Study IPI-145-12.
KW - Duvelisib Monotherapy
KW - Ofatumumab Monothapy
KW - Relapsed/Refractory CLL
M3 - Meeting Abstract
VL - 36
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
SN - 0732-183X
IS - S15
M1 - 7533
T2 - 2018 American Society for Clinical Oncology Annual Meeting
Y2 - 1 June 2018 through 5 June 2018
ER -