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

Bryone Kuss; Matthew S. Davids; Peter Hillmen; Carol Moreno; James Essell; Nicole Lamanna; Zsolt Nagy; Ulrich Jaeger; Constantine Tam; Stephan Stilgenbauer; Paolo Ghia; Julio Delgado; Diep Le; Brenda Jeglinksi; Marco Montillo

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

Bryone Kuss, Matthew S. Davids, Peter Hillmen, Carol Moreno, James Essell, Nicole Lamanna, Zsolt Nagy, Ulrich Jaeger, Constantine Tam, Stephan Stilgenbauer, Paolo Ghia, Julio Delgado, Diep Le, Brenda Jeglinksi, Marco Montillo

Research output: Contribution to journal › Meeting Abstract › peer-review

Abstract

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.

Original language	English
Article number	7533
Number of pages	1
Journal	Journal of Clinical Oncology
Volume	36
Issue number	S15
Publication status	Published - 20 May 2018
Externally published	Yes
Event	2018 American Society for Clinical Oncology Annual Meeting - Chicago, United States Duration: 1 Jun 2018 → 5 Jun 2018

Keywords

Duvelisib Monotherapy
Ofatumumab Monothapy
Relapsed/Refractory CLL

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Kuss, B., Davids, M. S., Hillmen, P., Moreno, C., Essell, J., Lamanna, N., Nagy, Z., Jaeger, U., Tam, C., Stilgenbauer, S., Ghia, P., Delgado, J., Le, D., Jeglinksi, B., & Montillo, M. (2018). 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. Journal of Clinical Oncology, 36(S15), Article 7533. http://www.verastem.com/wp-content/uploads/2018/06/DUO_-ASCO-Poster-2018.pdf

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title = "The Efficacy of Duvelisib Monotherapy Following Disease Progression on Ofatumumab Monotherapy in Patients with Relapsed/Refractory CLL or SLL in the DUO{\texttrademark} Crossover Extension Study",

abstract = "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. ",

keywords = "Duvelisib Monotherapy, Ofatumumab Monothapy, Relapsed/Refractory CLL",

author = "Bryone Kuss and Davids, {Matthew S.} and Peter Hillmen and Carol Moreno and James Essell and Nicole Lamanna and Zsolt Nagy and Ulrich Jaeger and Constantine Tam and Stephan Stilgenbauer and Paolo Ghia and Julio Delgado and Diep Le and Brenda Jeglinksi and Marco Montillo",

year = "2018",

month = may,

day = "20",

language = "English",

volume = "36",

journal = "Journal of Clinical Oncology",

issn = "0732-183X",

publisher = "American Society of Clinical Oncology",

number = "S15",

note = "2018 American Society for Clinical Oncology Annual Meeting ; Conference date: 01-06-2018 Through 05-06-2018",

}

Kuss, B, Davids, MS, Hillmen, P, Moreno, C, Essell, J, Lamanna, N, Nagy, Z, Jaeger, U, Tam, C, Stilgenbauer, S, Ghia, P, Delgado, J, Le, D, Jeglinksi, B & Montillo, M 2018, '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', Journal of Clinical Oncology, vol. 36, no. S15, 7533. <http://www.verastem.com/wp-content/uploads/2018/06/DUO_-ASCO-Poster-2018.pdf>

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. / Kuss, Bryone; Davids, Matthew S.; Hillmen, Peter et al.
In: Journal of Clinical Oncology, Vol. 36, No. S15, 7533, 20.05.2018.

Research output: Contribution to journal › Meeting Abstract › peer-review

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

SN - 0732-183X

VL - 36

JO - Journal of Clinical Oncology

JF - Journal of Clinical Oncology

IS - S15

M1 - 7533

T2 - 2018 American Society for Clinical Oncology Annual Meeting

Y2 - 1 June 2018 through 5 June 2018

ER -

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

Abstract

Keywords

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