Results from the Phase 3 DUO™ Trial: A Randomized Comparison of Duvelisib Vs Ofatumumab in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Ian W. Flinn; Peter Hillmen; Marco Montillo; Zsolt Nagy; Árpád Illés; Gabriel Etienne; Julio Delgado; Bryone Jean Kuss; Constantine S. Tam; Zoltán Gasztonyi; Fritz Offner; Scott D. Lunin; Francesco Bosch; Matthew S. Davids; Nicole Lamanna; Ulrich Jaeger; Paolo Ghia; Florence Cymbalista; Craig A. Portell; Alan P. Skarbnik; Amanda Cashen; Virginia Kelly; Barry Turnbull; Stephan Stilgenbauer

Results from the Phase 3 DUO™ Trial: A Randomized Comparison of Duvelisib Vs Ofatumumab in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Ian W. Flinn, Peter Hillmen, Marco Montillo, Zsolt Nagy, Árpád Illés, Gabriel Etienne, Julio Delgado, Bryone Jean Kuss, Constantine S. Tam, Zoltán Gasztonyi, Fritz Offner, Scott D. Lunin, Francesco Bosch, Matthew S. Davids, Nicole Lamanna, Ulrich Jaeger, Paolo Ghia, Florence Cymbalista, Craig A. Portell, Alan P. SkarbnikAmanda Cashen, Virginia Kelly, Barry Turnbull, Stephan Stilgenbauer

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

Abstract

Background: Despite the recent development of novel targeted therapies to treat chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL), the disease remains incurable and many patients will eventually relapse despite optimal treatment. Additional therapies targeting novel pathways are needed for patients with relapsed/refractory CLL/SLL. Duvelisib (DUV) is an oral dual inhibitor of PI3K-δ and PI3K-γ being developed for the treatment of advanced B-cell malignancies, including CLL/SLL. In a Phase 1 study, the overall response rate (ORR) for DUV monotherapy in relapsed/refractory CLL/SLL (n=55) was 56% (with 1 complete response [CR]) per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria. Based on the safety and efficacy findings in this study, DUV 25 mg twice daily (BID) was selected as the recommended Phase 2 dose (RP2D) in CLL/SLL (O'Brien, ASH 2015). Herein we report the blinded baseline characteristics and disease history from DUO™, a Phase 3 randomized study evaluating DUV monotherapy vs ofatumumab (OFA) monotherapy in patients with relapsed or refractory CLL/SLL. The DUO study completed enrollment in December 2015 and the protocol-defined final analysis (185 progression-free survival [PFS] events) is in progress; the complete trial results will be presented at the American Society of Hematology 59thAnnual Meeting in December.

Original language	English
Pages (from-to)	493
Journal	Blood
Volume	130
Issue number	S1
Publication status	Published - Dec 2017
Externally published	Yes

Keywords

chronic lymphocytic leukemia
small lymphocytic lymphoma
treatment
Duvelisib

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Flinn, I. W., Hillmen, P., Montillo, M., Nagy, Z., Illés, Á., Etienne, G., Delgado, J., Kuss, B. J., Tam, C. S., Gasztonyi, Z., Offner, F., Lunin, S. D., Bosch, F., Davids, M. S., Lamanna, N., Jaeger, U., Ghia, P., Cymbalista, F., Portell, C. A., ... Stilgenbauer, S. (2017). Results from the Phase 3 DUO™ Trial: A Randomized Comparison of Duvelisib Vs Ofatumumab in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma. Blood, 130(S1), 493. https://www.sciencedirect.com/science/article/pii/S0006497119810108

@article{390a8a2a838b451eba9ce3e10d6a511d,

title = "Results from the Phase 3 DUO{\texttrademark} Trial: A Randomized Comparison of Duvelisib Vs Ofatumumab in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma",

abstract = "Background: Despite the recent development of novel targeted therapies to treat chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL), the disease remains incurable and many patients will eventually relapse despite optimal treatment. Additional therapies targeting novel pathways are needed for patients with relapsed/refractory CLL/SLL. Duvelisib (DUV) is an oral dual inhibitor of PI3K-δ and PI3K-γ being developed for the treatment of advanced B-cell malignancies, including CLL/SLL. In a Phase 1 study, the overall response rate (ORR) for DUV monotherapy in relapsed/refractory CLL/SLL (n=55) was 56% (with 1 complete response [CR]) per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria. Based on the safety and efficacy findings in this study, DUV 25 mg twice daily (BID) was selected as the recommended Phase 2 dose (RP2D) in CLL/SLL (O'Brien, ASH 2015). Herein we report the blinded baseline characteristics and disease history from DUO{\texttrademark}, a Phase 3 randomized study evaluating DUV monotherapy vs ofatumumab (OFA) monotherapy in patients with relapsed or refractory CLL/SLL. The DUO study completed enrollment in December 2015 and the protocol-defined final analysis (185 progression-free survival [PFS] events) is in progress; the complete trial results will be presented at the American Society of Hematology 59thAnnual Meeting in December.",

keywords = "chronic lymphocytic leukemia, small lymphocytic lymphoma, treatment, Duvelisib",

author = "Flinn, {Ian W.} and Peter Hillmen and Marco Montillo and Zsolt Nagy and {\'A}rp{\'a}d Ill{\'e}s and Gabriel Etienne and Julio Delgado and Kuss, {Bryone Jean} and Tam, {Constantine S.} and Zolt{\'a}n Gasztonyi and Fritz Offner and Lunin, {Scott D.} and Francesco Bosch and Davids, {Matthew S.} and Nicole Lamanna and Ulrich Jaeger and Paolo Ghia and Florence Cymbalista and Portell, {Craig A.} and Skarbnik, {Alan P.} and Amanda Cashen and Virginia Kelly and Barry Turnbull and Stephan Stilgenbauer",

year = "2017",

month = dec,

language = "English",

volume = "130",

pages = "493",

journal = "Blood",

issn = "0006-4971",

publisher = "Elsevier B.V.",

number = "S1",

}

Flinn, IW, Hillmen, P, Montillo, M, Nagy, Z, Illés, Á, Etienne, G, Delgado, J, Kuss, BJ, Tam, CS, Gasztonyi, Z, Offner, F, Lunin, SD, Bosch, F, Davids, MS, Lamanna, N, Jaeger, U, Ghia, P, Cymbalista, F, Portell, CA, Skarbnik, AP, Cashen, A, Kelly, V, Turnbull, B & Stilgenbauer, S 2017, 'Results from the Phase 3 DUO™ Trial: A Randomized Comparison of Duvelisib Vs Ofatumumab in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma', Blood, vol. 130, no. S1, pp. 493. <https://www.sciencedirect.com/science/article/pii/S0006497119810108>

TY - JOUR

T1 - Results from the Phase 3 DUO™ Trial

T2 - A Randomized Comparison of Duvelisib Vs Ofatumumab in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

AU - Flinn, Ian W.

AU - Hillmen, Peter

AU - Montillo, Marco

AU - Nagy, Zsolt

AU - Illés, Árpád

AU - Etienne, Gabriel

AU - Delgado, Julio

AU - Kuss, Bryone Jean

AU - Tam, Constantine S.

AU - Gasztonyi, Zoltán

AU - Offner, Fritz

AU - Lunin, Scott D.

AU - Bosch, Francesco

AU - Davids, Matthew S.

AU - Lamanna, Nicole

AU - Jaeger, Ulrich

AU - Ghia, Paolo

AU - Cymbalista, Florence

AU - Portell, Craig A.

AU - Skarbnik, Alan P.

AU - Cashen, Amanda

AU - Kelly, Virginia

AU - Turnbull, Barry

AU - Stilgenbauer, Stephan

PY - 2017/12

Y1 - 2017/12

N2 - Background: Despite the recent development of novel targeted therapies to treat chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL), the disease remains incurable and many patients will eventually relapse despite optimal treatment. Additional therapies targeting novel pathways are needed for patients with relapsed/refractory CLL/SLL. Duvelisib (DUV) is an oral dual inhibitor of PI3K-δ and PI3K-γ being developed for the treatment of advanced B-cell malignancies, including CLL/SLL. In a Phase 1 study, the overall response rate (ORR) for DUV monotherapy in relapsed/refractory CLL/SLL (n=55) was 56% (with 1 complete response [CR]) per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria. Based on the safety and efficacy findings in this study, DUV 25 mg twice daily (BID) was selected as the recommended Phase 2 dose (RP2D) in CLL/SLL (O'Brien, ASH 2015). Herein we report the blinded baseline characteristics and disease history from DUO™, a Phase 3 randomized study evaluating DUV monotherapy vs ofatumumab (OFA) monotherapy in patients with relapsed or refractory CLL/SLL. The DUO study completed enrollment in December 2015 and the protocol-defined final analysis (185 progression-free survival [PFS] events) is in progress; the complete trial results will be presented at the American Society of Hematology 59thAnnual Meeting in December.

AB - Background: Despite the recent development of novel targeted therapies to treat chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL), the disease remains incurable and many patients will eventually relapse despite optimal treatment. Additional therapies targeting novel pathways are needed for patients with relapsed/refractory CLL/SLL. Duvelisib (DUV) is an oral dual inhibitor of PI3K-δ and PI3K-γ being developed for the treatment of advanced B-cell malignancies, including CLL/SLL. In a Phase 1 study, the overall response rate (ORR) for DUV monotherapy in relapsed/refractory CLL/SLL (n=55) was 56% (with 1 complete response [CR]) per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria. Based on the safety and efficacy findings in this study, DUV 25 mg twice daily (BID) was selected as the recommended Phase 2 dose (RP2D) in CLL/SLL (O'Brien, ASH 2015). Herein we report the blinded baseline characteristics and disease history from DUO™, a Phase 3 randomized study evaluating DUV monotherapy vs ofatumumab (OFA) monotherapy in patients with relapsed or refractory CLL/SLL. The DUO study completed enrollment in December 2015 and the protocol-defined final analysis (185 progression-free survival [PFS] events) is in progress; the complete trial results will be presented at the American Society of Hematology 59thAnnual Meeting in December.

KW - chronic lymphocytic leukemia

KW - small lymphocytic lymphoma

KW - treatment

KW - Duvelisib

M3 - Meeting Abstract

SN - 0006-4971

VL - 130

SP - 493

JO - Blood

JF - Blood

IS - S1

ER -

Results from the Phase 3 DUO™ Trial: A Randomized Comparison of Duvelisib Vs Ofatumumab in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Abstract

Keywords

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