Effect of dose modifications on response to duvelisib in patients with relapsed/refractory CLL/SLL in the duo trial

Paolo Ghia; Ian W. Flinn; Nicole Lamanna; Marco Montillo; Árpád Illés; Gabriel Etienne; Julio Delgado; Bryone Kuss; Constantine Tam; Fritz Offner; Francesco Bosch; Matthew S. Davids; Ulrich Jager; Florence Cymbalista; David T. Weaver; Stephanie Lustgarten; Hagop Youssoufian; Stephan Stilgenbauer

doi:10.1097/01.HS9.0000562912.80861.b2

Effect of dose modifications on response to duvelisib in patients with relapsed/refractory CLL/SLL in the duo trial

Paolo Ghia, Ian W. Flinn, Nicole Lamanna, Marco Montillo, Árpád Illés, Gabriel Etienne, Julio Delgado, Bryone Kuss, Constantine Tam, Fritz Offner, Francesco Bosch, Matthew S. Davids, Ulrich Jager, Florence Cymbalista, David T. Weaver, Stephanie Lustgarten, Hagop Youssoufian, Stephan Stilgenbauer

College of Medicine and Public Health

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

Abstract

Background:
Duvelisib (DUV), a first-in-class oral dual PI3K-δ,γ inhibitor, is approved for treatment of relapsed/refractory (R/R) CLL/SLL after ≥ 2 prior therapies. In the phase 3 DUO trial, DUV 25 mg BID significantly improved efficacy vs ofatumumab (OFA; mPFS, 13.3 vs 9.9 mo; HR, 0.52 [P < .0001]; ORR, 74% vs 45% [P < .0001]) in pts with R/R CLL/SLL (Flinn et al. Blood 2018). Treatment-emergent AEs (TEAEs) of special interest (AESIs) such as infections, diarrhea, colitis, neutropenia, rash, ALT/AST elevation, and pneumonitis, were moderate and manageable with early intervention and dose modification.

Original language	English
Pages (from-to)	525
Number of pages	1
Journal	HemaSphere
Volume	3
Issue number	S1
DOIs	https://doi.org/10.1097/01.HS9.0000562912.80861.b2
Publication status	Published - Jun 2019
Event	24th Congress of the European Hematology Association - Amsterdam, Netherlands Duration: 13 Jun 2019 → 16 Jun 2019 Conference number: 24

Keywords

Duvelisib
PI3K-δ,γ inhibitor
relapsed CLL/SLL
Treatment-emergent AEs
Dose modification

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Ghia, P., Flinn, I. W., Lamanna, N., Montillo, M., Illés, Á., Etienne, G., Delgado, J., Kuss, B., Tam, C., Offner, F., Bosch, F., Davids, M. S., Jager, U., Cymbalista, F., Weaver, D. T., Lustgarten, S., Youssoufian, H., & Stilgenbauer, S. (2019). Effect of dose modifications on response to duvelisib in patients with relapsed/refractory CLL/SLL in the duo trial. HemaSphere, 3(S1), 525. https://doi.org/10.1097/01.HS9.0000562912.80861.b2

@article{c73717f176e54cb7815a747710ee005c,

title = "Effect of dose modifications on response to duvelisib in patients with relapsed/refractory CLL/SLL in the duo trial",

abstract = "Background: Duvelisib (DUV), a first-in-class oral dual PI3K-δ,γ inhibitor, is approved for treatment of relapsed/refractory (R/R) CLL/SLL after ≥ 2 prior therapies. In the phase 3 DUO trial, DUV 25 mg BID significantly improved efficacy vs ofatumumab (OFA; mPFS, 13.3 vs 9.9 mo; HR, 0.52 [P < .0001]; ORR, 74% vs 45% [P < .0001]) in pts with R/R CLL/SLL (Flinn et al. Blood 2018). Treatment-emergent AEs (TEAEs) of special interest (AESIs) such as infections, diarrhea, colitis, neutropenia, rash, ALT/AST elevation, and pneumonitis, were moderate and manageable with early intervention and dose modification.",

keywords = "Duvelisib, PI3K-δ,γ inhibitor, relapsed CLL/SLL, Treatment-emergent AEs, Dose modification",

author = "Paolo Ghia and Flinn, {Ian W.} and Nicole Lamanna and Marco Montillo and {\'A}rp{\'a}d Ill{\'e}s and Gabriel Etienne and Julio Delgado and Bryone Kuss and Constantine Tam and Fritz Offner and Francesco Bosch and Davids, {Matthew S.} and Ulrich Jager and Florence Cymbalista and Weaver, {David T.} and Stephanie Lustgarten and Hagop Youssoufian and Stephan Stilgenbauer",

year = "2019",

month = jun,

doi = "10.1097/01.HS9.0000562912.80861.b2",

language = "English",

volume = "3",

pages = "525",

journal = "HemaSphere",

issn = "2572-9241",

publisher = "John Wiley & Sons, Inc",

number = "S1",

note = "24th Congress of the European Hematology Association, EHA24 ; Conference date: 13-06-2019 Through 16-06-2019",

}

Ghia, P, Flinn, IW, Lamanna, N, Montillo, M, Illés, Á, Etienne, G, Delgado, J, Kuss, B, Tam, C, Offner, F, Bosch, F, Davids, MS, Jager, U, Cymbalista, F, Weaver, DT, Lustgarten, S, Youssoufian, H & Stilgenbauer, S 2019, 'Effect of dose modifications on response to duvelisib in patients with relapsed/refractory CLL/SLL in the duo trial', HemaSphere, vol. 3, no. S1, pp. 525. https://doi.org/10.1097/01.HS9.0000562912.80861.b2

TY - JOUR

T1 - Effect of dose modifications on response to duvelisib in patients with relapsed/refractory CLL/SLL in the duo trial

AU - Ghia, Paolo

AU - Flinn, Ian W.

AU - Lamanna, Nicole

AU - Montillo, Marco

AU - Illés, Árpád

AU - Etienne, Gabriel

AU - Delgado, Julio

AU - Kuss, Bryone

AU - Tam, Constantine

AU - Offner, Fritz

AU - Bosch, Francesco

AU - Davids, Matthew S.

AU - Jager, Ulrich

AU - Cymbalista, Florence

AU - Weaver, David T.

AU - Lustgarten, Stephanie

AU - Youssoufian, Hagop

AU - Stilgenbauer, Stephan

N1 - Conference code: 24

PY - 2019/6

Y1 - 2019/6

N2 - Background: Duvelisib (DUV), a first-in-class oral dual PI3K-δ,γ inhibitor, is approved for treatment of relapsed/refractory (R/R) CLL/SLL after ≥ 2 prior therapies. In the phase 3 DUO trial, DUV 25 mg BID significantly improved efficacy vs ofatumumab (OFA; mPFS, 13.3 vs 9.9 mo; HR, 0.52 [P < .0001]; ORR, 74% vs 45% [P < .0001]) in pts with R/R CLL/SLL (Flinn et al. Blood 2018). Treatment-emergent AEs (TEAEs) of special interest (AESIs) such as infections, diarrhea, colitis, neutropenia, rash, ALT/AST elevation, and pneumonitis, were moderate and manageable with early intervention and dose modification.

AB - Background: Duvelisib (DUV), a first-in-class oral dual PI3K-δ,γ inhibitor, is approved for treatment of relapsed/refractory (R/R) CLL/SLL after ≥ 2 prior therapies. In the phase 3 DUO trial, DUV 25 mg BID significantly improved efficacy vs ofatumumab (OFA; mPFS, 13.3 vs 9.9 mo; HR, 0.52 [P < .0001]; ORR, 74% vs 45% [P < .0001]) in pts with R/R CLL/SLL (Flinn et al. Blood 2018). Treatment-emergent AEs (TEAEs) of special interest (AESIs) such as infections, diarrhea, colitis, neutropenia, rash, ALT/AST elevation, and pneumonitis, were moderate and manageable with early intervention and dose modification.

KW - Duvelisib

KW - PI3K-δ,γ inhibitor

KW - relapsed CLL/SLL

KW - Treatment-emergent AEs

KW - Dose modification

U2 - 10.1097/01.HS9.0000562912.80861.b2

DO - 10.1097/01.HS9.0000562912.80861.b2

M3 - Meeting Abstract

SN - 2572-9241

VL - 3

SP - 525

JO - HemaSphere

JF - HemaSphere

IS - S1

T2 - 24th Congress of the European Hematology Association

Y2 - 13 June 2019 through 16 June 2019

ER -

Effect of dose modifications on response to duvelisib in patients with relapsed/refractory CLL/SLL in the duo trial

Abstract

Keywords

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