Safety, efficacy, and PK/PD of vorasidenib in previously treated patients with mIDH1/2 hematologic malignancies: A phase 1 study

Courtney D. DiNardo; Stéphane De Botton; Daniel A. Pollyea; Richard M. Stone; Jessica K. Altman; Amir T. Fathi; Tharin Limsakun; Min Liang; Sung Choe; Mohammad Hossain; Adriana E. Tron; Qian Meng; Stephanie M. Kapsalis; Shuchi S. Pandya; Eytan M. Stein

doi:10.1002/ajh.27005

Safety, efficacy, and PK/PD of vorasidenib in previously treated patients with mIDH1/2 hematologic malignancies: A phase 1 study

Courtney D. DiNardo, Stéphane De Botton, Daniel A. Pollyea, Richard M. Stone, Jessica K. Altman, Amir T. Fathi, Tharin Limsakun, Min Liang, Sung Choe, Mohammad Hossain, Adriana E. Tron, Qian Meng, Stephanie M. Kapsalis, Shuchi S. Pandya, Eytan M. Stein

Leukemia

Research output: Contribution to journal › Letter › peer-review

Original language	English (US)
Pages (from-to)	E233-E236
Journal	American journal of hematology
Volume	98
Issue number	9
DOIs	https://doi.org/10.1002/ajh.27005
State	Published - Sep 2023

ASJC Scopus subject areas

Hematology

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10.1002/ajh.27005

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DiNardo, C. D., De Botton, S., Pollyea, D. A., Stone, R. M., Altman, J. K., Fathi, A. T., Limsakun, T., Liang, M., Choe, S., Hossain, M., Tron, A. E., Meng, Q., Kapsalis, S. M., Pandya, S. S., & Stein, E. M. (2023). Safety, efficacy, and PK/PD of vorasidenib in previously treated patients with mIDH1/2 hematologic malignancies: A phase 1 study. American journal of hematology, 98(9), E233-E236. https://doi.org/10.1002/ajh.27005

DiNardo, CD, De Botton, S, Pollyea, DA, Stone, RM, Altman, JK, Fathi, AT, Limsakun, T, Liang, M, Choe, S, Hossain, M, Tron, AE, Meng, Q, Kapsalis, SM, Pandya, SS & Stein, EM 2023, 'Safety, efficacy, and PK/PD of vorasidenib in previously treated patients with mIDH1/2 hematologic malignancies: A phase 1 study', American journal of hematology, vol. 98, no. 9, pp. E233-E236. https://doi.org/10.1002/ajh.27005

@article{6891939acb2f4451b13b93c017cd679c,

title = "Safety, efficacy, and PK/PD of vorasidenib in previously treated patients with mIDH1/2 hematologic malignancies: A phase 1 study",

author = "DiNardo, {Courtney D.} and {De Botton}, St{\'e}phane and Pollyea, {Daniel A.} and Stone, {Richard M.} and Altman, {Jessica K.} and Fathi, {Amir T.} and Tharin Limsakun and Min Liang and Sung Choe and Mohammad Hossain and Tron, {Adriana E.} and Qian Meng and Kapsalis, {Stephanie M.} and Pandya, {Shuchi S.} and Stein, {Eytan M.}",

note = "Funding Information: Medical writing assistance was provided by David Pertab, PhD, and Christine Ingleby, DPhil, CMPP, Excel Medical Affairs, Glasgow, UK, and supported by Servier Pharmaceuticals LLC. Funding Information: The study was supported by Agios Pharmaceuticals, Inc. Servier Pharmaceuticals LLC, which funded medical writing assistance, has completed acquisition of Agios' oncology business. Funding Information: C.D.D. has consulted for AbbVie and Servier; received research funding from AbbVie, Astex, BMS, Cleave, Foghorn, Forma, Immune‐Onc, Loxo, and Servier; received honoraria from Astellas, Bluebird Bio, BMS, Foghorn, Gilead, Immune‐Onc, Jazz, Novartis, Kura, Servier, and Takeda; has a membership of the board of directors or advisory roles with Genmab, GSK, Kura, and Notable Labs; and has stock options with Notable Labs. S.D.B. has received honoraria from AbbVie, Astellas Pharma, Bristol Myers Squibb, Jazz Pharmaceuticals, and Servier; has acted as a consultant or advisor to Bristol Myers Squibb, GlaxoSmithKline, Servier, and Syndax; has participated in speakers' bureau for AbbVie, Astellas Pharma, Bristol Myers Squibb, Jazz Pharmaceuticals, and Servier; has received research funding to his institution from Auron Therapeutics and Forma Therapeutics; and has received travel, accommodations, or expenses from AbbVie and Servier. D.A.P. has acted as a consultant or advisor to AbbVie, Celgene, Bristol Myers Squibb, Takeda, Foghorn, Aprea, Genentech, Syros, Novartis, Gilead, Astellas, Karyopharm, Syndax, Jazz, Bergen Bio, Arcellx, AstraZeneca, Kura, Ryvu, Magenta, Qihan, Zentalis, Medivir, HiberCell, and has received research funding from AbbVie, Bristol Myers Squibb, Teva, and Karyopharm. R.M.S. reports grants and personal fees from AbbVie, Agios, and Novartis; personal fees from Actinium, Astellas, BioLineRx, Celgene, Daiichi‐Sankyo, Elevate, GEMoaB, Janssen, Jazz, MacroGenics, Onconova, Syndax, Syntrix, Syros, Takeda, Trovagene, BerGenBio, Foghorn Therapeutics, GlaxoSmithKline, Aprea, Innate, Amgen, BMS, Boston Pharmaceuticals, Aptevo, Epizyme, Kura Oncology, and grants from AROG, outside the submitted work. J.K.A. has acted as a consultant or advisor for AbbVie, Astellas Pharma, BioSight, Bluebird Bio, Curio, Gilead, Kura Oncology, Kymera, Stemline Therapeutics, and Syros; received research funding from Servier; and received travel, accommodations, or travel‐related expenses from BioSight. A.T.F. has consulted for AbbVie, Agios, Amgen, Astellas, Bristol Myers Squibb, Celgene, EnClear, Forma, Genentech, Immunogen, Ipsen, Kite, Mablytics, Novartis, Orum, PureTech, Servier, and Takeda; and has received funding for clinical trials from AbbVie, Agios/Servier, and Celgene/Bristol Myers Squibb. E.M.S. has acted as a consultant or advisor to Novartis, Janssen, BMS/Celgene, Agios, Jazz Pharmaceuticals, Menarini, Genentech, Genesis Pharma, AbbVie, Neoleukin Therapeutics, Gilead Sciences, Syndax, OnCusp Therapeutics, Immunogen, CTI BioPharma Corp, Foghorn Therapeutics, Servier, Calithera Biosciences, Daiichi Sankyo, Aptose Biosciences, Ono Pharmaceutical, Blueprint Medicines, GEMoaB, Jnana Therapeutics, and Debiopharm Group; has stock or ownership in Auron Therapeutics; and has received research funding to his institution from Eisai, BMS/Celgene, Bayer, Agios, BioTheryX, Syros Pharmaceuticals, Servier, Foghorn Therapeutics, Syndax, Gilead Sciences, Cleave Biosciences, Prelude Therapeutics, and Loxo/Lilly. T.L., S.C., M.H., A.E.T., Q.M., S.M.K., and S.S.P. are employees of Servier. M.L., S.C., M.H., A.E.T., S.M.K., and S.S.P. were employees of Agios at the time of conducting these studies. ",

year = "2023",

month = sep,

doi = "10.1002/ajh.27005",

language = "English (US)",

volume = "98",

pages = "E233--E236",

journal = "American journal of hematology",

issn = "0361-8609",

publisher = "Wiley-Liss Inc.",

number = "9",

}

TY - JOUR

T1 - Safety, efficacy, and PK/PD of vorasidenib in previously treated patients with mIDH1/2 hematologic malignancies

T2 - A phase 1 study

AU - DiNardo, Courtney D.

AU - De Botton, Stéphane

AU - Pollyea, Daniel A.

AU - Stone, Richard M.

AU - Altman, Jessica K.

AU - Fathi, Amir T.

AU - Limsakun, Tharin

AU - Liang, Min

AU - Choe, Sung

AU - Hossain, Mohammad

AU - Tron, Adriana E.

AU - Meng, Qian

AU - Kapsalis, Stephanie M.

AU - Pandya, Shuchi S.

AU - Stein, Eytan M.

N1 - Funding Information: Medical writing assistance was provided by David Pertab, PhD, and Christine Ingleby, DPhil, CMPP, Excel Medical Affairs, Glasgow, UK, and supported by Servier Pharmaceuticals LLC. Funding Information: The study was supported by Agios Pharmaceuticals, Inc. Servier Pharmaceuticals LLC, which funded medical writing assistance, has completed acquisition of Agios' oncology business. Funding Information: C.D.D. has consulted for AbbVie and Servier; received research funding from AbbVie, Astex, BMS, Cleave, Foghorn, Forma, Immune‐Onc, Loxo, and Servier; received honoraria from Astellas, Bluebird Bio, BMS, Foghorn, Gilead, Immune‐Onc, Jazz, Novartis, Kura, Servier, and Takeda; has a membership of the board of directors or advisory roles with Genmab, GSK, Kura, and Notable Labs; and has stock options with Notable Labs. S.D.B. has received honoraria from AbbVie, Astellas Pharma, Bristol Myers Squibb, Jazz Pharmaceuticals, and Servier; has acted as a consultant or advisor to Bristol Myers Squibb, GlaxoSmithKline, Servier, and Syndax; has participated in speakers' bureau for AbbVie, Astellas Pharma, Bristol Myers Squibb, Jazz Pharmaceuticals, and Servier; has received research funding to his institution from Auron Therapeutics and Forma Therapeutics; and has received travel, accommodations, or expenses from AbbVie and Servier. D.A.P. has acted as a consultant or advisor to AbbVie, Celgene, Bristol Myers Squibb, Takeda, Foghorn, Aprea, Genentech, Syros, Novartis, Gilead, Astellas, Karyopharm, Syndax, Jazz, Bergen Bio, Arcellx, AstraZeneca, Kura, Ryvu, Magenta, Qihan, Zentalis, Medivir, HiberCell, and has received research funding from AbbVie, Bristol Myers Squibb, Teva, and Karyopharm. R.M.S. reports grants and personal fees from AbbVie, Agios, and Novartis; personal fees from Actinium, Astellas, BioLineRx, Celgene, Daiichi‐Sankyo, Elevate, GEMoaB, Janssen, Jazz, MacroGenics, Onconova, Syndax, Syntrix, Syros, Takeda, Trovagene, BerGenBio, Foghorn Therapeutics, GlaxoSmithKline, Aprea, Innate, Amgen, BMS, Boston Pharmaceuticals, Aptevo, Epizyme, Kura Oncology, and grants from AROG, outside the submitted work. J.K.A. has acted as a consultant or advisor for AbbVie, Astellas Pharma, BioSight, Bluebird Bio, Curio, Gilead, Kura Oncology, Kymera, Stemline Therapeutics, and Syros; received research funding from Servier; and received travel, accommodations, or travel‐related expenses from BioSight. A.T.F. has consulted for AbbVie, Agios, Amgen, Astellas, Bristol Myers Squibb, Celgene, EnClear, Forma, Genentech, Immunogen, Ipsen, Kite, Mablytics, Novartis, Orum, PureTech, Servier, and Takeda; and has received funding for clinical trials from AbbVie, Agios/Servier, and Celgene/Bristol Myers Squibb. E.M.S. has acted as a consultant or advisor to Novartis, Janssen, BMS/Celgene, Agios, Jazz Pharmaceuticals, Menarini, Genentech, Genesis Pharma, AbbVie, Neoleukin Therapeutics, Gilead Sciences, Syndax, OnCusp Therapeutics, Immunogen, CTI BioPharma Corp, Foghorn Therapeutics, Servier, Calithera Biosciences, Daiichi Sankyo, Aptose Biosciences, Ono Pharmaceutical, Blueprint Medicines, GEMoaB, Jnana Therapeutics, and Debiopharm Group; has stock or ownership in Auron Therapeutics; and has received research funding to his institution from Eisai, BMS/Celgene, Bayer, Agios, BioTheryX, Syros Pharmaceuticals, Servier, Foghorn Therapeutics, Syndax, Gilead Sciences, Cleave Biosciences, Prelude Therapeutics, and Loxo/Lilly. T.L., S.C., M.H., A.E.T., Q.M., S.M.K., and S.S.P. are employees of Servier. M.L., S.C., M.H., A.E.T., S.M.K., and S.S.P. were employees of Agios at the time of conducting these studies.

PY - 2023/9

Y1 - 2023/9

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U2 - 10.1002/ajh.27005

DO - 10.1002/ajh.27005

M3 - Letter

C2 - 37354069

AN - SCOPUS:85162870577

SN - 0361-8609

VL - 98

SP - E233-E236

JO - American journal of hematology

JF - American journal of hematology

IS - 9

ER -

Safety, efficacy, and PK/PD of vorasidenib in previously treated patients with mIDH1/2 hematologic malignancies: A phase 1 study

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