Olutasidenib in combination with azacitidine induces durable complete remissions in patients with relapsed or refractory mIDH1 acute myeloid leukemia: a multicohort open-label phase 1/2 trial

Ethics approval and consent to participate

The study was performed in accordance with the Declaration of Helsinki and in compliance with good clinical practice guidelines and applicable laws. The protocol was approved by the institutional review boards or ethics committee at study sites. Written informed consent was obtained before study entry from each patient or from the patient’s legally authorized representative if the patient was unable to provide consent.

Consent for publication

Not applicable.

Competing interests

JEC has received research funding for his current or former institution from, and is a consultant to, Astellas, Amphivena, BMS, Novartis, Pfizer, Takeda, Daiichi, Jazz Pharmaceuticals, Merus, and Forma Therapeutics; and is a consultant to Rigel, BiolineRx, Biopath, Sun Pharma, and Tern. GJR has served as a consultant for Agios, Amgen, Amphivena, Astex, Celator, Celgene, Clovis Oncology, CTI BioPharma, Genoptix, Immune Pharmaceuticals, Janssen Pharmaceuticals, Juno, MedImmune, MEI Pharma, Onconova, Pfizer, Roche, and Sunesis; received research funding from AbbVie, BMS, Teva and Karyopharm; is an advisory board member or consultant for Novartis, AbbVie, BeiGene, BerGenBio, Arcellx, Jazz Pharmaceuticals, Syros, BMS, Genentech, ImmunoGen, AstraZeneca, Kura, Ryvu, Magenta, and Qihan Zentalis; has provided research support to Janssen. MRB received research funding from Abbvie, Ascnetage Pharma, Forma Therapeutics, Kite/Gilead, Kura Oncology, and Takeda. BAJ served in a consultancy/advisory role for AbbVie, Bristol Myers Squibb, Daiichi Sankyo, Genentech, Gilead, GlycoMimetics, Kymera, Kura, Rigel, Schrodinger, Servier, Syndax and Treadwell, on a protocol steering committee for GlycoMimetics, on a data monitoring committee for Gilead, received travel reimbursement from AbbVie and Rigel, research funding to institution from AbbVie, Amgen, Aptose, AROG, Biomea, Bristol Myers Squibb, Celgene, Daiichi Sankyo, F. Hoffmann‑La Roche, Forma, Forty‑Seven, Genentech/Roche, Gilead, GlycoMimetics, Hanmi, Immune‑Onc, Incyte, Jazz, Kymera, Loxo, Pfizer, Pharmacyclics, Sigma Tau, and Treadwell. GJS has received advisory board and/or speaker program honoraria from Agios, Stemline, GSK, AVM Biotech, Orca, Novartis, BMS, Rigel, Incyte, Gilead, Gamida, Autolus, Abbvie, Seattle Genetics, Jazz Pharmaceuticals, Kite (Gilead), Karyopharm, BMS/Celgene, Blueprint Medicine, Astellas, and Amgen; has received consultant fees from BMS, Curios, Daichi-Sankyo, and Novartis; and holds stock or stock options in Amgen, Janssen, and BMS. KY was a consultant for Bristol Myers Squibb/Celgene, F. Hoffmann-La Roche, GSK, Jazz Pharmaceuticals, Novartis, Pfizer, Shattuck Labs, Taiho Oncology, and Takeda; received research funding from Astex Pharmaceuticals, Forma Therapeutics, F. Hoffmann-La Roche, Forma Therapeutics, Genentech, Geron Corporation, Gilead Sciences, Janssen Pharmaceuticals, Jazz Pharmaceuticals, Novartis, and Treadwell Therapeutics; and received honoraria from AbbVie, TaiHo, and Novartis. PBF received unrelated research funding from Novartis. JY received research funding from Pfizer, Puretech, and Janssen. ESW served as advisory/consulting for Abbvie, Blueprint, Daiichi Sankyo, Immunogen, Kite, Kura, Novartis, Qiagen, Rigel, Ryvu, Schrodinger, Servier, Stemline, Syndax, Takeda; speaking roles for Pfizer, Astellas, Dava (all with my own slides); served on DSMC for Gilead and Abbvie; and is section editor for UpToDate. WGB has no competing interests to declare. AM served on DSMC for Foghorn Therapeutics, Daiichi Saynko, advisory for BMS, Abbvie, Novartis, treadwell therapeutics, and is senior medical director for beat aml study for the leukemia and lymphoma society. HT and AS are employees and shareholders of Rigel Pharmaceuticals, Inc. SDB 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. PM has served as a consultant and has received research funding from Servier and Bristol Myers Squibb. AC received support for research/honoraria for advisory boards and meetings from Abbvie and Pfizer; received honoraria for advisory board and meetings from Menarini Stemline, Jazz Pharmaceutical and Servier. JMW has received research funding from and was a board/advisory committee member for Takeda; has received research funding from Immune System Key Ltd; and is a consultant or board/advisory committee member for Genentech, Rafael Pharma, Reven Pharma, Celgene/Bristol-Myers Squib (BMS), Servier, Rigel, Aptose, Astellas, and Daiichi-Sankyo. BAJ served in a consultancy/advisory role for AbbVie, Bristol Myers Squibb, Daiichi Sankyo, Genentech, Gilead, GlycoMimetics, Kymera, Kura, Rigel, Schrodinger, Servier, Syndax and Treadwell, on a protocol steering committee for GlycoMimetics, on a data monitoring committee for Gilead, received travel reimbursement from AbbVie and Rigel, research funding to institution from AbbVie, Amgen, Aptose, AROG, Biomea, Bristol Myers Squibb, Celgene, Daiichi Sankyo, F. Hoffmann‑La Roche, Forma, Forty‑Seven, Genentech/Roche, Gilead, GlycoMimetics, Hanmi, Immune‑Onc, Incyte, Jazz, Kymera, Loxo, Pfizer, Pharmacyclics, Sigma Tau, and Treadwell. GJS has received advisory board and/or speaker program honoraria from Agios, Stemline, GSK, AVM Biotech, Orca, Novartis, BMS, Rigel, Incyte, Gilead, Gamida, Autolus, Abbvie, Seattle Genetics, Jazz Pharmaceuticals, Kite (Gilead), Karyopharm, BMS/Celgene, Blueprint Medicine, Astellas, and Amgen; has received consultant fees from BMS, Curios, Daichi-Sankyo, and Novartis; and holds stock or stock options in Amgen, Janssen, and BMS. KY was a consultant for Bristol Myers Squibb/Celgene, F. Hoffmann-La Roche, GSK, Jazz Pharmaceuticals, Novartis, Pfizer, Shattuck Labs, Taiho Oncology, and Takeda; received research funding from Astex Pharmaceuticals, Forma Therapeutics, F. Hoffmann-La Roche, Forma Therapeutics, Genentech, Geron Corporation, Gilead Sciences, Janssen Pharmaceuticals, Jazz Pharmaceuticals, Novartis, and Treadwell Therapeutics; and received honoraria from AbbVie, TaiHo, and Novartis. PBF received unrelated research funding from Novartis. JY received research funding from Pfizer, Puretech, and Janssen. ESW served as advisory/consulting for Abbvie, Blueprint, Daiichi Sankyo, Immunogen, Kite, Kura, Novartis, Qiagen, Rigel, Ryvu, Schrodinger, Servier, Stemline, Syndax, Takeda; speaking roles for Pfizer, Astellas, Dava (all with my own slides); served on DSMC for Gilead and Abbvie; and is section editor for UpToDate. WGB has no competing interests to declare. AM served on DSMC for Foghorn Therapeutics, Daiichi Saynko, advisory for BMS, Abbvie, Novartis, treadwell therapeutics, and is senior medical director for Beat AML study for the Leukemia and Lymphoma Society. HT and AS are employees and shareholders of Rigel Pharmaceuticals, Inc. SDB 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. PM has served as a consultant and has received research funding from Servier and Bristol Myers Squibb. AC received support for research/honoraria for advisory boards and meetings from Abbvie and Pfizer; received honoraria for advisory board and meetings from Menarini Stemline, Jazz Pharmaceutical and Servier. JMW has received research funding from and was a board/advisory committee member for Takeda; has received research funding from Immune System Key Ltd; and is a consultant or board/advisory committee member for Genentech, Rafael Pharma, Reven Pharma, Celgene/Bristol-Myers Squib (BMS), Servier, Rigel, Aptose, Astellas, and Daiichi-Sankyo.

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