Asciminib monotherapy in patients with CML-CP without BCR::ABL1 T315I mutations treated with at least two prior TKIs: 4-year phase 1 safety and efficacy results.

"Competing interests MJM: Bristol Myers Squibb, Takeda, and Pfizer: personal fees. TPH: Novartis, Bristol Myers Squibb, and Enliven: consultancy, research funding. D-WK: Novartis, Bristol Myers Squibb, Pfizer, IL-YANG, and Takeda: grants. DR: Novartis, Pfizer, and Incyte: personal fees. JEC: Novartis, Pfizer, and Bristol Myers Squibb: grants, consulting fees. AH: Bristol Myers Squibb, Pfizer: institutional research support; Novartis and Incyte: institutional research support, personal fees. KS: Novartis: research funding, honoraria. MB: Bristol Myers Squibb, Celgene, Pfizer, Incyte, and Novartis: consultancy and honoraria; AbbVie: consultancy. MT: IMAGO: consultancy; Novartis and Takeda: research funding; Constellation Pharmaceuticals and Bristol Myers Squibb: membership on board of directors or advisory committees. OO: Amgen, Incyte, Celgene, Roche, Fusion Pharma, Novartis: honoraria. Amgen, Incyte, and Celgene: research funding. HM: Bayer, Bristol Myers Squibb Japan, Celgene, Chugai Pharma, Daiichi Sankyo, Dainippon Sumitomo Pharma, Eisai, Kyowa Hakko Kirin, Lilly Japan, Novartis, Ono Pharmaceutical, Otsuka, Pfizer, Taiho Pharmaceutical, Takeda, MSD, and AbbVie: honoraria; Ono Pharmaceutical: consulting; Astellas Pharma, Chugai Pharma, Dainippon Sumitomo Pharma, Eisai, Kyowa Hakko Kirin, Lilly Japan, Ono Pharmaceutical, Taiho Pharmaceutical, Nippon Shinyaku, MSD, Boehringer Ingelheim, Daiichi Sankyo, Takeda, Nihonkayaku, Shionogi, Sanofi, Bayer Schering Pharma, Mitsubishi Tanabe Pharma, and Teijin Pharma: research funding. YTG: Pfizer, Johnson & Johnson, Amgen, MSD Pharma, Novartis, EUSA Pharma, Roche, Bristol Myers Squibb, and AbbVie: honoraria. DJD: AbbVie, Novartis, Blueprint, and GlycoMimetics: grants; AbbVie, Novartis, Blueprint and GlycoMimetics: research funding; AbbVie, Amgen, Autolus, Blueprint, Forty-Seven, GlycoMimetics, Incyte, Jazz, Kite, Novartis, Pfizer, Servier, and Takeda; consulting. AbbvVie, Amgen, Autolus, Blueprint, Forty-Seven, GlycoMimetics, Incyte, Jazz, Kite, Novartis, Pfizer, Servier, and Takeda: personal fees. MCH: Novartis, Deciphera, Theseus and Blueprint Medicines: consultancy; Deciphera: speaker’s bureau; Jonathan David Foundation, VA Merit Review Grant (I01BX005358), and NCI R21 grant (R21CA263400): partial salary support. Prior to 2019, MCH held an equity interest in MolecularMD. MCH holds multiple patents on the diagnosis and/or treatment of gastrointestinal stromal tumors; one patent on treatment has been licensed by Oregon Health & Science University to Novartis. VGGdS: Novartis, Pfizer, Bristol Myers Squibb, and Incyte: grants, nonfinancial support, and honoraria. PC: Pfizer, Novartis, and Incyte: honoraria. F-XM: Novartis: grants, honoraria, consultancy, and research funding; Bristol Myers Squibb and Pfizer: honoraria. JJWMJ: Novartis and Bristol Myers Squibb: research funding; Incyte: speaker’s fee; AbbVie, Novartis, Pfizer, and Incyte: honoraria; AbbVie, Alexion, Amgen, Astellas, Bristol Myers Squibb, Daiichi Sankyo, Janssen-Cilag, Olympus, Incyte, Sanofi Genzyme, Servier, Jazz, and Takeda: support for Apps for Care and Science nonprofit foundation of which JJWMJ is president. MD: Fusion Pharma, Blueprint, Pfizer, Novartis, Medscape, and Sangoma: consultancy; Pfizer: research funding; Takeda, Sangomo, and Blueprint: membership on board of directors or advisory committees. NS: Novartis: honoraria. Amgen: support for attending meetings and/or travel. MBG: National Cancer Institute, Amgen, Sanofi, Actinium Pharmaceuticals, Inc.: grants; Allogene: consulting. Sanofi and American Society of Hematology: honoraria. SC, FP, NA, and MH are employees of Novartis. FL: Bristol Myers Squibb, Incyte, and Celgene: consultancy, honoraria; Novartis: consultancy, honoraria, and research funding."

"Funding This study was sponsored and funded by Novartis Pharmaceuticals."