Young Rok DoJae Yong KwakJeong A. KimHyeoung Joon KimJoo Seop ChungHo Jin ShinSung Hyun KimUdomsak BunworasateChul Won ChoiDae Young ZangSuk Joong OhSaengsuree JootarAry Harryanto ReksodiputroWon Sik LeeYeung Chul MunJee Hyun KongPriscilla B. CaguioaHawk KimJinny ParkDong Wook KimWonju Severance Christian HospitalKeimyung University, Dongsan Medical CenterInje University Paik HospitalGachon UniversityUniversity of Indonesia, RSUPN Dr. Cipto MangunkusumoEwha Womans University School of MedicineChulalongkorn UniversityHallym UniversityJeonbuk National University, School of MedicineSungKyunKwan University, School of MedicineDong-A UniversityFaculty of Medicine, Ramathibodi Hospital, Mahidol UniversityChonnam National UniversityKorea UniversityPusan National University, College of MedicineThe Catholic University of KoreaSt. Luke’s Medical Center2020-03-262020-03-262020-01-01British Journal of Haematology. (2020)13652141000710482-s2.0-85078900629https://repository.li.mahidol.ac.th/handle/123456789/53884© 2019 The Authors. British Journal of Haematology published by British Society for Haematology and John Wiley & Sons Ltd In the phase 3 study RERISE, patients with newly diagnosed chronic myeloid leukaemia in chronic phase demonstrated significantly faster and higher rates of major molecular response (MMR) with twice-daily radotinib 300 mg (n = 79) or 400 mg (n = 81) than with once-daily imatinib 400 mg (n = 81) after 12 months. With ≥48 months’ follow-up, MMR was higher with radotinib 300 mg (86%) or 400 mg (83%) than with imatinib (75%). Among patients with BCR-ABL1 ≤ 10% at three months, MMR and molecular response 4·5 (MR4·5) were achieved within 48 months by more radotinib-treated patients (300 mg: 84% and 52%, respectively; 400 mg: 74% and 44%, respectively) than imatinib-treated patients (71% and 44%, respectively). Estimated overall and progression-free survival rates at 48 months were not significantly different between imatinib (94% and 94%, respectively) and radotinib 300 mg (99% and 97%, respectively) or 400 mg (95% and 93%, respectively). The treatment failure rate was significantly higher with imatinib (19%) than with radotinib 300 mg (6%; P = 0·0197) or 400 mg (5%; P = 0·0072). Safety profiles were consistent with previous reports; most adverse events occurred within 12 months. Radotinib continues to demonstrate robust, deep molecular responses, suggesting that treatment-free remission may be attainable.Mahidol UniversityMedicineArticleSCOPUS10.1111/bjh.16381