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Summary  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 (MR 4·5 ) 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.

british journal of haematology

Long‐term data from a phase 3 study of radotinib  versus  imatinib in patients with newly diagnosed, chronic myeloid leukaemia in the chronic phase (RERISE)