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)

• Main Authors: Young Rok Do, Jae Yong Kwak, Jeong A. Kim, Hyeoung Joon Kim, Joo Seop Chung, Ho Jin Shin, Sung Hyun Kim, Udomsak Bunworasate, Chul Won Choi, Dae Young Zang, Suk Joong Oh, Saengsuree Jootar, Ary Harryanto Reksodiputro, Won Sik Lee, Yeung Chul Mun, Jee Hyun Kong, Priscilla B. Caguioa, Hawk Kim, Jinny Park, Dong Wook Kim
• Other Authors: Wonju Severance Christian Hospital
• Format: Article
• Published: 2020
• Subjects: Medicine
• Online Access: https://repository.li.mahidol.ac.th/handle/123456789/53884
• Institution: Mahidol University

© 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.