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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)
Author(s) -
Do Young Rok,
Kwak JaeYong,
Kim Jeong A.,
Kim Hyeoung Joon,
Chung Joo Seop,
Shin HoJin,
Kim SungHyun,
Bunworasate Udomsak,
Choi Chul Won,
Zang Dae Young,
Oh Suk Joong,
Jootar Saengsuree,
Reksodiputro Ary Harryanto,
Lee Won Sik,
Mun YeungChul,
Kong Jee Hyun,
Caguioa Priscilla B.,
Kim Hawk,
Park Jinny,
Kim DongWook
Publication year - 2020
Publication title -
british journal of haematology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.907
H-Index - 186
eISSN - 1365-2141
pISSN - 0007-1048
DOI - 10.1111/bjh.16381
Subject(s) - imatinib , medicine , chronic myeloid leukaemia , gastroenterology , adverse effect , imatinib mesylate , myeloid leukemia
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.