NDLI: 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)

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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)

Content Provider	Scilit
Author	Do, Young Rok Kwak, Jae‐Yong Kim, Jeong A. Kim, Hyeoung Joon Chung, Joo Seop Shin, Ho‐Jin Kim, Sung‐Hyun Bunworasate, Udomsak Choi, Chul Won Zang, Dae Young Oh, Suk Joong Jootar, Saengsuree Reksodiputro, Ary Harryanto Lee, Won Sik Mun, Yeung‐Chul Kong, Jee Hyun Caguioa, Priscilla B. Kim, Hawk Park, Jinny Kim, Dong‐Wook
Copyright Year	2020
Description	Journal: British Journal of Haematology 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.
Related Links	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7187446/pdf
Ending Page	312
Page Count	10
Starting Page	303
e-ISSN	13652141
DOI	10.1111/bjh.16381
Journal	British Journal of Haematology
Issue Number	2
Volume Number	189
Language	English
Publisher	Wiley-Blackwell
Publisher Date	2020-02-03
Access Restriction	Open
Subject Keyword	Journal: British Journal of Haematology Chronic Myeloid Leukaemia Newly Diagnosed Long‐term Data
Content Type	Text
Resource Type	Article

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