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)

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

Research output: Contribution to journalArticle

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Abstract

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.

Original languageEnglish
JournalBritish Journal of Haematology
DOIs
Publication statusAccepted/In press - 2020 Jan 1

Keywords

  • chronic myeloid leukaemia
  • imatinib
  • long-term data
  • newly diagnosed
  • radotinib

ASJC Scopus subject areas

  • Hematology

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  • Cite this

    Do, Y. R., Kwak, J. Y., Kim, J. A., Kim, H. J., Chung, J. S., Shin, H. J., Kim, S. H., Bunworasate, U., Choi, C. W., Zang, D. Y., Oh, S. J., Jootar, S., Reksodiputro, A. H., Lee, W. S., Mun, Y. C., Kong, J. H., Caguioa, P. B., Kim, H., Park, J., & Kim, D. W. (Accepted/In press). 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). British Journal of Haematology. https://doi.org/10.1111/bjh.16381